A prospective randomized trial using solvent dehydrated fascia lata for the prevention of recurrent anterior vaginal wall prolapse. A randomized controlled trial comparing short versus long-term catheterization after uncomplicated vaginal prolapse surgery. A randomised controlled trial comparing immediate versus delayed catheter removal following vaginal prolapse surgery. Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT) Outcome reporting across randomized trials and observational studies evaluating treatments for twin–twin transfusion syndrome: systematic review A prospective, randomized, controlled trial of the treatment of anterior vaginal wall prolapse: medium term followup. Absorbable Mesh Augmentation Compared With No Mesh for Anterior Prolapse: A Randomized Controlled Trial A randomized comparison of tension-free vaginal tape and endopelvic fascia plication in women with genital prolapse and occult stress urinary incontinence. Comparison between trans-obturator trans-vaginal mesh and traditional anterior colporrhaphy in the treatment of anterior vaginal wall prolapse: results of a French RCT Multicenter, randomized trial comparing native vaginal tissue repair and synthetic mesh repair for genital prolapse surgical treatment The use of transvaginal synthetic mesh for anterior vaginal wall prolapse repair: a randomized controlled trial Two-years results of native tissue versus vaginal mesh repair in the treatment of anterior prolapse according to different success criteria: A randomized controlled trial. Optimal duration of urinary catheterization after anterior colporrhaphy Treatment of anterior vaginal wall prolapse with and without polypropylene mesh: a prospective, randomized and controlled trial - Part I. A randomized comparison of polypropylene mesh surgery with site-specific surgery in the treatment of cystocoele One-day versus 3-day suprapubic catheterization after vaginal prolapse surgery: a prospective randomized trial A prospective, randomized, controlled study comparing Gynemesh®, a synthetic mesh, and Pelvicol®, a biologic graft, in the surgical treatment of recurrent cystocele Vaginal Mesh for Prolapse: A Randomized Controlled Trial Sexual function following trocar-guided mesh or vaginal native tissue repair in recurrent prolapse: a randomized controlled trial. Porcine skin collagen implants for anterior vaginal wall prolapse: a randomised prospective controlled study A randomized trial of local anesthesia with intravenous sedation vs general anesthesia for the vaginal correction of pelvic organ prolapse Prophylactic phenoxybenzamine in the prevention of postoperative retention of urine after vaginal repair: a prospective randomized double-blind trial. Clinical efficacy of a trocar-guided mesh kit for repairing lateral defects Postoperative catheterization after anterior colporrhaphy: 2 versus 5 days. A multicentre randomized controlled trial A protocol for developing, disseminating, and implementing a core outcome set for pre-eclampsia. Sexual function after anterior vaginal wall prolapse surgery Twin–Twin Transfusion Syndrome: study protocol for developing, disseminating, and implementing a core outcome set Postoperative infections due to bladder catheters after anterior colporrhaphy: a prospective, randomized three-arm study Low-Weight Polypropylene Mesh for Anterior Vaginal Wall Prolapse: A Randomized Controlled Trial Vaginal versus abdominal reconstructive surgery for the treatment of pelvic support defects: a prospective randomized study with long-term outcome evaluation. Bowel Preparation Before Vaginal Prolapse Surgery: A Randomized Controlled Trial Pelvic organ prolapse surgery with and without tension-free vaginal tape in women with occult or asymptomatic urodynamic stress incontinence: a randomised controlled trial Primary surgical repair of anterior vaginal prolapse: a randomised trial comparing anatomical and functional outcome between anterior colporrhaphy and trocar‐guided transobturator anterior mesh Effect of vaginal infiltration with ornipressin or saline on intraoperative blood loss during vaginal prolapse surgery: a randomised controlled trial Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. Anterior colporrhaphy versus repair with mesh for anterior vaginal wall prolapse: a comparative clinical study Effects of vaginal prolapse surgery on sexuality in women and men; results from a RCT on repair with and without mesh. The value of vaginal packing in pelvic floor surgery: a randomised double-blind study Vaginal prolapse repair with or without a midurethral sling in women with genital prolapse and occult stress urinary incontinence: a randomized trial Anterior transobturator polypropylene mesh in the correction of cystocele: 2-point method vs 4-point method. Development of de novo prolapse in untreated vaginal compartments after prolapse repair with and without mesh: a secondary analysis of a randomised controlled trial Anterior colporrhaphy: a randomized trial of three surgical techniques. A prospective, randomised, controlled trial comparing 3 hour and 24 hour postoperative removal of bladder catheter and vaginal pack following vaginal prolapse surgery A midurethral sling to reduce incontinence after vaginal prolapse repair. Colporrhaphy Compared With Mesh or Graft-Reinforced Vaginal Paravaginal Repair for Anterior Vaginal Wall Prolapse: A Randomized Controlled Trial Long‐term outcome of porcine skin graft in surgical treatment of recurrent pelvic organ prolapse. An open randomized controlled multicenter study Anterior Repair With or Without Collagen Matrix Reinforcement: A Randomized Controlled Trial A Comparison of Suprapubic and Transurethral Catheterization on Postoperative Urinary Retention after Vaginal Prolapse Repair: A Randomized Controlled Trial How long should urinary bladder catheterisation be continued after vaginal prolapse surgery? Anterior vaginal wall prolapse: a randomized controlled trial of SIS graft versus traditional colporrhaphy Treatment of anterior vaginal wall prolapse with and without polypropylene mesh: a prospective, randomized and controlled trial - Part II. Symptom resolution and sexual function after anterior vaginal wall repair with or without polypropylene mesh Lower exposure rates of partially absorbable mesh compared to nonabsorbable mesh for cystocele treatment: 3-year follow-up of a prospective randomized trial Diagnostic Accuracy of Retrograde and Spontaneous Voiding Trials for Postoperative Voiding Dysfunction: A Randomized Controlled Trial A randomized controlled trial comparing anatomical and functional outcome between vaginal colposuspension and transvaginal mesh Reanalysis of a randomized trial of 3 techniques of anterior colporrhaphy using clinically relevant definitions of success. Prevalence, etiology and risk factors of pelvic organ prolapse in premenopausal primiparous women Lack of effect of concomitant stage II cystocele repair on lower urinary tract symptoms and surgical outcome after tension-free vaginal tape procedure: randomized controlled trial Trocar-Guided Mesh Compared With Conventional Vaginal Repair in Recurrent Prolapse: A Randomized Controlled Trial Randomized controlled trial comparing two procedures for anterior vaginal wall prolapse. Bowel Function After Minimally Invasive Urogynecologic Surgery: A Prospective Randomized Controlled Trial Burch colposuspension does not provide any additional benefit to pelvic organ prolapse repair in patients with urinary incontinence: a randomized surgical trial. Surgical strategies for women with pelvic organ prolapse and urinary stress incontinence Urodynamic assessment of anterior vaginal wall surgery: a randomized comparison between colporraphy and transvaginal mesh. Antimicrobial mesh versus vaginal wall sling: a comparative outcomes analysis. Prospective randomized trial of polyglactin 910 mesh to prevent recurrence of cystoceles and rectoceles. Anatomical and functional assessment of anterior colporrhaphy versus polypropylene mesh surgery in cystocele treatment. Clinical effectiveness and cost-effectiveness of surgical options for the management of anterior and/or posterior vaginal wall prolapse: two randomised controlled trials within a comprehensive cohort study - results from the PROSPECT Study. Randomized controlled trial of cystocele plication risks: a pilot study. A randomised controlled trial evaluating the use of polyglactin (Vicryl) mesh, polydioxanone (PDS) or polyglactin (Vicryl) sutures for pelvic organ prolapse surgery: outcomes at 2 years To Pack or Not to Pack? A Randomized Trial of Vaginal Packing After Vaginal Reconstructive Surgery Effects of dexamethasone on quality of recovery following vaginal surgery: a randomized trial. 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OBJECTIVE This study was undertaken to compare outcomes after anterior colporrhaphy with and without a solvent dehydrated cadaveric fascia lata graft . STUDY DESIGN A total of 162 women were enrolled in a prospect i ve , r and omized trial that evaluated the impact of a solvent dehydrated cadaveric fascia lata patch on recurrent anterior vaginal prolapse .  Subjects were r and omly assigned to st and ard colporrhaphy with or without a patch . Before and after surgery , subjects were evaluated by both the Baden-Walker and pelvic organ prolapse quantification systems . " Failure " was defined as stage II anterior wall prolapse or worse . RESULTS Of 154 women r and omly assigned ( 76 patch : 78 no patch ) , all underwent surgery and 153 ( 99 % ) returned for follow-up . Sixteen women ( 21 % ) in the patch group and 23 ( 29 % ) in the control group experienced recurrent anterior vaginal wall prolapse ( P = .229 ) . Only 26 % of all recurrences were symptomatic . Concomitant transvaginal Cooper 's ligament sling procedures were associated with a dramatic decrease in recurrent prolapse ( odds ratio [ OR ] 0.105 , P < .0001 ) . CONCLUSION Solvent dehydrated fascia lata as a barrier does not decrease recurrent prolapse after anterior colporrhaphy . Transvaginal bladder neck slings were associated with a significant reduction in the risk of recurrent anterior wall prolapse AIMS Routine catheterization following vaginal prolapse surgery has advantages like prevention of postoperative retention of urine and prevention of any adverse effect on surgical outcome . However , it increases the risk of urinary tract infection ( UTI ) , prevent early ambulation and prolong hospital stay . This r and omized controlled trial was done on how best to minimize catheter related complication after prolapse surgery . METHODS 200 patients planned for vaginal prolapse surgery were recruited and r and omized into two groups . In group I and group II catheter was removed on 1(st ) and 4(th ) post operative day , respectively . After removal , if patient could not void or when residual urine volume exceeds 150 mL , recatheterisation was done for another three days . Sample of urine was sent for culture during catheter removal . RESULTS Age , parity , type of surgery and mean operation time did not differ significantly between the two groups . Mean duration of catheterization  was significantly shorter ( 1.64 vs 4.09 ) and mean duration of hospital stay was shorter by 1.2 days , in first group . However a significantly higher number of retention of urine or residual urine more than 150 mL was found in the early removal group ( OR 3.10 ) but lesser chance of development of urinary tract infection ( OR 0.10 ) . CONCLUSIONS The early removal of catheter seems more advantageous , with lower incidence of urinary tract infection and a shorter hospital stay although associated with an increased risk of recatheterisation OBJECTIVE It is unclear if any catheterisation is necessary after vaginal surgery for pelvic organ prolapse . The aim of this study was to determine if indwelling catheterisation is necessary after these procedures . STUDY DESIGN A r and omised controlled trial of immediate post-operative removal of catheter compared to a suprapubic catheter ( SPC )  after vaginal prolapse surgery . In the Suprapubic group the catheter was left on free drainage until a voiding trial was commenced at 48h . Women in the immediate removal group underwent in/out catheterisation only if they had not voided by 8h after surgery to ensure the bladder did not over-distend . RESULTS 55 % ( n=17 ) of patients in the immediate removal group did not require catheterisation postoperatively . A further 13 ( 42 % ) patients only required one in/out catheterisation 8h post operatively . In the immediate removal group duration of catheterisation was significantly shorter ( median 0h , IQR 0 - 8h , range 0 - 16h ) vs ( 6days ( IQR 2 - 8days , range 2 - 19h ) p=0.001 ) . The duration of hospital stay ( 7days ( range 3 - 16 ) vs. 9 ( range 3 - 27 ) p=0.014 ) , day of first mobilisation ( Day 1 , range 0 - 2 , vs. Day 2 , range 1 - 4 , p=0.001 ) , and rate of Symptomatic bacturia ( 16 % vs. 52 % , p<0.01 ) were all significantly better with immediate catheter removal . CONCLUSIONS After vaginal surgery for pelvic organ prolapse , the majority of patients do not require extended catheterisation . Early removal of a catheter reduces urinary tract infection and significantly decreases hospital stay . Such a policy should result in improved patient satisfaction and reduced hospital costs BACKGROUND The use of transvaginal mesh and biological graft material in prolapse surgery is controversial and has led to a number of enquiries into their safety and efficacy . Existing trials of these augmentations are individually too small to be conclusive . We aim ed to compare the outcomes of prolapse repair involving either synthetic mesh inlays or biological grafts against st and ard repair in women . METHODS We did two pragmatic , parallel-group , multicentre , r and omised controlled trials for our study ( PROSPECT [ PROlapse Surgery : Pragmatic Evaluation and r and omised Controlled Trials ] ) in 35 centres ( a mix of secondary and tertiary referral hospitals ) in the UK . We recruited women undergoing primary transvaginal anterior or posterior compartment prolapse surgery by 65 gynaecological surgeons in these centres . We r and omly assigned participants by a remote web-based r and omisation system to one of the two trials : comparing st and ard ( native tissue ) repair alone with st and ard repair augmented with either synthetic mesh ( the mesh trial ) or biological graft ( the graft trial ) . We assigned women ( 1:1:1 or 1:1 ) within three strata : assigned to one of the three treatment options , comparison of st and ard repair with mesh , and comparison of st and ard repair with graft . Participants , ward staff , and outcome assessors were masked to r and omisation where possible ; masking was obviously not possible for the surgeon . Follow-up was for 2 years after the surgery ; the primary outcomes , measured at 1 year and 2 years , were participant-reported prolapse symptoms ( i.e. the Pelvic Organ Prolapse Symptom Score [ POP-SS ] ) and condition-specific ( ie , prolapse-related ) quality -of-life scores , analysed in the modified intention-to-treat population . This trial is registered as an International St and ard R and omised Controlled Trial , number IS RCT N60695184 . FINDINGS Between Jan 8 , 2010 , and Aug 30 , 2013 , we r and omly allocated 1352 women to treatment , of whom 1348 were included in the analysis . 865 women were included in the mesh  trial ( 430 to st and ard repair alone , 435 to mesh augmentation ) and 735 were included in the  graft trial ( 367 to st and ard repair alone , 368 to graft augmentation ) . Because the analyses were carried out separately for each trial ( mesh trial and graft trial ) some women in the st and ard repair arm assigned to all treatment options were included in the st and ard repair group of both trials . 