TVT-O vs TVT: a randomized trial in patients with different degrees of urinary stress incontinence. Cadaveric fascia lata versus intravaginal slingplasty for the pubovaginal sling: surgical outcome, overall success and patient satisfaction rates. Autologous fascial sling vs polypropylene tape at short-term followup: a prospective randomized study. Laparoscopic colposuspension versus vaginal suburethral slingplasty: a randomised prospective trial. Tension-free vaginal tape versus transobturator tape as surgery for stress urinary incontinence: results of a multicentre randomised trial. Tension free vaginal tape versus Burch colposuspension for treatment of female stress urinary incontinence. Randomized clinical trial comparing suprapubic arch sling (SPARC) and tension-free vaginal tape (TVT): one-year results. Randomized comparison of the suprapubic arc sling procedure vs tension-free vaginal taping for stress incontinent women. Prospective clinical trial comparing Obtape and DUPS to TVT: one-year safety and efficacy results. A randomized comparison of transobturator tape and Burch colposuspension in the treatment of female stress urinary incontinence. Tension-free vaginal tape versus tension-free vaginal tape obturator in women with stress urinary incontinence. Efficacy, safety and hospital costs of tension-free vaginal tape and pubovaginal sling in the surgical treatment of stress incontinence. Burch colposuspension and tension-free vaginal tape in the management of