23 of these women did not receive any surgery ( 15 in the mesh trial , 13 in the graft trial ; five were included in both trials ) and were included in the baseline analyses only . Mean POP-SS at 1 year did not differ substantially between comparisons ( st and ard 5·4 [ SD 5·5 ] vs mesh 5·5 [ 5·1 ] , mean difference 0·00 , 95 % CI -0·70 to 0·71 ; p=0·99 ; st and ard 5·5 [ SD 5·6 ] vs graft 5·6 [ 5·6 ] ; mean difference -0·15 , -0·93 to 0·63 ; p=0·71 ) . Mean prolapse-related quality -of-life scores also did not differ between groups at 1 year ( st and ard 2·0 [ SD 2·7 ] vs mesh 2·2 [ 2·7 ] , mean difference 0·13 , 95 % CI -0·25 to 0·51 ; p=0·50 ; st and ard 2·2 [ SD 2·8 ] vs graft 2·4 [ 2·9 ] ; mean difference 0·13 , -0·30 to 0·56 ; p=0·54 ) . Mean POP-SS at 2 years were : st and ard 4·9 ( SD 5·1 ) versus mesh 5·3 ( 5·1 ) , mean difference 0·32 , 95 % CI -0·39 to 1·03 ; p=0·37 ; st and ard 4·9 ( SD 5·1 ) versus graft 5·5 ( 5·7 ) ; mean difference 0·32 , -0·48 to 1·12 ; p=0·43 . Prolapse-related quality -of-life scores at 2 years were : st and ard 1·9 ( SD 2·5 ) versus mesh 2·2 ( 2·6 ) , mean difference 0·15 , 95 % CI -0·23 to 0·54 ; p=0·44 ; st and ard 2·0 ( 2·5 ) versus graft 2·2 ( 2·8 ) ; mean difference 0·10 , -0·33 to 0·52 ; p=0·66 . Serious adverse events such as infection , urinary retention , or dyspareunia or other pain , excluding mesh complications , occurred with similar frequency in the groups over 1 year ( mesh trial : 31/430 [ 7 % ] with st and ard repair vs 34/435 [ 8 % ] with mesh , risk ratio [ RR ] 1·08 , 95 % CI 0·68 to 1·72 ; p=0·73 ; graft trial : 23/367 [ 6 % ] with st and ard repair vs 36/368 [ 10 % ] with graft , RR 1·57 , 0·95 to 2·59 ; p=0·08 ) . The cumulative number of women with a mesh complication over 2 years in women actually exposed to synthetic mesh was 51 ( 12 % ) of 434 . INTERPRETATION Augmentation of a vaginal repair with mesh or graft material did not improve women 's outcomes in terms of effectiveness , quality of life , adverse effects , or any other outcome in the short term , but more than one in ten women had a mesh complication . Therefore , follow-up is vital to identify any longer-term potential benefits and serious adverse effects of mesh or graft reinforcement in vaginal prolapse surgery . FUNDING UK National Institute of Health Research OBJECTIVE Twin-twin transfusion syndrome ( TTTS ) is associated with significant mortality and morbidity . Potential treatments for the condition require robust evaluation . The aim of this study was to evaluate outcome reporting across observational studies and r and omized controlled trials assessing treatments for TTTS . METHODS Cochrane Central Register of Controlled Trials , EMBASE and MEDLINE were search ed from inception to August 2016 . Observational studies and r and omized controlled trials reporting outcome following treatment for TTTS  in monochorionic-diamniotic twin pregnancy and monochorionic-triamniotic or dichorionic-triamniotic triplet pregnancy were included . Outcome reporting was systematic ally extracted and categorized . RESULTS Six r and omized trials and 94 observational studies were included , reporting data from 20 071 maternal participants and 3199 children . Six different treatments were evaluated . Included studies reported 62 different outcomes , including six fetal , seven offspring mortality , 25 neonatal , six early childhood and 18 maternal/operative outcomes . Outcomes were reported inconsistently across trials . For example , when considering offspring mortality , 31 ( 31 % ) studies reported live birth , 31 ( 31 % ) reported intrauterine death , 49 ( 49 % ) reported neonatal mortality and 17 ( 17 % ) reported perinatal mortality . Four ( 4 % ) studies reported respiratory distress syndrome . Only 19 ( 19 % ) studies were design ed for long-term follow-up and 11 ( 11 % ) of these reported cerebral palsy . CONCLUSIONS Studies evaluating treatments for TTTS have often neglected to report clinical ly important outcomes , especially neonatal morbidity outcomes , and most are not design ed for long-term follow-up . The development of a core outcome set could help st and ardize outcome collection and reporting in TTTS studies . Copyright © 2018 ISUOG . Published by John Wiley & Sons PURPOSE We compared the efficacy and safety of anterior colporrhaphy with transvaginal polypropylene mesh insertion for anterior vaginal wall prolapse at medium term followup . MATERIAL S AND METHODS In this prospect i ve , r and omized , controlled trial 100 women with stage II or greater anterior vaginal wall prolapse assessed by POP-Q were r and omized to anterior colporrhaphy ( controls ) or mesh insertion . Anatomical outcomes were assessed by POP-Q measurement and prolapse stage . Subjective outcomes and quality of life impact were evaluated by ICIQ question naires . We evaluated the procedure safety profile according to intraoperative complication rates throughout followup . RESULTS In the mesh and control  groups 42 and 50 women completed the 24-month followup . Point Ba did not significantly differ between the groups at baseline but at 24-month followup it had significantly improved in the mesh group compared to controls . However , no difference was found between the groups when considering 2 cure criteria on prolapse stage and subjective parameters . Asymptomatic mesh exposure developed on the anterior vaginal wall prolapse in 7 patients ( 16.4 % ) in the mesh group . Minor mesh related complications consisted of mesh exposure , prepubic ecchymosis and groin pain , of which most were treated conservatively . Urinary retention was treated surgically . CONCLUSIONS Nazca TC ™ and anterior colporrhaphy provided good overall anatomical outcomes during a minimum 24-month followup . Vaginal and urinary symptoms , and quality of life improved postoperatively in each group . From the patient perspective Nazca TC did not show superior overall outcomes compared to anterior colporrhaphy performed with or without a retropubic sling OBJECTIVE : To compare anatomical and patient-reported outcomes at 12 months postoperatively for women who had anterior compartment pelvic organ prolapse ( POP ) surgery using a repair augmented with porcine small intestine submucosa mesh ( Mesh Group ) compared with those who had a native tissue repair ( No Mesh Group ) . METHODS : This was a r and omized controlled trial with 12 months follow-up . The surgical procedure was identical in both groups except for the placement of intervening mesh . The primary outcome was anatomical “ cure ” ( Ba of −1 or less on Pelvic Organ Prolapse Quantification [ POP-Q ] ) . Secondary outcomes included POP-Q stage , patient-reported outcomes , and patient satisfaction . The study was powered to detect a 40 % difference at 80 % power ( & agr;=0.05 ) . RESULTS : Fifty-seven women were r and omized ( 28 to Mesh Group , 29 to No Mesh Group ) . Forty-five ( 79 % ) underwent concomitant surgery . At the 12-month follow-up , 56 % ( 15/27 ) in the Mesh Group and 61 % ( 17/28 ) in the No Mesh Group were considered cured ( relative risk 0.90 , 95 % confidence interval 0.52–1.54 ) . There were no significant differences between groups in recurrent or persistent prolapse ( 7 % in each group ) nor in patient-reported outcomes at 12 months . Pelvic girdle pain occurred in 4 of 27 in the Mesh Group and 3 of 28 in the No Mesh Group . CONCLUSION : No significant differences were observed in anatomical or patient-reported outcomes outcome parameters at 12 months after correction of symptomatic anterior POP by mesh or no mesh repair . In our study , porcine small intestine submucosa mesh did not confer additional benefit over a native tissue repair . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT0095544 . LEVEL OF EVEDIENCE : OBJECTIVE The purpose of this study was to compare 2 anti-incontinence procedures in women who had severe genital prolapse and potential stress incontinence . STUDY DESIGN In addition to vaginal reconstructive surgery , 50 patients with stage II or higher anterior defect and a positive stress test result with prolapse reduction received either tension-free vaginal tape or plication of the endopelvic fascia . Preoperative evaluation included history , physical examination , stress test , and urodynamic assessment . Data were analyzed with the Student t test , the Fisher 's exact test , and the Wilcoxon signed-rank test . RESULTS The median follow-up time was similar for both groups , 26 and 24 months . Subjective ( 96 % vs 64 % ; P=.01 ) and objective ( 92 % vs 56 % ; P<.01 ) continence rates were higher after the tension-free vaginal tape procedure . Time for the resumption of spontaneous voiding , rates of urinary retention , or de novo urge incontinence were similar in the 2 groups . CONCLUSION Tension-free vaginal tape can be recommended for patients with prolapse and occult stress incontinence Introduction and hypothesisTo compare the efficacy of a collagen-coated polypropylene mesh and anterior colporrhaphy in the treatment of stage 2 or more anterior vaginal wall prolapse . Methods Prospect i ve , r and omized , multicenter study conducted between April 2005 and December 2009 . The principal endpoint was the recurrence rate of stage 2 or more anterior vaginal wall prolapse 12 months after surgery . Secondary endpoints consisted of functional results and mesh-related morbidity . Results One hundred and forty-seven patients were included , r and omized and analyzed : 72 in the anterior colporrhaphy group and 75 in the mesh group .  The anatomical success rate was significantly higher in the mesh group ( 89 % ) than in the colporrhaphy group ( 64 % ) ( p = 0.0006 ) . Anatomical and functional recurrence was also less frequent in the mesh group ( 31.3 % vs 52.2 % , p = 0.007 ) . Two patients ( 2.8 % ) were reoperated on in the colporrhaphy group for anterior vaginal wall prolapse recurrence . No significant difference was noted regarding minor complications . An erosion rate of 9.5 % was noted . De novo dyspareunia occurred in 1/14 patients in the colporrhaphy group and in 3/13 patients in the mesh group . An analysis of the quality of life question naires showed an overall improvement in both groups , with no statistical difference between them . Satisfaction rates were high in both groups ( 92 % in the colporrhaphy group and 96 % in the mesh group ) . Conclusion Trans-obturator Ugytex ® mesh used to treat anterior vaginal wall prolapse gives better 1-year anatomical results than traditional anterior colporrhaphy , but with small a increase in morbidity in the mesh group Introduction and hypothesisThis trial aim ed to compare the outcomes of native vaginal tissue repair versus polypropylene mesh repair for the treatment of severe genital prolapse . Methods This multicenter r and omized trial included 184 women , with POP-Q stage 3 or 4 . They were r and omly assigned to undergo surgical treatment using native tissue repair ( n = 90 ) or synthetic mesh repair ( n = 94 ) . Native tissue repair surgery was performed according to site-specific defects , including sacrospinous ligament fixation for apical defects . Mesh repair ( Prolift ™ ) was performed in accordance with manufacturer recommendations . Hysterectomy was performed in all cases of uterine prolapse . Statistical tests were used to compare between-group and within-group differences before the surgery and at 1-year follow-up . We considered cure to have occurred when the POP-Q point evaluation was equal to or less than 0 and POP-Q point C better than or equal to half the total vaginal length ( TVL ) after 1 year . The patients answered the Prolapse Quality -of-Life Question naire ( PQoL ) and the Sexual Quotient Female Version ( QS-F ) question naire . Results Both groups were homogeneous preoperatively . There were no differences between the groups in operative time , complications or pain . At 1-year follow-up , anatomical cure rates were better in the mesh group in the anterior compartment ( p = 0.019 ) . Significant improvement in PQoL scores at 1-year follow up were observed in each group ; between-group comparisons of changes in PQoL scores revealed greater improvement in the mesh group . Conclusion Both techniques were effective . Anatomical efficacy was superior in the mesh group regarding the anterior compartment ; quality of life changes were also greater in the mesh  group . Complications were significantly higher in the mesh group Introduction and hypothesisThe aim of the study was to compare the efficacy and safety of transvaginal trocar-guided polypropylene mesh insertion with traditional colporrhaphy for treatment of anterior vaginal wall prolapse . Methods This is a r and omized controlled trial in which women with advanced anterior vaginal wall prolapse , at least stage II with Ba ≥ + 1 cm according to the Pelvic Organ Prolapse Quantification ( POP-Q ) classification , were r and omly assigned to have either anterior colporrhaphy ( n = 39 ) or repair using trocar-guided transvaginal mesh ( n = 40 ) . The primary outcome was objective cure rate of the anterior compartment ( point Ba ) assessed at the 12-month follow-up visit , with stages 0 and I defined as anatomical success . Secondary outcomes included quantification of other vaginal compartments ( POP-Q points ) , comparison of quality of life by the prolapse quality of life ( P-QOL ) question naire , and complication rate between the groups after 1 year . Study power was fixed as 80 % with 5 % cutoff point ( p < 0.05 ) for statistical significance . Results The groups were similar regarding demographic and clinical preoperative parameters . Anatomical success rates for colporrhaphy and repair with mesh placement groups were 56.4 vs 82.5 % ( 95 % confidence interval 0.068–0.54 ) , respectively , and the difference between the groups was statistically significant ( p = 0.018 ) . Similar total complication rates were observed in both groups , with tape exposure observed in 5 % of the patients . There was a significant improvement in all P-QOL domains as a result of both procedures ( p < 0.001 ) , but they were not distinct between groups ( p > 0.05 ) . Conclusions Trocar-guided transvaginal synthetic mesh for advanced anterior POP repair is associated with a higher anatomical success rate for the anterior compartment compared with traditional colporrhaphy . Quality of life equally improved after both techniques . However , the trial failed to detect differences in P-QOL scores and complication rates between the groups AIMS To compare efficacy and safety of the traditional colporraphy and transvaginal polypropylene mesh for the treatment of advanced anterior vaginal prolapse according to different success criteria in two-year follow-up . METHODS In this r and omized controlled trial , women with anterior prolapse stage II or greater , with Ba point ≥ + 1 ( POP-Q quantification ) , were r and omly assigned to have either anterior colporraphy ( n = 43 ) or transvaginal mesh repair ( n = 43 ) . The primary outcome was to compare objective success rate under two success definitions : prolapse stage I ( Ba < -1 ) and stage II ( Ba < 0 ) . Secondary outcomes included complications and prolapse symptoms , satisfaction and quality of life ( QoL ) . Intention to treat was used for the primary endpoint and per protocol analysis for the secondary outcomes . RESULTS The groups presented similar preoperative data . Thirty three patients from the colporraphy and 37 from the mesh groups completed two-year follow-up . Under Ba < -1 definition , success rate was 39.53 % for both groups ( P = 1.00 ) . Considering success as Ba < 0 , analysis favored the mesh group by 23 % ( 51.16 % and 74.42 % ; 95 % CI for difference : 3 - 43 % ; P = 0.022 ) . Patients from the mesh group were more satisfied after two years ( 81.8 % and 97.3 % for colporraphy and mesh , respectively , 15.5 % difference ; 95 % CI for difference 1 - 29 % ; P = 0.032 ) . Both procedures similarly improved women 's symptoms and QoL. Some complications were observed , one being a 13.5 % mesh exposure rate . CONCLUSIONS Transvaginal synthetic mesh repair for advanced anterior vaginal prolapse provided higher anatomical success and satisfaction rates compared with traditional colporraphy . Both procedures equally improved quality of life . Neurourol . Urodynam . 35:509 - 514 , 2016 . © 2015 Wiley Periodicals , Introduction and hypothesisThe optimal duration of urethral catheterization during and after pelvic reconstructive surgery is not established . This study investigated the optimal duration of urinary catheterization in patients undergoing anterior vaginal repair with or without other vaginal surgeries . Methods A total of 90 patients were included from April 2007 to March 2008 . They were r and omly divided into 2 , 3 , and 4 days urinary catheterization groups based on the color of the question naire papers they blindly chose . After catheter removal , the amount of post-void residual urine was used to measure the efficacy of bladder emptying . Differences between groups were determined using Chi-square test , Fisher 's exact test , or Kruskal – Wallis test , as appropriate . Results No significant differences were found in the amount of post-void residual urine between the three catheterization groups . Conclusions Our findings suggest that the duration of  urethral catheterization  after anterior colporrhaphy need not exceed 2 days OBJECTIVE To compare the use of polypropylene mesh ( PM ) and the traditional anterior vaginal wall colporraphy in women with anterior vaginal wall prolapse ( AVWP ) using objective and subjective tests and evaluation of quality of life ( QoL ) . MATERIAL S AND METHODS One hundred women were r and omly distributed in two preoperatory groups . The first group ( mesh ) ( n = 45 ) received a PM implant and the control group ( n = 55 ) was su bmi tted to traditional colporraphy . Postoperatory follow-up was done after 12 months . The primary objective was the correction of the Ba point ≤ -2 POP-Q ( Pelvic Organ Prolapse Quantification System ) and the secondary objective was the improvement of vaginal symptoms and QoL through ICIQ-VS ( International Consultation on Incontinence Question naire - Vaginal Symptoms ) . Complications related to the use of PM or not were also described . RESULTS There was a significant difference between all POP-Q measures of pre- and postoperatory periods of each group in particular . There was a significant difference of the Ba point of the postoperatory period between the Mesh and Control group . The mean of Ba point in the Mesh group was statistically lower than of the Control group , depicting the better anatomical result of the first group . Both techniques improved vaginal symptoms and QoL. The most frequent complication of the Mesh group was prepubic hematoma in the perioperative period . In 9.3 % of the cases treated with mesh it was observed PM exposition at the anterior vaginal wall after 12 months , being most of them treated clinical ly . CONCLUSION The treatment of AVWP significantly improved the Ba point in the Mesh group in comparison to the Control group . There were no differences of the vaginal symptoms and QoL between the two groups after 12 months . There were few and low grade complications on both groups The aim of this study was to compare the efficiency of polypropylene mesh surgery with the site-specific repair surgeries in the treatment of cystocoeles . We r and omized 90 patients into two groups according to a computer-based program . After a 12-month ( mean ) follow up , we noticed that the polypropylene mesh surgery yielded good anatomical results . Acceptable anatomical cure rates were 91 and 72 % in the mesh surgery group and site-specific surgery group , respectively . There were three cases ( 6.9 % ) of mesh erosion . One case of urinary retention and two cases of de novo dyspareunia were seen in the mesh surgery  group . De novo stress urinary incontinence developed in three patients in the site-specific surgery group . We concluded that surgery with light polypropylene mesh ( Sofradim ® , Parietene ) is superior to the site-specific surgery in the treatment of cystocoeles Introduction and hypothesisFor prolonged catheterization after vaginal prolapse surgery with anterior colporrhaphy  , the optimal duration to prevent overdistention of the bladder remains unknown . We design ed this study to determine the optimal length of catheterization . Methods We conducted a prospect i ve r and omized trial in which 179 women were allocated to 1-day or 3-day suprapubic catheterization .  The primary outcome was the duration of catheterization . Results Mean duration of catheterization and hospital stay was significantly shorter in the 1-day catheterization group . The number of successful voiding trials was higher in the 3-day catheterization group ( 90.9 % versus 79.3 % ) , but this did not reach statistical significance . The percentage of urinary tract infection did not differ significantly between the groups ( 4.5 % versus 2.4 % ) . ConclusionS tarting a voiding trial 1 day after vaginal prolapse surgery leads to shorter duration of catheterization and hospital stay We compared safety and efficacy of Gynemesh PS ® and Pelvicol ® for recurrent cystocele repair . One hundred ninety patients were r and omly divided into Gynemesh PS ® and Pelvicol ® groups and underwent tension-free cystocele repair . The Chi-square test was used to compare categorical variables , the paired t test for continuous parametric variables , and the Mann – Whitney test for continuous nonparametric variables . Ninety-six Gynemesh PS ® patients and 94 Pelvicol ® patients were studied . Mesh erosions occurred in 6.3 % of Gynemesh PS ® patients . No erosions were observed in Pelvicol ® patients ( p = 0.02 ) . Objective cure was 71.9 % for Gynemesh PS ® and 56.4 % for Pelvicol ® ( p = 0.06 ) . Subjective cure was the same in both groups except for better sexuality in the Pelvicol ® group . At 24 months follow-up , only Gynemesh PS ® patients had mesh erosions . Anatomical outcome was similar in the two groups . Pelvicol ® gave a better impact on voiding and sexuality OBJECTIVE : To present 3-month outcomes of a double-blind , multicenter r and omized controlled trial comparing traditional vaginal prolapse surgery without mesh with vaginal surgery with mesh . METHODS : Women with pelvic organ prolapse quantification prolapse stages 2–4 were r and omized to vaginal colpopexy repair with mesh or traditional vaginal colpopexy without mesh . The primary outcome measure was objective treatment success ( pelvic organ prolapse quantification stage 1 or lower ) at 3 months . Secondary outcome measures included quality -of-life variables and complication rates . RESULTS : Sixty-five women were recruited from January 2007 to August 2009 , when the study was halted due to predetermined stopping criteria for vaginal mesh erosion at a median follow-up of 9.7 months ( range , 2.4–26.7 months ) . Thirty-two women underwent mesh colpopexy  ( 24 anterior mesh , eight total mesh ) , and 33 women had vaginal colpopexies without mesh  ( primarily uterosacral ligament suspension ) and concurrent colporrhaphy . There were no statistically significant baseline differences between the mesh and no-mesh groups with respect to demographics , menopausal status , and race . Analysis of the mesh and no-mesh women found no difference with respect to overall recurrence ( mesh : 19 [ 59.4 % ] compared with no mesh : 24 [ 70.4 % ] , P=.28 ) . There were five ( 15.6 % ) vaginal mesh erosions . Two cystotomies and one blood transfusion occurred in the mesh group only . Subjective cure of bulge symptoms was noted in 93.3 % of mesh patients and 100 % of no-mesh patients . Furthermore , subjective quality -of-life measurements did not differ between the two groups at baseline or 3 months postoperatively . CONCLUSION : At 3 months , there is a high vaginal mesh erosion rate ( 15.6 % ) with no difference in overall objective and subjective cure rates . This study questions the value of additive synthetic polypropylene mesh for vaginal prolapse repairs . CLINICAL TRIAL REGISTRATION : Clinical trials.gov , www . clinical trials.gov , NCT00475540 . LEVEL OF EVIDENCE : INTRODUCTION Surgical treatment of pelvic organ prolapse ( POP ) affects sexual function . Generally , this results in improved sexual function , but deterioration is reported also . AIM The purpose of this study was to evaluate and compare sexual function in patients with recurrent POP undergoing either a vaginal surgical repair with native tissue or a trocar-guided mesh insertion .  METHODS Sexually active patients r and omly assigned to either native tissue repair or trocar-guided mesh insertion  , which had completed the pelvic organ prolapse (POP)/urinary incontinence sexual question naire ( PISQ-12 ) both at baseline and at 12 months , were included . Total , subscale , and individual question analysis were performed . Logistic regression was used to identify factors that were independently associated with improvement/deterioration in total PISQ-12 scores . MAIN OUTCOME MEASURES Primary outcome was sexual function at 12 months following surgery , measured by the short form of the pelvic organ prolapse/urinary incontinence sexual question naire ( PISQ-12 ) . Secondary outcomes were the identification of factors independently associated with change in PISQ-12 scores and changes in individual PISQ-12 question scores . RESULTS Sixty patients were included ; 32 in the mesh arm and 28 in the native tissue arm . At 12 months , PISQ-12 scores were not different in both treatment arms ( 34.3 , st and ard deviation [ SD ] 6.7 vs. 34.7 , SD 5.7 ) , but improvement was detected in the native tissue arm , whereas PISQ-12 total score remained unchanged in the mesh arm . Deteriorations were observed in the behavioral/emotive subscale and partner-related items in the mesh arm . In the native tissue arm , significant improvements in the physical and partner-related subscales were observed . The presence of mesh exposure was independently associated with deterioration in total PISQ-12 score . CONCLUSION At 12 months , PISQ-12 scores were not different in either treatment arm , but were affected differently by trocar-guided mesh insertion or by native tissue repair . Mesh exposure was independently associated with deterioration in sexual function Introduction and hypothesisThe effect of a Pelvicol ® graft compared with a conventional anterior vaginal repair was evaluated in this r and omised controlled study . Methods Only patients with a stage II or higher ( Ba ≥ −1 ) defect were included . Results Thirty-one patients were allocated to a conventional anterior repair ; 30 to Pelvicol ® graft . At 12 months follow-up , four patients among controls ( 15 % ) and two in the graft group ( 7 % ) had objective recurrence . Among controls , the difference at 3 months follow-up in Ba was 6.0 cm when compared with the position of Ba prior to surgery . In the graft group , the difference was 7.0 cm ( P < 0.05 ) . This difference was still present at 12 months follow-up ( 6.0 vs. 7.0 cm ; P < 0.05 ) . Conclusions The implantation of a Pelvicol ® graft does not improve the POP-Q stage The purpose of this study is to compare the feasibility of local anesthesia with IV sedation versus general anesthesia for vaginal correction of pelvic organ prolapse . Patients with pelvic organ prolapse who were scheduled for an anterior or posterior colporrhaphy , or an obliterative procedure , and who did not have a contraindication or preference to type of anesthesia were r and omized to one of the two anesthesia groups . Nineteen patients were r and omized to the general group and 21 patients were r and omized to the local group .  Mean operating room , anesthesia , and surgical time were similar in each group , and 10 patients in the local group bypassed the recovery room . Requests and doses of antiemetics , postoperative verbal numerical pain scores and length of hospital stay were similar between the two groups . Mean recovery room and total hospital costs were significantly lower in the local group . Local anesthesia with IV sedation is a feasible alternative for vaginal surgery to correct pelvic organ prolapse To investigate the effect of prophylactic phenoxybenzamine on the bladder emptying after vaginal repair operations , 41 consecutive patients , who underwent the Manchester operation or an anterior + posterior repair because of genital descensus , were allocated at r and om to either prophylactic phenoxybenzamine ( PBZ-group ) or placebo treatment in the postoperative course . Prophylactic phenoxybenzamine was found to produce an improved emptying function of the bladder , leading to a statistically significant reduced number of acute urinary retentions ( P = 0.029 ) , decreased time until spontaneous voiding ( P = 0.026 ) and reduced volume of residual urine ( P = 0.018 ) . Furthermore , a reduced incidence of urinary tract infections was found in the PBZ-group . Prophylactic phenoxybenzamine treatment is recommended as an alternative to routine bladder drainage in preventing urinary retention following vaginal repair operations for genital descensus Introduction and hypothesisThe optimal surgery for lateral defects is not well defined . Our objective was to assess the effects of anterior trocar-guided transvaginal mesh repair versus anterior colporrhaphy in women with lateral defects . Methods This sub analysis from a r and omized controlled trial of mesh kit versus anterior colporrhaphy assessed 99 patient diagnosed at baseline with lateral defects in the anterior vaginal wall . Thirty-nine patients underwent anterior colporrhaphy and 60 anterior trocar-guided transvaginal mesh surgery .  Results One year after surgery , a persistent lateral defect was significantly more common after colporrhaphy compared with transvaginal mesh [ 11/32 ( 34.4 % ) vs 1/42 ( 2.4 % ) , risk ratio ( RR ) 14.4 , 95 % confidence interval ( CI ) 2.0–106.1 ; P < 0.001 ) ] However , there were no significant differences between treatment groups with regard to subjective symptoms as reflected by the overall Urogenital Distress Inventory scores , with mean difference from baseline 37.3 ± 50.6 in the colporrhaphy group vs 39.0 ± 45.8 in the mesh group ( p = 0.61 ) . Conclusions Use of a transvaginal mesh kit increases the odds for anatomical correction of lateral defects compared with anterior colporrhaphy but does not necessarily improve lower urinary tract symptoms Introduction and hypothesisThe aim of this study was to compare the number of temporary catheter replacements and urinary tract infections after  indwelling catheterization  for 2 versus 5 days following an anterior colporrhaphy . Methods Two hundred forty-six patients were r and omly assigned to 2 or 5 days of indwelling catheterization .  Outcome measures were temporary catheter replacements because of post-voiding residual > 200 mL after removal of the indwelling catheter , urinary tract infections , and hospital stay . All patients were analyzed according to the intention to treat principle . Results Compared to the 5-day protocol group , in the 2-day protocol group more patients needed temporary catheter replacement ( 9 % versus 28 % , odds ratio ( OR ) 4.0 , confidence interval ( CI ) 1.9–8.3 , p < 0.01 ) , whereas less patients had a urinary tract infection ( 37 % versus 22 % , OR 0.5 , CI 0.3–0.9 , p = 0.02 ) and median hospital stay was lower . Conclusions Removal of an indwelling catheter after 2 versus 5 days following anterior colporrhaphy is associated with more temporary catheter replacements , but less urinary tract infections and a shorter hospital stay BACKGROUND Pre-eclampsia is a serious complication of pregnancy and contributes to maternal and offspring mortality and morbidity . R and omised controlled trials evaluating therapeutic interventions for pre-eclampsia have reported many different outcomes and outcome measures . Such variation contributes to an inability to compare , contrast , and combine individual studies , limiting the usefulness of research to inform clinical practice . The development and use of a core outcome set would help to address these issues ensuring outcomes important to all stakeholders , including patients , will be collected and reported in a st and ardised fashion . METHODS An international steering group including healthcare professionals , research ers , and patients , has been formed to guide the development of this core outcome set . Potential outcomes will be identified through a comprehensive literature review and semi-structured interviews with patients . Potential core outcomes will be entered into an international , multi-perspective online Delphi survey . All key stakeholders , including healthcare professionals , research ers , and patients will be invited to participate . The modified Delphi method encourages whole and stakeholder group convergence towards consensus ' core ' outcomes . Once core outcomes have been agreed upon it is important to determine how they should be measured . The truth , discrimination , and feasibility assessment framework will assess the quality of potential outcome measures . High quality outcome measures will be associated with core outcomes . Mechanisms exist to disseminate and implement the result ing core outcome set within an international context . DISCUSSION Embedding the core outcome set within future clinical trials , systematic review s , and clinical practice guidelines could make a profound contribution to advancing the usefulness of research to inform clinical practice , enhance patient care , and improve maternal and offspring outcomes . The infrastructure created by developing a core outcome set for pre-eclampsia could be leveraged in other setting s , for example selecting research priorities and clinical practice guideline development . PROSPECT IVE REGISTRATION : [ 1 ] Core Outcome Measures in Effectiveness Trials ( COMET ) registration number : 588 . [ 2 ] International Prospect i ve Register of Systematic Review s ( PROSPERO ) registration number : CRD42015015529 OBJECTIVE : The aim of this study was to compare female sexual function after surgical treatment of anterior vaginal prolapse with either small intestine submucosa grafting or traditional colporrhaphy . METHODS : Subjects were r and omly assigned , preoperatively , to the  small intestine submucosa graft ( n = 29 ) or traditional colporrhaphy ( n = 27 ) treatment group . Postoperative outcomes were analyzed at 12 months . The Female Sexual Function Index question naire was used to assess sexual function . Data were compared with independent sample s or a paired Student 's t-test . Clinical Trials.gov : NCT00827528 . RESULTS : In the small intestine submucosa group , the total mean Female Sexual Function Index score increased from 15.5±7.2 to 24.4±7.5 ( p<0.001 ) . In the traditional colporrhaphy group , the total mean Female Sexual Function Index score increased from 15.3±6.8 to 24.2±7.0 ( p<0.001 ) . Improvements were noted in the domains of desire , arousal , lubrication , orgasm , satisfaction , and pain . There were no differences between the two groups at the 12-month follow-up . CONCLUSIONS : Small intestine submucosa repair and traditional colporrhaphy both improved sexual function postoperatively . However , no differences were observed between the two techniques Background Twin – Twin Transfusion Syndrome ( TTTS ) is associated with an increased risk of perinatal mortality and morbidity . Several treatment interventions have been described for TTTS , including fetoscopic laser surgery , amnioreduction , septostomy , expectant management , and pregnancy termination . Over the last decade , fetoscopic laser surgery has become the primary treatment . The literature to date reports on many different outcomes , making it difficult to compare results or combine data from individual studies , limiting the value of research to guide clinical practice . With the advent and ongoing development of new therapeutic techniques , this is more important than ever . The development and use of a core outcome set has been proposed to address these issues , prioritising outcomes important to the key stakeholders , including patients . We aim to produce , disseminate , and implement a core outcome set for TTTS . Methods An international steering group has been established to oversee the development of this core outcome set . This group includes healthcare professionals , research ers and patients . A systematic review is planned to identify previously reported outcomes following treatment for TTTS . Following completion , the identified outcomes will be evaluated by stakeholders using an international , multi-perspective online modified Delphi method to build consensus on core outcomes . This method encourages the participants towards consensus ‘ core ’ outcomes . All key stakeholders will be invited to participate . The steering group will then hold a consensus meeting to discuss results and form a core outcome set to be introduced and measured . Once core outcomes have been agreed , the next step will be to determine how they should be measured , disseminated , and implemented within an international context . Discussion The development , dissemination , and implementation of a core outcome set in TTTS will enable its use in future clinical trials , systematic review s and clinical practice guidelines . This is likely to advance the quality of research studies and their effective use in order to guide clinical practice and improve patient care , maternal , short-term perinatal outcomes and long-term neurodevelopmental outcomes .Trial registration Core Outcome Measures in Effectiveness Trials ( COMET ) , 921 Registered on July 2016.International Prospect i ve Register of Systematic Review s ( PROSPERO ) , CRD42016043999 . Registered on 2 August 2016 Introduction and hypothesisDifferent forms of urinary drainage are applied after  anterior colporrhaphy . Suprapubic urinary catheter ( SUC ) and indwelling urinary catheter ( IUC ) for 2 to 96 h are preferred . If there is no difference in symptomatic urinary tract infection ( SUTI ) or complications between IUCs for 96 and 24 h , the latter will be considered sufficient . If IUCs have no higher rate of infections or complications compared to SUC for 96 h , the former could be considered sufficient . Methods It was a three-arm prospect i ve , r and omized study including 257 patients . The three arms were : IUCs for 24 h , IUCs for 96 h , and SUCs for 96 h. Results We found no significant difference in SUTIs between all three groups . Although the SUC arm showed no SUTIs , a significant higher rate of complications was seen . Conclusion The optimal bladder catheter after anterior colporrhaphy was , in our trial , the IUC for 24 OBJECTIVE : To compare anterior colporrhaphy with and without a tailored mesh . METHODS : Postmenopausal women with anterior vaginal prolapse to the hymen or beyond were r and omly assigned to undergo traditional anterior colporrhaphy alone or reinforced with mesh . The low-weight monofilament polypropylene mesh was self-tailored , having four arms and being placed over the plicated fascia . Before and 2 and 12 months after surgery , participants were evaluated by physical examination , postvoidal residual urine measurement and st and ard questions covering prolapse-related symptoms . The primary outcome was recurrence of anterior vaginal prolapse at 12 months . Secondary outcomes included operative complications , symptom resolution , and postvoidal urine residual volume . RESULTS : Of the 202 women r and omly assigned , 201 were operated on ( 97 without , 104 with mesh ) . Thirty-seven women ( 38.5 % ) in the no-mesh and seven ( 6.7 % ) in the mesh group experienced a recurrence of anterior wall prolapse ( P<.001 ) at 12 months ; as a result , the number needed to treat for benefit was four . The mean ( st and ard deviation ) postvoidal residual urine volume was lower in patients with mesh than in those undergoing the traditional operation : 25 ( 26 ) mL and 41 ( 57 ) mL ( P=.01 ) . Twenty-three women ( 23 % ) with mesh and 9 ( 10 % ) with no mesh reported stress urinary incontinence ( P=.02 ) . In 18 ( 17.3 % ) , exposure of the mesh was noted , mainly asymptomatic . CONCLUSION : Anterior colporrhaphy , reinforced with , tailored mesh significantly reduced the rate of recurrence of anterior vaginal wall prolapse compared with the traditional operation , but was associated more often with stress urinary incontinence . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00420225 LEVEL OF EVIDENCE : OBJECTIVES Our purpose was to determine whether a vaginal or abdominal approach is more effective in correcting  uterovaginal prolapse .  STUDY DESIGN Eighty-eight women with cervical prolapse to or beyond the hymen or with vaginal vault inversion > 50 % of its length and anterior vaginal wall descent to or beyond the hymen were r and omized to a vaginal versus abdominal surgical approach .  Forty-eight women underwent a vaginal approach with bilateral sacrospinous vault suspension and paravaginal repair , and 40 women underwent an abdominal approach with colposacral suspension and paravaginal repair . Ancillary procedures were performed as indicated . Detailed pelvic examination was performed postoperatively by the nonsurgeon coauthor yearly up to 5 years . The women were examined while st and ing during maximum strain . Surgery was classified as optimally effective if the woman remained asymptomatic , the vaginal apex was supported above the levator plate , and no protrusion of any vaginal tissue beyond the hymen occurred . Surgical effectiveness was considered unsatisfactory if the woman was symptomatic , the apex descended > 50 % of its length , or the vaginal wall protruded beyond the hymen . RESULTS Eighty women ( vaginal 42 , abdominal 38 ) were available for evaluation at 1 to 5.5 years ( mean 2.5 years ) . The groups were similar in age , weight , parity , and estrogen status , and 56 % had undergone prior pelvic surgery . There was no significant difference between the groups in morbidity , complications , hemoglobin change , dyspareunia , pain , or hospital stay . The vaginal group had longer catheter use , more urinary tract infections , more incontinence , decreased operative time , and lower hospital charge . Surgical effectiveness was optimal in 29 % of the vaginal group and 58 % of the abdominal group and was unsatisfactory leading to reoperation in 33 % of the vaginal group and 16 % of the abdominal group . The reoperations included procedures for recurrent incontinence in 12 % of the vaginal and 2 % of the abdominal groups . The relative risk of optimal effectiveness by the abdominal route is 2.03 ( 95 % confidence interval 1.22 to 9.83 ) , and the relative risk of unsatisfactory outcome using the vaginal route is 2.11 ( 95 % confidence interval 0.90 to 4.94 ) . CONCLUSIONS Reconstructive pelvic surgery for correction of significant pelvic support defects was more effective with an abdominal approach OBJECTIVE : To compare surgeons ' intraoperative surgeon acceptability or assessment of the operative field regarding bowel contents and patients ' satisfaction with or without a mechanical bowel preparation before reconstructive vaginal prolapse surgery . METHODS : In this single-blind , r and omized trial , women scheduled to undergo vaginal prolapse surgery with a planned apical suspension and posterior colporrhaphy were allocated using block r and omization to an intervention or control group . Surgeons were blinded to patient allocation . One day before surgery , mechanical bowel preparation instructions consisted of a clear liquid diet and two self-administered saline enemas ; the participants in the control group sustained a regular diet and nothing by mouth after midnight . The primary outcome was surgeons ' intraoperative assessment of the surgical field regarding bowel content as measured on a 4-point Likert scale ( 1 , excellent ; 4 , poor ) . Secondary outcomes included participant satisfaction and bowel symptoms . The primary outcome was determined by intention-to-treat analysis and other analyses were per protocol . RESULTS : Of the 150 women r and omized ( 75 women to intervention and control group ) , 145 completed the study . No differences existed in the demographic , clinical , and intraoperative characteristics between groups ( P>.05 ) . Surgeons ' intraoperative assessment rating was 85 % “ excellent or good ” with bowel preparation compared with 90 % for participants in the control group ( odds ratio [ OR ] 0.59 , 95 % confidence interval [ CI ] 0.21–1.61 ; P=.30 ) . The bowel preparation group was less likely to report “ complete ” satisfaction compared with the participants in the control group ( OR 0.11 , 95 % CI 0.04–0.35 ; P<.001 ) . Abdominal fullness and cramping , fatigue , anal irritation , and hunger pains were greater in the bowel preparation group ( all P<.01 ) . CONCLUSION : Before reconstructive vaginal surgery , mechanical bowel preparation conferred no benefit regarding surgeons ' intraoperative assessment of the operative field , reflected decreased patient satisfaction , and had increased abdominal symptoms . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT01431040 . LEVEL OF EVIDENCE : Introduction We set out to determine if insertion of a retropubic tension-free vaginal tape ( TVT ) sling at the time of pelvic organ prolapse surgery improves continence outcomes in women with pre-operative occult stress incontinence ( OSI ) or asymptomatic urodynamic stress incontinence ( USI ) . Methods We conducted a r and omised controlled study of prolapse surgery with or without a TVT midurethral sling . The pre- and post-operative assessment at 6 months included history , physical examination and urodynamic testing . Quality of life ( QOL ) and treatment success was assessed with the UDI-6 SF , IIQ-7 SF and a numerical success score . The primary outcome was symptomatic stress urinary incontinence ( SUI ) requiring continence surgery ( TVT ) at 6 months . Long-term follow-up continued to a minimum of 24 months . Secondary outcomes were quality of life parameters . Results Eighty women received prolapse surgery alone ( n = 43 ) or prolapse surgery with concurrent TVT ( n = 37 ) . Six months following prolapse surgery 3 out of 43 ( 7 % ) patients in the no TVT group requested sling surgery compared with 0 out of 37 ( 0 % ) in the TVT group ( ARR 7 % [ 95 % CI : 3 to 19 % ] , p = 0.11 ) . After 24 months there was one further participant in the no TVT group who received a TVT for treatment of SUI compared with none in the TVT group ( 4 out of 43 , 9.3 % versus 0 out of 37 ; ARR 9.3 % [ 95 % CI : −1 to 22 % ] , p = 0.06 ) . Both groups showed improvement in QOL difference scores for within-group analysis , without difference between groups . Conclusion These results support a policy that routine insertion of a sling in women with OSI at the time of prolapse repair is question able and should be subject to shared decision-making between clinician and patient Please cite this paper as : Vollebregt A , Fischer K , Gietelink D , van der Vaart C. Primary surgical repair of anterior vaginal prolapse : a r and omised trial comparing anatomical and functional outcome between anterior colporrhaphy and trocar‐guided transobturator anterior mesh . BJOG 2011;118:1518–1527 Introduction and hypothesisHydrodissection incorporating different types of vasoconstrictors is commonly used in vaginal prolapse surgery . There is little evidence as to whether it adds clinical value or whether it exposes the patient to unnecessary risk . The aim of this study was to compare the effect of a vasoconstrictor compared with saline alone on operative blood loss and cardiovascular parameters in a r and omised clinical trial setting . Methods Patients undergoing vaginal prolapse surgery were r and omised to an ornipressin ( Por-8 , Ferring ) solution or saline alone for hydrodissection . The surgeon and patient were blinded to the solution used . Operative blood loss was accurately quantified and blood pressure and pulse readings recorded Pre , intra- and postoperatively . Results Eighty women were r and omised . There was a statistically significant difference in the median blood loss : 35 ml ( 1 - 209 ml ) in the ornipressin group compared with 81 ml ( 2 - 328 ml ) in the saline group , p = 0.03 . There was no statistically significant difference in the median pre and postoperative blood pressure or pulse rate between groups . Conclusions The use of a vasoconstrictor ( ornipressin ) result ed in a statistically significant decrease in operative blood loss during vaginal prolapse surgery . This occurred without any significant changes in measured cardiovascular parameters BACKGROUND The use of st and ardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years , but it is unclear whether this approach results in better outcomes than traditional colporrhaphy . METHODS In this multicenter , parallel-group , r and omized , controlled trial , we compared the use of a trocar-guided , transvaginal polypropylene-mesh repair kit with traditional colporrhaphy in women with prolapse of the anterior vaginal wall ( cystocele ) . The primary outcome was a composite of the objective anatomical design ation of stage 0 ( no prolapse ) or 1 ( position of the anterior vaginal wall more than 1 cm above the hymen ) , according to the Pelvic Organ Prolapse Quantification system , and the subjective absence of symptoms of vaginal bulging 12 months after the surgery . RESULTS Of 389 women who were r and omly assigned to a study treatment , 200 underwent prolapse repair with the transvaginal mesh kit and 189 underwent traditional colporrhaphy .  At 1 year , the primary outcome was significantly more common in the women treated with transvaginal mesh repair ( 60.8 % ) than in those who underwent colporrhaphy ( 34.5 % ) ( absolute difference , 26.3 percentage points ; 95 % confidence interval , 15.6 to 37.0 ) . The surgery lasted longer and the rates of intraoperative hemorrhage were higher in the mesh-repair group than in the colporrhaphy group ( P<0.001 for both comparisons ) . Rates of bladder perforation were 3.5 % in the mesh-repair group and 0.5 % in the colporrhaphy group ( P=0.07 ) , and the respective rates of new stress urinary incontinence after surgery were 12.3 % and 6.3 % ( P=0.05 ) . Surgical reintervention to correct mesh exposure during follow-up occurred in 3.2 % of 186 patients in the mesh-repair group . CONCLUSIONS As compared with anterior colporrhaphy , use of a st and ardized , trocar-guided mesh kit for cystocele repair result ed in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events . ( Funded by the Karolinska Institutet and Ethicon ; Clinical Trials.gov number , NCT00566917 . ) Purpose To compare the clinical effectiveness of anterior colporrhaphy versus mesh repair as surgical management of  anterior vaginal prolapse .  Methods Of 50 patients with ≥stage II anterior vaginal prolapse on Pelvic Organ Prolapse Quantification ( POPQ ) system who were initially approached , 44 consented and underwent surgery . They were r and omly recruited into two groups . Group I ( 23 patients ) received anterior colporrhaphy , while group II ( 21 patients ) received soft polypropylene mesh ( GYNEMESH*PS , Gynecare , Ethicon , France ) . Clinical assessment took place preoperatively and postoperatively at definite intervals . Functional and anatomical comparisons were based on comparison between preoperative and 24 months postoperative assessment s of symptoms and POPQ stages , respectively . Four patients in total did not complete the follow-up assessment s and were excluded . Results Both groups showed clinical improvement in their symptoms and POPQ staging at the end of the postoperative follow-up period . Improvement , however , was more significant in the repair with mesh group , as patients in this group reported better improvement of their prolapse symptoms , mainly vaginal bulge/pressure sensation ( P < 0.05 ) , and showed better improvement in the anatomical staging , individual POP-Q points Aa and Ba ( P < 0.01 ) , than the anterior colporrhaphy group . Group II also showed more satisfactory outcome with the general POP-Q staging ( P < 0.05 ) than group I , reflecting a better quality of life of the patients in the repair with mesh group . Conclusion Our data shows that repair with mesh is superior to anterior colporrhaphy with more satisfactory outcome to the patients . Due to the small size of our study and uncertainty of the long-term safety and resilience of the mesh , we recommend larger studies to confirm our preliminary results INTRODUCTION In pelvic organ prolapse ( POP ) repair , the use of synthetic mesh is not only increasing but also a subject of discussion . The focus shifts from anatomical toward functional outcome , with sexual function being an important parameter . One of the concerns with mesh usage in POP surgery is the possible negative effect on sexual function . AIM To compare and assess sexual function  in women and men after primary cystocele repair with or without trocar-guided transobturator mesh . METHODS One hundred twenty-five women with a symptomatic cystocele stage ≥ II were included in this multicenter r and omized controlled trial and assessed at baseline and 6-month follow-up . MAIN OUTCOME MEASURES Female sexual function was measured by the Female Sexual Function Index ( FSFI ) and male sexual function by the Male Sexual Health Question naire . A subgroup analysis of women with a participating partner was performed . RESULTS In the mesh group , 54/59 women vs. 53/62 in the anterior colporrhaphy group participated . In men , 29 vs. 30 participated . After surgery , FSFI scores were comparable for both treatment groups . However , within group analysis showed significant improvement on the domains pain ( effect size = 0.5 ) , lubrication ( effect size = 0.4 ) , and overall satisfaction ( effect size = 0.5 ) in the colporrhaphy group . This improvement was not observed in the mesh group . A subgroup of women with a participating partner reported significantly higher baseline domain scores as compared with other women and did not report a significant improvement of sexual functioning irrespective of treatment allocation . Worsening of baseline sexual function was reported by 43 % of women in the mesh group compared with 18 % in anterior colporrhaphy group ( P = 0.05 ) . Male sexual functioning did not change in either group . CONCLUSIONS Women after an anterior colporrhaphy report a significant and clinical ly relevant improvement of their sexual functioning , whereas women after a mesh procedure did not Introduction and hypothesisThe objective of this study was to evaluate the effect of vaginal packing following pelvic floor surgery with regard to post-operative pain , bleeding and infection . This was a double-blind r and omised study of women undergoing vaginal hysterectomy and /or pelvic floor repair at a tertiary urogynaecology unit . Methods The primary outcome of day 1 post-operative pain was assessed using the short-form McGill Pain score . Secondary outcomes were haematological and infective morbidity , evaluated using changes in full blood count , and cultures of midstream urine and high vaginal swabs . A transvaginal ultrasound scan to exclude pelvic haematoma was performed at 6 weeks in all women who underwent vaginal hysterectomy with or without a pelvic floor repair .  Results In total , 190 women were recruited : mean age 58.3 years ( 27–91 years ) , mean body mass index 27.4 kg/m2 and median parity 3 . Women were r and omised into the ‘ pack ’ ( n = 86 ) and ‘ no pack ’ ( n = 87 ) arms with no demographic differences between the groups . No statistically significant differences in the post-operative pain scores or secondary outcome measures were demonstrated . Incidence of haematoma formation ( 14.8 % no pack , 7.3 % pack , p = 0.204 ) was not statistically significant . There were three clinical ly significant complications in the no pack group and none in the pack group . Conclusions This is the first study to examine pain in association with post-operative vaginal packing . There is no evidence to suggest that packing increases pain scores or post-operative morbidity . A trend towards increased haematoma and significant complications was seen in the no pack group . As vaginal packing does no harm and may be of some benefit it may be argued that packing should be recommended as routine clinical practice Introduction and hypothesisWe compared pelvic organ prolapse ( POP ) repair with and without midurethral sling ( MUS ) in women with occult stress urinary incontinence ( SUI ) . Methods This was a r and omized trial conducted by a consortium of 13 teaching hospitals assessing a parallel cohort of continent women with symptomatic stage II or greater POP . Women with occult SUI were r and omly assigned to vaginal prolapse repair with or without MUS .  Women without occult SUI received POP surgery . Main outcomes were the absence of SUI at the 12-month follow-up based on the Urogenital Distress Inventory and the need for additional treatment for SUI . Results We evaluated 231 women , of whom 91 r and omized as follows : 43 to POP surgery with and 47 without MUS .  A greater number of women in the MUS group reported absence of SUI [ 86 % vs. 48 % ; relative risk ( RR ) 1.79 ; 95 % confidence interval ( CI ) 1.29–2.48 ] . No women in the MUS group received additional treatment for postoperative SUI ; six ( 13 % ) in the control group had a secondary MUS . Women with occult SUI reported more urinary symptoms after POP surgery and more often underwent treatment for postoperative SUI than women without occult SUI . Conclusions Women with occult SUI had a higher risk of reporting SUI after POP surgery compared with women without occult SUI . Adding a MUS to POP surgery reduced the risk of postoperative SUI and the need for its treatment in women with occult SUI . Of women with occult SUI undergoing POP-only surgery , 13 % needed additional  MUS . We found no differences in global impression of improvement and quality of life STUDY OBJECTIVE To compare the effectiveness and safety of 2 anterior transobturator mesh methods for treating anterior vaginal wall prolapse . DESIGN R and omized controlled study ( Canadian Task Force classification I ) . SETTING University hospital . PATIENTS Eighty-seven women with anterior vaginal wall prolapse stage ≥2 ( Pelvic Organ Prolapse Quantification [ POP-Q ] ) underwent an anterior transobturator mesh procedure using macropore polypropylene mesh . INTERVENTIONS Forty-five patients underwent the operation via the conventional 4-point , full-sized mesh method , and 42 patients underwent the operation via a novel 2-point , half-sized mesh method . MEASUREMENTS AND MAIN RESULTS Patient characteristics were comparable between the 2 groups . The anatomic cure rate was significantly lower in the 2-point group compared with the 4-point group at 12 months after surgery ( 87.2 % vs 100 % ; p = .03 ) . Healing abnormalities were significantly higher in the 2-point group than in the 4-point group ( 12.8 % vs 0 % ; p = .03 ) . Bladder perforation ( 2.6 % vs 0 % ) , stress urinary incontinence ( 23.1 % vs 22.5 % ) , urinary frequency ( 12.8 % vs 22.5 % ) , and voiding difficulty and dyspareunia ( 0 % vs 0 % ) were not statistically different between the 2 groups . At linear regression analysis , mean ( SD ) operation time did not differ between the 2 groups ( 74.9 [ 32.7 ] minutes vs 87.8 [ 36.7 ] minutes ; p = .11 ) . CONCLUSION Compared with the 4-point method , the 2-point anterior transobturator mesh method result ed in a lower rate of anatomic cure and a higher rate of healing abnormality Please cite this paper as : Withagen M , Milani A , de Leeuw J , Vierhout M. Development of de novo prolapse in untreated vaginal compartments after prolapse repair with and without mesh :  a secondary analysis of a r and omised controlled trial . BJOG 2012;119:354–360 OBJECTIVE The purpose of this study was to compare outcomes after anterior colporrhaphy with the use of 3 different surgical techniques . STUDY DESIGN One hundred fourteen women with anterior vaginal prolapse were r and omly assigned to undergo anterior repair by one of 3 techniques : st and ard , st and ard plus polyglactin 910 mesh , or ultralateral anterior colporrhaphy . Before and after operation , patients underwent physical examination staging of prolapse ; the International Continence Society system was used . Symptoms were assessed by question naire and visual analog scales . We defined " cure " as satisfactory ( stage I ) or optimal ( stage 0 ) outcome at points Aa and Ba . RESULTS Of 114 patients who were originally enrolled , 109 patients underwent operation , and 83 patients ( 76 % ) returned for follow-up . Mean age ( + /- SD ) was 64.7 + /- 11.1 years . At entry , 7 patients ( 7 % ) had stage I anterior vaginal prolapse ; 35 patients ( 37 % ) had stage II anterior vaginal prolapse ; 51 patients ( 54 % ) had stage III anterior vaginal prolapse ; and 2 patients ( 2 % ) had stage IV anterior vaginal prolapse . At a median length of follow-up of 23.3 months , 10 of 33 patients ( 30 % ) who were r and omly assigned to the st and ard anterior colporrhaphy group experienced satisfactory or optimal anatomic results , compared with 11 of 26 patients ( 42 % ) with st and ard plus mesh and with 11 of 24 patients ( 46 % ) with ultralateral anterior colporrhaphy . The severity of symptoms that were related to prolapse improved markedly ( preoperative score , 6.9 + /- 2.7 ; postoperative score , 1.1 + /- 0.8 ) . Twenty-three of 24 patients ( 96 % ) no longer required manual pressure to void after operation . CONCLUSION These 3 techniques of anterior colporrhaphy provided similar anatomic cure rates and symptom resolution for anterior vaginal prolapse repair . The addition of polyglactin 910 mesh did not improve the cure rate compared with st and ard anterior colporrhaphy Background . The aim of this prospect i ve , r and omised , study was to determine whether or not there was a higher incidence of bleeding , reoperation , urinary retention or bacterial count in the urine , depending on whether urinary catheter and vaginal pack was removed 3 h or 24 h after vaginal prolapse surgery . Methods . Some 136 women were r and omised into Group 1  ( removal of catheter and vaginal pack after 3 h ) , and Group 2  ( removal of catheter and vaginal pack after 24 h ) . Data on postoperative bleeding , reoperation , and urinary retention were collected . Preoperatively , day after operation , and 14 days after operation , a urine culture was performed . Results . There was no tendency towards more bleeding with early removal of vaginal pack and urinary catheter . No patients in either group were reoperated during the first 48 postoperative hours . Three patients in Group 1 required sterile intermittent catheterisation postoperatively , however , only once in 2 patients . There was a trend towards a higher postoperative bacterial count in patients in Group 2 ( p = 0.306 ) . Conclusion . We recommend removing the vaginal pack and urinary catheter after 3 h with careful monitoring of the patient 's voiding BACKGROUND Women without stress urinary incontinence undergoing vaginal surgery for pelvic-organ prolapse are at risk for postoperative urinary incontinence . A midurethral sling may be placed at the time of prolapse repair to reduce this risk . METHODS We performed a multicenter trial involving women without symptoms of stress incontinence and with anterior prolapse ( of stage 2 or higher on a Pelvic Organ Prolapse Quantification system examination ) who were planning to undergo vaginal prolapse surgery .  Women were r and omly assigned to receive either a midurethral sling or sham incisions during surgery . One primary end point was urinary incontinence or treatment for this condition at 3 months . The second primary end point was the presence of incontinence at 12 months , allowing for subsequent treatment for incontinence . RESULTS Of the 337 women who underwent r and omization , 327 ( 97 % ) completed follow-up at 1 year . At 3 months , the rate of urinary incontinence ( or treatment ) was 23.6 % in the sling group and 49.4 % in the sham group ( P<0.001 ) . At 12 months , urinary incontinence ( allowing for subsequent treatment of incontinence ) was present in 27.3 % and 43.0 % of patients in the sling and sham groups , respectively ( P=0.002 ) . The number needed to treat with a sling to prevent one case of urinary incontinence at 12 months was 6.3 . The rate of bladder perforation was higher in the sling group than in the sham group ( 6.7 % vs. 0 % ) , as were rates of urinary tract infection ( 31.0 % vs. 18.3 % ) , major bleeding complications ( 3.1 % vs. 0 % ) , and incomplete bladder emptying 6 weeks after surgery ( 3.7 % vs. 0 % ) ( P≤0.05 for all comparisons ) . CONCLUSIONS A prophylactic midurethral sling inserted during vaginal prolapse surgery result ed in a lower rate of urinary incontinence at 3 and 12 months but higher rates of adverse events . ( Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women 's Health ; OPUS Clinical Trials.gov number , NCT00460434 . ) OBJECTIVE : To report 2-year outcomes of a r and omized controlled trial comparing st and ard anterior colporrhaphy with reinforced vaginal paravaginal repair using xenograft or synthetic mesh in women with symptomatic anterior vaginal wall prolapse . METHODS : Women with stage II or greater anterior prolapse were r and omly assigned to three groups : anterior colporrhaphy , paravaginal repair with porcine dermis , or polypropylene mesh . Outcomes of prolapse stage , quality of life , degree of bother , and sexual symptoms were assessed by blinded examiners and vali date d measures at 2 years . Anatomic failure was defined as anterior prolapse at stage II or greater . Composite failure was defined as symptoms of “ bulge ” and anterior prolapse at stage II or greater . Power calculations determined 33 participants per arm would detect a 40 % difference in anatomic success between st and ard and grafted repair . & khgr;2 , Mann-Whitney U , and Student 's t tests were used for comparisons . RESULTS : Of the 99 participants enrolled , 78 ( 79 % ) completed a minimum of 2-year follow-up . Those with mesh had a significantly lower anatomic failure rate ( 18 % ) than both the porcine ( 46 % , P=.015 ) and colporrhaphy groups ( 58 % , P=.002 ) . All groups had statistically similar reductions in their prolapse and urinary symptom subscale scores . Composite failure was not statistically different between groups : 13 % colporrhaphy , 12 % porcine , and 4 % mesh . Two reoperations for anterior prolapse occurred in the porcine group . Mesh erosion rates were 14 % for the mesh group . CONCLUSION : Vaginal paravaginal repair with polypropylene mesh has the lowest anatomic failure rate when compared with that with xenograft and anterior colporrhaphy without differences in composite failures . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT0139171 . LEVEL OF EVIDENCE : Objective . To determine the long‐term objective and subjective outcomes of use of a porcine skin graft ( Pelvicol ™ ) compared with conventional colporrhaphy in recurrent pelvic organ prolapse surgery and to analyze risk factors and safety . Design . Open r and omized controlled multicenter study . Setting . Eight Swedish hospitals . Population . 135 consecutive women with recurrent cystocele and /or rectocele admitted for vaginal prolapse surgery ; 132 completed the study , 64 were r and omly allocated to receive conventional colporrhaphy and 68 to Pelvicol . Methods . Conventional anterior and posterior colporrhaphy and colporrhaphy with use of Pelvicol ™ mesh reinforcement . Clinical evaluation by means of pelvic organ prolapse quantification ( POP‐Q ) and symptom question naire preoperatively , three months and three years postoperatively . Main outcome measures . Anatomical and subjective outcome . Recurrence was defined as POP‐Q≥stage 2 . Results . At three‐month follow‐up , early recurrence/surgical failures occurred significantly more often in the Pelvicol ™ group , but at the three‐year follow‐up the recurrence rates were similar . The recurrence rates in the anterior compartment were 57–62 % and 44–23 % in the posterior compartment for the colporrhaphy and Pelvicol ™ groups , respectively . Symptoms were substantially and equally reduced in the two groups after surgery . Sexual activity and function did not seem to be affected adversely in any group . The complication rate was low . Risk factors for anatomical recurrence were age , body mass index and preoperative stage of the prolapse . Conclusions . With the surgical technique used in this study , Pelvicol ™ did not provide advantages over conventional colporrhaphy in recurrent pelvic organ prolapse concerning anatomical and subjective outcomes OBJECTIVE : To compare outcomes of anterior colporrhaphy alone to that reinforced with bovine pericardium graft . METHODS : Women with anterior vaginal wall prolapse were enrolled in a r and omized fashion in this grafted compared with nongrafted repair study . Outcome measures included pelvic organ prolapse quantification data , quality -of-life assessment , healing abnormalities , and complications . RESULTS : Ninety-four patients were enrolled . Seventy-two ( 77 % ) provided 1-year data , and 59 ( 63 % ) supplied 2-year data . Demographics and stage of prolapse were similar between groups at baseline . Postoperative complications consisted basically of low urinary tract infection and were low in both groups ( 10 in bovine pericardium graft and 16 in anterior colporrhaphy alone ) . One year after surgery , successful anterior vaginal wall support was obtained in 85.7 % of the bovine pericardium graft group and 78.4 % of anterior colporrhaphy – alone group ( P=.544 ) . For the cohort that comprised 2-year analyses , the success rate was 76.5 % for the bovine pericardium graft group and 63 % for anterior colporrhaphy – alone group ( P=.509 ) . Postoperative Urogenital Distress Inventory-6 and Pelvic Organ Prolapse – Urinary Incontinence Sexual Function Question naire-12 scores were uniformly improved over baseline in both groups . CONCLUSION : The use of bovine pericardium graft for anterior vaginal prolapse does not have higher complication rates or healing difficulties . At 1- and 2-year follow-up , anterior colporrhaphy with bovine pericardium reinforcement did not show a statistically significant improvement over colporrhaphy alone . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00860912 LEVEL OF EVIDENCE : Aim : To compare the effect of suprapubic and transurethral catheterization on postvoid residual volumes ( PRVs ) after cystocele repair . Methods : 126 women who underwent pelvic organ prolapse surgery including cystocele repair were r and omized to suprapubic or transurethral catheterization .  At the third postoperative day , PRVs were measured . The number of women with PRV > 150 ml , need for prolonged catheterization , recatheterization , length of hospital stay , frequency of urinary tract infections and complications were determined . Results : PRVs exceeded 150 ml in 13 out of 64 ( 20 % ) and 14 out of 62 ( 23 % ) women in the suprapubic and transurethral group , respectively ( p = 0.76 ) . In the suprapubic group a higher rate of urine leakage was noted ( 27 vs. 7 % , p = 0.003 ) . 10 women ( 16 % ) allocated to the suprapubic group switched to transurethral catheterization , because of problems with the suprapubic catheter . No protocol deviations were reported in the transurethral group . Of the women in both groups , 9 % developed urinary tract infections ( p = 0.93 ) . Conclusions : Suprapubic catheterization was comparable to transurethral catheterization in the prevention of postoperative voiding dysfunction after vaginal prolapse surgery , but it was associated with a higher rate of complications Objective To determine whether prolonged urinary bladder catheterisation  after vaginal prolapse surgery is advantageous Introduction and hypothesisThis study seeks to compare the small intestine submucosa ( SIS ) graft with traditional colporrhaphy ( TC ) for surgical treatment of anterior vaginal prolapse . Methods Subjects were r and omly assigned to  SIS ( n = 29 ) or to  TC ( n = 27 ) preoperatively and outcomes analyzed at 12 months postoperatively . The primary outcome was the absence of POP-Q stage ≥ II prolapse , and secondary outcome was improvement in quality of life . Data were compared with independent sample s or paired Student ’s t test . Results SIS group had 86.2 % anatomic cure compared to 59.3 % in TC ( p = 0.03 ) . SIS  improved point Ba measurement significantly ( −1.93 cm versus −1.37 cm , p = 0.02 ) . Both operations significantly improved quality of life , although there were no differences between the groups . We observed a greater number of complications in the SIS group , with no infections or erosion . Conclusions  SIS repair improved point Ba significantly . However , there were no differences observed in quality of life between the techniques OBJECTIVE To compare the effects of two surgical procedures for the correction of anterior vaginal wall prolapse ( AVWP ) on the lower urinary tract symptoms ( LUTS ) using symptom question naires and quality of life ( QoL ) . MATERIAL S AND METHODS One hundred women with Pelvic Organ Prolapse Quantification stage ( POP-Q ) ≥ 2 were r and omly distributed in two preoperatory groups . The first group ( mesh ) ( n = 45 ) received a polypropylene mesh ( PM ) implant and the control group ( n = 55 ) was su bmi tted to anterior colporraphy with or without synthetic sling . Postoperatory follow-up was done after 12 months . The primary objective was to compare the effect of the surgeries on LUTS using the final scores of the International Consultation on Incontinence Question naire Urinary Incontinence Short Form ( ICIQ-UI SF ) and Overactive Bladder Question naire ( OAB-V8 ) , as well as the analysis of the incapacitating urinary symptoms and ″de novo″ urinary symptoms after 12 months of surgery in both groups . RESULTS Although there was a different number of women in each group , r and omization was adequate , result ed in homogeneous groups that could be compared regarding socio demographic , clinical and gynecological ( POP-Q ) variables . Patients of both groups showed improvements regarding LUTS and QoL , whether using polypropylene mesh or not , based on the final scores of the ICIQ-UI SF and OAB-V8 question naires after 12-month follow-up . There were few incapacitating and ″de novo ″ urinary symptoms , without any significant statistical difference between both groups after 12 months of surgery . CONCLUSION There was a general improvement of LUTS and QoL in both groups after 12-month follow-up . However , there was no significant difference of LUTS , as well as the more incapacitating and ″de novo ″ urinary symptoms between both groups after 12 months of surgery To evaluate whether symptom resolution and sexual function is better after reinforcement with polypropylene mesh than with traditional anterior repair .  Ninety-seven patients were r and omized to anterior colporrhaphy and 105 to an operation with mesh .  Participants were evaluated up to 24 months by physical examination , st and ard questions , and question naire . The overall symptom rate did not differ between the groups , but a sensation of vaginal bulge was reported less frequently in the mesh group , the figures being 17 versus 5 ( p = 0.003 ) . The recurrence rate for the no-mesh group was 41 % and for the mesh group 11 % ( p < 0.001 ) . The dyspareunia score was statistically significantly lower in the mesh group ( p = 0.015 ) . The mesh exposure rate was 8 % . Sensation of vaginal bulge was relieved more efficiently by the mesh technique without causing dyspareunia Introduction and hypothesisIn surgery for pelvic organ prolapse ( POP ) the use of alloplastic meshes has become common . Among possible complications , mesh exposure is the most frequent problem . It is hypothesized that exposure rates are correlated to mesh weight and the amount of foreign material . Therefore , we conducted a prospect i ve open-label r and omized multicenter trial comparing a conventional polypropylene mesh ( PP ) with a partially absorbable polypropylene mesh ( PA ) for cystocele treatment . Methods A total of 200 patients with POP > stage I were r and omized either to a conventional or  a partially absorbable mesh . Exposure rates were observed after 3 , 12 , and 36 months and correlated to mesh material , patient characteristics , intraoperative data , and treatment centers . Furthermore , management of mesh exposure , satisfaction with surgery , and postoperative pain were evaluated . Results At all follow-up intervals mesh exposure rate was smaller in the group of the partially absorbable mesh ( 3 months PP 11.3 % vs PA 3.2 % , p = 0.0492 ; 12 months 6.6 % vs 6.3 % ; 36 months 7.5 % vs 3.4 % ) . Over the course of time , mesh exposure was observed in 27 patients , with surgical intervention necessary in 11 patients . The rate of recurrent POP was higher ( p > 0.05 ) in patients with the partially absorbable mesh . The majority of patients were fully satisfied with the operation ( 52.8 % ) and had no pelvic floor pain ( 67.5 % ) . Conclusion In this prospect i ve , r and omized trial with a long-term follow-up there was a low exposure rate in both treatment groups with a trend toward fewer exposures in the group of the partially absorbable mesh OBJECTIVE : To compare the diagnostic accuracy of two voiding trial methods to predict postoperative voiding dysfunction . METHODS : Women undergoing operations for urinary incontinence , prolapse , or both urinary incontinence and prolapse from November 2009 and March 2010 were r and omized into one of two groups : retro grade or spontaneous . All patients underwent both techniques of voiding trials with r and omization determining order . RESULTS : Fifty women were r and omized to 25 per group . Failure rates were 62 % for retro grade and 84 % for spontaneous . Women who failed both had 12.6±14.4 days of retention compared with 2.5±2.1 days for those who failed only one method ( P=.004 ) . The retro grade method had 94.4 % sensitivity and 58.1 % specificity to detect postoperative voiding dysfunction lasting at least 7 days compared with the spontaneous method with 100 % sensitivity and 25.8 % specificity . Positive and negative predictive values for the retro grade method were 56.7 % and 94.7 % , respectively , compared with the spontaneous method with 43.9 % and 100 % . Retro grade was preferred by patients ( 51.1 % compared with 44.4 % ) regardless of r and omization . CONCLUSION : The retro grade method is more accurate in evaluating postoperative voiding dysfunction , although both tests had a low positive predictive value . A longer period of retention was seen with failure of both methods . Retro grade was preferred by patients and provides an efficient alternative to the spontaneous method of voiding trial . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT01091844 . LEVEL OF EVIDENCE : Introduction and hypothesisOur aim was to compare anatomical and functional outcome between  vaginal colposuspension and transvaginal mesh . Methods This was a prospect i ve r and omized controlled trial in a teaching hospital . Sixty-eight women with stage ≥3 anterior vaginal wall prolapse according to the Pelvic Organ Prolapse Quantification ( POP-Q ) system were assessed , r and omized , and analyzed . Patients were r and omized to anterior colporrhaphy with vaginal colposuspension ( n = 35 ) or transvaginal mesh ( n = 33 ) . Primary outcome was objective cure rate of the anterior vaginal wall , defined as POP-Q ≤1 at 2 years . Secondary outcomes were functional results , quality -of-life ( QoL ) scores , mesh-related morbidity , and onset of urinary incontinence . Results The anatomical result for point Ba was significantly better at 2 years in the mesh group ( −2.8 cm ) than in the colposuspension group ( −2.4 cm ) ( p = 0.02 ) . Concerning POP-Q stages , the anatomical success rate at 2 years was 84.4 % for colposuspension and 100 % for mesh ( p = 0.05 ) . There were 5 anatomic recurrences ( 15.6 % ) in the colposuspension group . The erosion rate was 6 % ( n = 2 ) . No significant difference was noted regarding minor complications . Analysis of QoL question naires showed overall improvement in both groups , with no significant difference between them . Conclusions The vaginal colposuspension technique of anterior vaginal wall prolapse repair gave good anatomical and functional results at 2 years . Transobturator vaginal mesh gave better 2-year anatomical results than vaginal colposuspension , with overall improvement in QoL in both groups OBJECTIVE The purpose of this study was to reanalyze the results of a previously published trial that compared 3 methods of anterior colporrhaphy according to the clinical ly relevant definitions of success . STUDY DESIGN A secondary analysis of a trial of 114 subjects who underwent surgery for anterior pelvic organ prolapse who were assigned r and omly to st and ard anterior colporrhaphy , ultralateral colporrhaphy , or anterior colporrhaphy plus polyglactin 910 mesh from 1996 - 1999 . For the current analysis , success was defined as ( 1 ) no prolapse beyond the hymen , ( 2 ) the absence of prolapse symptoms ( visual analog scale ≤ 2 ) , and ( 3 ) the absence of retreatment . RESULTS Eighty-eight percent of the women met our definition of success at 1 year . One subject ( 1 % ) underwent surgery for recurrence 29 months after surgery . No differences among the 3 groups were noted for any outcomes . CONCLUSION Re analysis of a trial of 3 methods of anterior colporrhaphy revealed considerably better success with the use of clinical ly relevant outcome criteria compared with strict anatomic criteria Introduction The natural history of pelvic organ prolapse ( POP ) is poorly understood . We investigated the prevalence and risk factors of postnatal POP in premenopausal primiparous women and the associated effect of mode of delivery . Methods We conducted a prospect i ve cohort study in a tertiary teaching hospital attending 9,000 deliveries annually .  Collagen-diseases history and clinical assessment was performed in 202 primiparae at ≥1 year postnatally . Assessment included  Pelvic Organ Prolapse Quantification ( POP-Q ) system , Beighton mobility score , 2/3D-transperineal ultrasound ( US ) and quantification of collagen type III levels .  Association with POP was assessed using various statistical tests , including logistic regression , where results with p < 0.1 in univariate analysis were included in multivariate analysis . Results POP had a high prevalence : uterine prolapse 89 % , cystocele 90 % , rectocele 70 % and up to 65 % having grade two on POP-Q staging . The majority had multicompartment involvement , and 80 % were asymptomatic . POP was significantly associated with joint hypermobility , vertebral hernia , varicose veins , asthma and high collagen type III levels ( p < 0.05 ) . In multivariate logistic regression , only levator ani muscle ( LAM ) avulsion was significant in selected cases ( p < 0.05 ) . Caesarean section ( CS )  was significantly protective against cystocele and rectocele but not for uterine prolapse . Conclusions Mild to moderate POP has a very high prevalence in premenopausal primiparous women . There is a significant association between POP , collagen levels , history of collagen disease and childbirth-related pelvic floor trauma . These findings support a congenital contribution to POP etiology , especially for uterine prolapse ; however , pelvic trauma seems to play paramount role . CS  is significantly protective against some types of prolapse only Introduction and hypothesisThe aim of this study was to compare the lower urinary tract symptom changes and surgical outcome between the tension-free vaginal tape ( TVT ) procedure with and without concomitant stage II pelvic organ prolapse ( cystocele ) repair in a r and omized clinical trial setting . Methods Patients with urodynamically proven stress urinary incontinence ( SUI ) and asymptomatic stage II cystocele were r and omly and equally allocated to either a TVT and concomitant cystocele repair group or TVT only group . SUI was corrected with TVT in all cases . The cystocele repair procedure was performed with Gynemesh ® . Lower urinary tract symptoms and surgical outcome were assessed at postoperative year 1 . Lower urinary tract symptoms were assessed with the American Urological Association Symptom Score ( AUASS ) question naire , uroflowmetry , and postvoid residual ( PVR ) . Results The cure rate of TVT only and the concomitant repair group was 87 and 91 % , respectively ( p > 0.05 ) . Cystocele was cured in all patients in the concomitant repair group . After the operation , the total AUASS were 6.4 and 8.4 in the TVT only group and concomitant repair group , respectively , with no statistical difference . There was no difference in the change in peak flow rate ( Qmax ) and PVR between the two groups . The prevalence of postoperative mixed incontinence was not different between the two groups . Conclusions In patients with stage II cystocele and SUI , there was no difference in the surgical outcome and lower urinary tract symptoms between the TVT sling only group and concomitant repair group . Cystocele repair can be safely omitted in patients with stage II cystocele OBJECTIVE : To compare efficacy and safety of trocar-guided tension-free vaginal mesh insertion with conventional vaginal prolapse repair in patients with recurrent pelvic organ prolapse . METHODS : Patients with recurrent pelvic organ prolapse stage II or higher were r and omly assigned to either conventional vaginal prolapse surgery or polypropylene mesh insertion . Primary outcome was anatomic failure ( pelvic organ prolapse stage II or higher ) in the treated vaginal compartments . Secondary outcomes were subjective improvement , effects on bother , quality of life , and adverse events . Question naires such as the Incontinence Impact Question naire and Urogenital Distress Inventory were administered at baseline , 6 months , and 12 months . Anatomic outcomes were assessed by an unblinded surgeon . Power calculation with & agr;=0.05 and & bgr;=0.80 indicated that 194 patients were needed . RESULTS : Ninety-seven women underwent conventional repair and 93 mesh repair .  The follow-up rate after 12 months was 186 of 190 patients ( 98 % ) . Twelve months postsurgery , anatomic failure in the treated compartment was observed in 38 of 84 patients ( 45.2 % ) in the conventional group and in eight of 83 patients ( 9.6 % ) in the mesh group ( P<.001 ; odds ratio , 7.7 ; 95 % confidence interval , 3.3–18 ) . Patients in either group reported less bulge and overactive bladder symptoms . Subjective improvement was reported by 64 of 80 patients ( 80 % ) in the conventional group compared with 63 of 78 patients ( 81 % ) in the mesh group . Mesh exposure was detected in 14 of 83 patients ( 16.9 % ) . CONCLUSION : At 12 months , the number of anatomic failures observed after tension-free vaginal mesh insertion was less than after conventional vaginal prolapse repair . Symptom decrease and improvement of quality of life were equal in both groups . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00372190 . LEVEL OF EVIDENCE : OBJECTIVE To compare success rates between anterior colporrhaphy and abdominal paravaginal defect repair for treatment of anterior vaginal wall prolapse . METHODS This was a prospect i ve r and omized controlled trial comparing anterior colporrhaphy plus polyglactin 910 mesh ( vaginal ) to paravaginal defect repair ( abdominal ) in women with symptomatic anterior vaginal wall prolapse . Pelvic organ prolapse quantification staging ( POP-Q ) , pelvic floor distress inventory , pelvic floor impact question naire , and pelvic organ prolapse/urinary incontinence sexual question naires were administered pre and post-operatively . Women were followed up to 2 years . The primary outcome was anterior POP-Q stage , with failure defined as ≥stage II . RESULTS We enrolled 70 patients , 35 in each group . Demographic and most peri-operative characteristics were similar between the groups . Mean anterior vaginal wall prolapse repair time ( 39 min ) was shorter for vaginal versus abdominal repair ( 60 min ; P < 0.001 ) , with more concurrent hysterectomies in the vaginal ( 71 % ) versus abdominal group ( 42 % ) , P = 0.01 . At 2 years , objective failure rates for the vaginal and abdominal groups were 32 % and 40 % , respectively , P = 0.56 . Subjective failure rates were lower and similar for both groups . Patient satisfaction rates were 88 % for the vaginal and 73 % for the abdominal group , P = 0.11 . Quality of life question naires showed significant improvement from baseline but no difference between the groups ( P = 0.12 ) . CONCLUSIONS At 2 years follow-up , anterior colporrhaphy with polyglactin 910 mesh and abdominal paravaginal defect repair have similar success rates , with most objective failures being asymptomatic Objectives The goals of this study were to assess the effect of a st and ardized postoperative bowel regimen of over-the-counter medications on ( 1 ) time to first bowel movement ( BM ) and ( 2 ) pain level associated with first BM in subjects undergoing minimally invasive urogynecologic surgery .  Methods Eligible patients scheduled to undergo minimally invasive urogynecologic surgery were offered participation . Enrolled subjects were r and omized by computerized schedule . Demographic and perioperative data were collected . Subjects completed a vali date d question naire preoperatively and postoperatively assessing preexisting constipation , frequency and consistency of bowel movements , use of pain medications , mean daily pain level ( using visual analog scale ) , stool consistency , and pain associated with first postoperative bowel movement . The control group was instructed to take docusate sodium twice daily postoperatively . The treatment group took docusate sodium plus Miralax , fiber wafers , and bisacodyl suppositories as directed by protocol . Wilcoxon or t testing was used to compare continuous variables ; & khgr;2 testing was used for categorical relationships , and backward-elimination multiple regression was used to assess independent effects . Results Seventy-two subjects were enrolled and r and omized . Twelve subjects withdrew , leaving 60 ( 30 per group ) completing the study . There were no statistically significant differences between groups in baseline characteristics . Mean ( SD ) age was 63 ( 9 ) years for the control group and 58 ( 10 ) for the study group ( P = 0.06 ) . Mean pelvic organ prolapse stage  was III in each group . The mean ( SD ) operating room time was 198 ( 65 ) minutes for the controls and 216 ( 74 ) for the study subjects . Sixty-five percent underwent robot-assisted surgery ( 50 % hysterectomy and 63 % sacrocolpopexy ) . Ninety-eight percent of surgeries were performed under general anesthesia . Before adjustment , the mean ( SD ) time to first BM was 77 ( 24 ) hours in controls versus 64 ( 21 ) in the study patients ( P = 0.03 ) . Using multiple regression , baseline frequency of defecation ( 1–2 BMs/wk ) was directly associated with the time to first BM ( added 25.2 hours ; P = 0.009 ) and being in the study group was inversely associated ( first BM , 11.7 hours sooner ; P = 0.04 ) . No other variables were retained . There was no difference in pain associated with first postoperative BM ( visual analog scale , 3.6 ( 3.2 ) vs 3.7 ( 2.8 ) ; P = 0.98 ) , but those with prior complaints of vaginal or rectal splinting had higher pain scores ( 1.9 and 2.8 points higher , respectively ; P = 0.04 for both ) . There was a trend toward higher pain scores with higher postoperative daily narcotic intake ( P = 0.06 ) . No other variables were retained . There was a significant difference in recorded compliance between control versus study regimens ( 94 % vs 81 % , respectively ; P = 0.002 ) . Conclusions Mean time to first postoperative BM after minimally invasive urogynecologic surgery is more than 3.5 days with use of docusate sodium alone and is only slightly shorter when combination therapy is used . First BM after surgery is considered to be painful despite the use of medications . Future studies targeting postoperative discomfort/pain with defecation could target preoperative bowel regimens or more aggressive postoperative interventions . Regimens should remain simple to increase compliance PURPOSE We evaluated the impact of Burch colposuspension as an anti-incontinence measure in patients with urinary incontinence undergoing abdominal surgery for pelvic organ prolapse repair . MATERIAL S AND METHODS A total of 47 women with pelvic organ prolapse and urinary incontinence were r and omly assigned to abdominal pelvic organ prolapse repair and concomitant Burch colposuspension ( 24 patients , group A ) or pelvic organ prolapse repair alone without an anti-incontinence procedure ( 23 patients , group B ) . They were followed up at 3 , 6 and 9 months after surgery , and then annually . The primary outcome measures were anatomical outcome and changes in incontinence status as indicated by a bladder diary , the number of daily pads and the stress test . Secondary end points were changes in subjective symptoms and quality of life as measured by the Urogenital Distress Inventory and the Incontinence Impact Question naire . RESULTS In group A 13 of 24 patients ( 54.2 % ) were still incontinent after surgery compared with 9 of 23 ( 39.1 % ) in group B. The intragroup difference was significant ( group A p = 0.003 , group B p = 0.0001 ) , but there was no significant intergroup difference ( p = 0.459 for A vs B ) . No significant intergroup difference emerged in anatomical outcome . Urogenital Distress Inventory and Incontinence Impact Question naire scores improved in both groups ( p = 0.0001 ) but the intergroup difference was not significant in either question naire ( p = 0.769 and p = 0.327 , respectively ) . CONCLUSIONS Burch colposuspension does not provide any additional benefit in pelvic organ prolapse repair in patients with urinary incontinence Introduction and hypothesisThis study aims to compare the result of an incontinence procedure performed at the time of prolapse repair or 3 months later in women with pelvic organ prolapse ( POP ) and stress urinary incontinence ( SUI ) . Methods In a multicenter prospect i ve r and omized trial , women with POP and SUI were r and omized to have a tension-free vaginal tape ( TVT ) at the time of prolapse repair ( n = 87 ; group I ) or 3 months later ( n = 94 ; group II ) . Women in group II were evaluated for SUI 3 months after the prolapse repair . Those with confirmed SUI had a TVT performed ( n = 53 ) . The main evaluation of all women was 1 year after the last surgery . Results On-treatment analysis result ed in 95 % cure of SUI in group I and 89 % in group II ( p = 0.12 ) . Twenty-seven percent were cured after prolapse surgery alone . Conclusions No differences were found between the two treatment strategies , but almost one third of women were cured of SUI by prolapse surgery alone AIMS To investigate the urodynamic effects of anterior vaginal wall prolapse surgery using either trocar guided transvaginal mesh or colporraphy . METHODS A prospect i ve , r and omized multicenter trial enrolling 50 patients : 27 underwent anterior colporrhaphy and 23 anterior trocar guided transvaginal mesh .  Urodynamic assessment was performed pre- and two months postoperatively . RESULTS De novo stress urinary incontinence was significantly more common after trocar guided transvaginal mesh surgery compared to colporraphy . In comparison to baseline urodynamics , transvaginal mesh surgery result ed in a significant decrease in maximal urethral closing pressures ( MUCP ) whereas conventional anterior colporraphy had no significant effect on urodynamic parameters . CONCLUSION Trocar guided transvaginal mesh of anterior vaginal wall prolapse results in a lowering of MUCPs and increases the risk for de novo stress urinary incontinence compared to colporraphy PURPOSE We prospect ively compared transvaginal antimicrobial mesh ( MycroMesh * ) and anterior vaginal wall slings using an outcomes analysis . MATERIAL S AND METHODS Between August 1997 and November 1998 we implanted transvaginal slings in 40 consecutive women r and omized to a synthetic mesh ( 20 ) or vaginal wall ( 20 ) group . All patients had documented stress urinary incontinence on preoperative urodynamics . We prospect ively compared postoperative outcomes data obtained from pelvic examinations , cough stress test , cotton swab test and vali date d patient question naires using a visual analog scale . RESULTS Complete followup was available in all patients . Mean followup was 22 months ( range 12 to 27 ) . Stress incontinence was cured in 95 % of the mesh and 70 % of the vaginal wall group , and pelvic prolapse was cured in 100 % and 95 % , respectively . Transient de novo urge incontinence was noted in 12.5 % of the mesh and 14.3 % of the vaginal wall group . Mean postoperative cotton swab angle during Valsalva 's maneuver was 20 and 45 degrees for the mesh and vaginal wall groups , respectively . The incidence of urinary retention and tissue erosion was 0 % for both groups . The satisfaction rate was 100 % and 80 % for the mesh and vaginal wall groups , respectively . CONCLUSIONS The antimicrobial MycroMesh sling was superior to the vaginal wall sling for correction of stress incontinence and pelvic prolapse with comparatively low morbidity OBJECTIVE Our aim was to evaluate the efficacy of polyglactin 910 mesh in preventing recurrent cystoceles and rectoceles . STUDY DESIGN In a prospect i ve , r and omized , controlled trial , patients undergoing vaginal reconstructive surgery with cystoceles to the hymenal ring and beyond were r and omly selected to undergo anterior and posterior colporrhaphy with or without polyglactin 910 mesh reinforcement . Results were evaluated preoperatively and at 2 , 6 , 12 , and 52 weeks postoperatively . RESULTS A total of 161 women were r and omly selected for this study . One woman was excluded at the time of surgery , and 17 women were lost to follow-up . Eighty women received mesh  , and 80 did not . Both groups were found to be equivalent with respect to age , parity , concomitant surgery , and menopausal and hormone replacement status . Preoperatively 49 women had a central cystocele to the hymenal ring and 111 women had cystoceles beyond the introitus ; 91 women had a rectocele to the mid-vaginal plane , 31 to the hymenal ring , and 22 beyond the introitus . After 1 year , 30 ( 43 % ) of 70 subjects without mesh and 18 ( 25 % ) of 73 subjects with mesh had recurrent cystoceles beyond the mid-vaginal plane ( P = .02 ) . Eight women without mesh and 2 women with mesh had recurrent cystoceles to the hymenal ring ( P = .04 ) . No recurrent cystoceles beyond the hymenal ring occurred in either group . Multivariate logistic regression analysis showed concurrent slings to be associated with significantly fewer recurrent cystoceles ( odds ratio , 0.32 ; P = .005 ) , whereas the presence of mesh remained significantly predictive of fewer cystocele recurrences in this analysis . Thirteen recurrent rectoceles were noted 1 year postoperatively , with no differences between groups . CONCLUSION Polyglactin 910 mesh was found to be useful in the prevention of recurrent cystoceles OBJECTIVE To compare the anatomical and functional results of traditional anterior colporrhaphy and polypropylene mesh surgery in cystocele treatment . STUDY DESIGN Prospect i ve study conducted in the Urogynecology Clinic of Etlik Zubeyde Hanim Maternity and Women 's Health Teaching and Research Hospital between June 2006 and February 2007 . Forty patients with stage II and III cystocele according to the Pelvic Organ Prolapse Quantification system were allocated by a computer programme to conventional or mesh surgery .  Twenty patients each underwent anterior colporrhaphy ( group I ) or polypropylene mesh ( Sofradim ( ® ) , Parieten ) surgery ( group II ) . Both groups were followed for 12 months . RESULTS At the end of the 12th month , anatomical cure rates were 15/20 ( 75 % ) and 19/20 ( 95 % ) in groups I and II , respectively , and the difference between the two groups was statistically significant ( p<0.05 ) . De novo stress urinary incontinence developed in one patient in group I. Mesh erosion developed postoperatively in three cases ( 15 % ) . CONCLUSION In terms of anatomical cure rates  , polypropylene mesh surgery was the more successful treatment option when compared with anterior colporrhaphy at the end of 1 year follow-up BACKGROUND The use of mesh in prolapse surgery is controversial , leading to a number of enquiries into its safety and efficacy . OBJECTIVE To compare synthetic non-absorbable mesh inlay , biological graft and mesh kit with a st and ard repair in terms of clinical effectiveness , adverse effects , quality of life ( QoL ) , costs and cost-effectiveness . DESIGN Two r and omised controlled trials within a comprehensive cohort ( CC ) study . Allocation was by a remote web-based r and omisation system in a 1 :1 : 1 ratio ( Primary trial ) or 1 : 1 : 2 ratio ( Secondary trial ) , and was minimised on age , type of prolapse repair planned , need for a concomitant continence procedure , need for a concomitant upper vaginal prolapse procedure and surgeon . Participants and outcome assessors were blinded to r and omisation ; participants were unblinded if they requested the information . Surgeons were not blinded to allocated procedure . SETTING Thirty-five UK hospitals . PARTICIPANTS Primary study : 2474 women in the analysis ( including 1348 r and omised ) having primary anterior or posterior prolapse surgery . Secondary study : 398 in the analysis ( including 154 r and omised ) having repeat anterior or posterior prolapse surgery . CC3 : 215 women having either uterine or vault prolapse repair . INTERVENTIONS Anterior or posterior repair alone , or with mesh inlay , biological graft or mesh kit . MAIN OUTCOME MEASURES Prolapse symptoms [ Pelvic Organ Prolapse Symptom Score ( POP-SS ) ] ; prolapse-specific QoL ; cost-effectiveness [ incremental cost per quality -adjusted life-year ( QALY ) ] . RESULTS Primary trials : adjusting for baseline and minimisation covariates , mean POP-SS was similar for each comparison { st and ard 5.4 [ st and ard deviation ( SD ) 5.5 ] vs. mesh 5.5 ( SD 5.1 ) , mean difference ( MD ) 0.00 , 95 % confidence interval ( CI ) -0.70 to 0.71 ; st and ard 5.5 ( SD 5.6 ) vs. graft 5.6 ( SD 5.6 ) , MD -0.15 , 95 % CI -0.93 to 0.63}. Serious non-mesh adverse effects rates were similar between the groups in year 1 [ st and ard 7.2 % vs. mesh 7.8 % , risk ratio ( RR ) 1.08 , 95 % CI 0.68 to 1.72 ; st and ard 6.3 % vs. graft 9.8 % , RR 1.57 , 95 % CI 0.95 to 2.59 ] . There were no statistically significant differences between groups in any other outcome measure . The cumulative mesh complication rates over 2 years were 2 of 430 ( 0.5 % ) for st and ard repair ( trial 1 ) , 46 of 435 ( 10.6 % ) for mesh inlay and 2 of 368 ( 0.5 % ) for biological graft . The CC findings were comparable . Incremental costs were £ 363 ( 95 % CI -£32 to £ 758 ) and £ 565 ( 95 % CI £ 180 to £ 950 ) for mesh and graft vs. st and ard , respectively . Incremental QALYs were 0.071 ( 95 % CI -0.004 to 0.145 ) and 0.039 ( 95 % CI -0.041 to 0.120 ) for mesh and graft vs. st and ard , respectively . A Markov decision model extrapolating trial results over 5 years showed st and ard repair had the highest probability of cost-effectiveness , but results were surrounded by considerable uncertainty . Secondary trials : there were no statistically significant differences between the r and omised groups in any outcome measure , but the sample size was too small to be conclusive . The cumulative mesh complication rates over 2 years were 7 of 52 ( 13.5 % ) for mesh inlay and 4 of 46 ( 8.7 % ) for mesh kit , with no mesh exposures for st and ard repair . CONCLUSIONS In women who were having primary repairs , there was evidence of no benefit from the use of mesh inlay or biological graft compared with st and ard repair in terms of efficacy , QoL or adverse effects ( other than mesh complications ) in the short term . The Secondary trials were too small to provide conclusive results . LIMITATIONS Women in the Primary trials included some with a previous repair in another compartment . Follow-up is vital to identify any long-term potential benefits and serious adverse effects . FUTURE WORK Long-term follow-up to at least 6 years after surgery is ongoing to identify recurrence rates , need for further prolapse surgery , adverse effects and cost-effectiveness . TRIAI REGISTRATION Current Controlled Trials IS RCT N60695184 . FUNDING This project was funded by the National Institute for Health Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 20 , No. 95 . See the NIHR Journals Library website for further project information OBJECTIVE We wished to determine the feasibility of a single-centre r and omized controlled trial to investigate whether avoiding cystocele plication in women undergoing transvaginal repair of cystocele decreases the need for catheterization beyond the second postoperative day . METHODS Patients undergoing transvaginal repair of cystocele were r and omly assigned to either have or not have plication sutures during their procedure . We assessed the success of recruitment , physician acceptability , and adherence to protocol , and we also assessed the need for catheterization beyond the second postoperative day . RESULTS Twenty-two women were r and omized ( a recruitment rate of 85 % ) , and participating surgeons did not feel that one surgical technique was superior to the other . There were no protocol violations after r and omization . No cases of postoperative voiding dysfunction were identified . CONCLUSION A multicentre r and omized controlled trial is required to determine the short-term and long-term risks and benefits of avoiding plication sutures in women undergoing transvaginal repair of cystocele . If patients and physicians support the study protocol , conducting such a trial is feasible Summary The effects at 2 years of polyglactin ( Vicryl ) mesh inlay and polydioxanone ( PDS ) or polyglactin ( Vicryl ) suture material on prolapse symptoms , urinary , bowel , sexual function and prolapse related Quality -of-Life ( QoL ) in women undergoing pelvic organ prolapse surgery were evaluated in a r and omised controlled trial with a 2 × 2 factorial design of Vicryl mesh ( n = 32 ) or not ( n = 34 ) and PDS ( n = 33 ) or Vicryl suture ( n = 33 ) . The response rate at 2 years was 82 % . There were no differences in the prolapse symptom scores between the r and omised groups . Prolapse-related QoL score ( mean difference : 2.05 , 95 % CI 0.19–3.91 ) and urinary incontinence score ( mean difference : 2.56 , 95 % CI 0.02–5.11 ) were significantly lower ( better ) in women who had Vicryl compared with PDS sutures . The apparent superiority of the prolapse-related QoL and urinary incontinence scores in women using Vicryl suture material ( vs PDS ) needs to be confirmed in a larger trial Objective Placement of vaginal packing after pelvic reconstructive surgery is common ; however , little evidence exists to support the practice . Furthermore , patients have reported discomfort from the packs . We describe pain and satisfaction in women treated with and without vaginal packing .  Methods This institutional review board – approved r and omized-controlled trial enrolled patients undergoing vaginal hysterectomy with prolapse repairs . The primary outcome was visual analog scales ( VASs ) for pain on postoperative day 1 . Allocation to “ packing ” ( “ P ” ) or “ no-packing ” ( “ NP ” ) arms occurred intraoperatively at the end of surgery . Visual analog scales regarding pain and satisfaction were completed early on postoperative day 1 before packing removal . Visual analog scale scores for pain , satisfaction , and bother attributable to packing were recorded before discharge . All packing and perineal pads were weighed to calculate a “ postoperative vaginal blood loss . ” Perioperative data were collected from the hospital record . Our sample size estimation required 74 subjects . Results Ninety-three women were enrolled . After exclusions , 77 were r and omized ( P , 37 ; NP , 40 ) . No differences were found in surgical information , hemoglobin levels , or narcotic use between groups . However , “ postoperative vaginal blood loss ” was greater in packed subjects ( P < 0.001 ) . Visual analog scale scores for pain before removal of packing ( P , 41.6 vs NP , 46.3 ; P = 0.43 ] and before discharge ( P , 35.0 vs NP , 40.0 ; P = 0.43 ] were not significantly different between treatment arms . Likewise , VAS scores for satisfaction before removal of packing ( P , 81.0 vs NP , 90.0 ; P = 0.08 ] and before discharge ( P , 90.0 vs NP , 90.5 ; P = 0.60 ] were not significantly different . Packed patients noted lower nursing verbal pain scores ( P = 0.04 ) and used less ketorolac ( P = 0.01 ) . Bother from packing was low overall . Conclusions Although there was no difference based on VAS , women receiving vaginal packing had lower nursing documented pain and used less ketorolac than packed women . Vaginal packing may provide benefit and can remain part of the surgical practice OBJECTIVE Dexamethasone is a corticosteroid with minimal side effects that may improve quality of recovery . We sought to evaluate st and ard use of this medication prior to vaginal reconstructive surgery . STUDY DESIGN This was a double-blind , r and omized , placebo-controlled trial of women undergoing vaginal reconstructive surgery for pelvic organ prolapse . Patients scheduled for an intraperitoneal vaginal vault suspension , with general anesthesia and an overnight stay , were enrolled . The intervention arm received dexamethasone 60 minutes prior to surgery , and controls received placebo .  Postoperative pain medications , antiemetics , and voiding trials were st and ardized . Our primary outcome was the difference in Quality of Recovery ( QoR-40 ) scores on postoperative day 1 . Secondary measures included Postoperative Nausea and Vomiting Intensity scores , and visual analog scales for nausea/vomiting , and pain . Our power calculation demonstrated 31 subjects in each group would be necessary to document difference in QoR-40 scores ; to allow for attrition , a goal of 74 subjects was set . RESULTS Seventy-four women were enrolled and r and omized . Two withdrew , 9 were excluded , and 63 were analyzed ( 36 placebo , 27 dexamethasone ) . The mean age was 63 years . No significant differences were noted among demographics other than American Society for Anesthesiologists class ; there were greater numbers of dexamethasone subjects that were class 3 ( 5 vs 11 ; P = .030 ) . Postoperatively , more patients in the placebo group required  promethazine as a rescue antiemetic for control of their nausea/vomiting ( 11 vs 2 ; P = .029 ) . Placebo subjects also failed their voiding trials more frequently , which remained following a logistic regression controlling for suburethral sling ( 30 vs 15 ; P = .037 ) . Regarding the QoR-40 following surgery , the emotional state domain declined less in dexamethasone patients ( -14.3 , interquartile range [ IQR ] , 16.8 vs -4.6 , IQR , 20.1 ; P = .042 ) , indicating better symptoms . Whereas pain scales were similar , the visual analog scales for nausea/vomiting was lower in dexamethasone subjects ( 0.7 ; IQR , 4.1 vs 0.4 ; IQR , 1.4 ; P = .042 ) . Postoperative Nausea and Vomiting Intensity scores were not significantly different ; nevertheless , twice as many placebo subjects had severe range symptoms ( 4 vs 2 ; P = .47 ) . No adverse effects from the dexamethasone were noted . CONCLUSION Use of dexamethasone prior to vaginal reconstructive surgery was associated with less nausea/vomiting and need for antiemetics as well as greater success with voiding trials . Furthermore , quality of recovery was enhanced , suggesting use of dexamethasone should be considered for these patients OBJECTIVE : To compare rates of de novo dyspareunia in women with and without vaginal dilator use after posterior colporrhaphy . METHODS : This r and omized controlled trial included sexually active patients with prolapse and no bothersome baseline dyspareunia undergoing posterior colporrhaphy . Patients were r and omized to daily vaginal dilator use  from postoperative weeks 4 through 8 or to no dilator use . Pelvic organ prolapse quantification examination and vaginal caliber were measured at baseline , 8 weeks , and 6 months postoperatively . Sexual function was evaluated at baseline , 3 months , and 6 months postoperatively using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Question naire-12 . Participants completed a Patient Global Impression of Improvement at 3 months and 6 months postoperatively . RESULTS : Sixty patients were r and omized : 30 in the dilator group and 30 in the control group . There were no differences in baseline characteristics and postoperative vaginal caliber between groups . At 3 months , 9.5 % of patients reported de novo dyspareunia in the dilator group compared with 19.2 % of control patients ( P=.44 ) . At 6 months , 12.5 % of patients in the dilator group reported de novo dyspareunia compared with 3.8 % of control patients ( P=.34 ) . There was a 13 % loss-to-follow-up rate , and therefore we did not meet appropriate power to detect a difference . There were no differences in overall sexual function or Patient Global Impression of Improvement scores between groups at 3 months and 6 months . CONCLUSION : There were no significant differences in de novo dyspareunia rates , overall postoperative sexual function scores , or global improvement scores between those using vaginal dilators compared with control patients . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT01299363 . LEVEL OF EVIDENCE : In a multicentre r and omised , unblinded patient preference pilot trial to assess the feasibility of a definitive r and omised trial comparing colposuspension with tension‐free vaginal tape ( TVT ) plus anterior repair in women with incontinence and prolapse , we found that 31 of 56 eligible women agreed to participate ( 55 % ) . Recruitment was more successful face to face ( 87 % ) than by letter ( 16 % ) . Only four of our women agreed to be r and omised , 21 ( 68 % ) chose  anterior repair + TVT and six ( 19 % ) chose colposuspension . This study demonstrates the importance of pilot work for complex trials to identify issues likely to adversely affect recruitment STUDY OBJECTIVE Compare the effectiveness of nerve stimulator-guided pudendal nerve block ( PNB ) vs general anesthesia ( GA ) for anterior and posterior ( AP ) colporrhaphy in terms of pain relief and analgesic consumption within 24 and 48 hours postoperatively . DESIGN Prospect i ve r and omized trial . PATIENTS Fifty-seven patients whose ages ranged between 20 and 53 years scheduled to undergo AP colporrhaphy due to the presence of cystorectocele . INTERVENTIONS Patients were r and omly assigned into 2 groups receiving either nerve stimulator-guided PNB ( n = 28 ) or GA ( n = 29 ) . A total volume of 0.7 mL/kg of the local anesthetic mixture was injected at 4 sites . MAIN RESULTS Both groups were similar with respect to age , weight , height , and surgery duration . There was a significant difference in average pain scores within the first and second postoperative days ( P values = .005 and .004 , respectively ) . Total analgesic consumption ( ketoprofen and tramadol ) was significantly lower in the PNB within the first ( P values = .018 and .010 ) and second postoperative days ( P values = .041 and .011 ) , respectively . Return to normal daily activity was significantly ( P < .0001 ) shorter in the PNB group compared with the GA group ( 3.6 days vs 12.2 days ) . A total of 71.4 % of the patients in the PNB group were satisfied compared with 27.8 % in the GA group ( P < .0001 ) . Surgeon satisfaction was significantly higher in the PNB group ( 82.1 % vs 34.5 % , P < .0001 ) . CONCLUSION This r and omized controlled trial demonstrated that nerve stimulator-guided PNB could be used as an alternative to GA for AP repair of stages I and II prolapse because it is associated with less postoperative pain and analgesic consumption , in addition to shorter duration of recovery R and omised trials and their syntheses in meta‐analyses offer a unique opportunity to assess the frequency and severity of adverse reactions
Introduction We assessed outcome and outcome -measure reporting in r and omised controlled trials evaluating surgical interventions for anterior-compartment vaginal prolapse and explored the relationships between outcome reporting quality with journal impact factor , year of publication , and method ological quality .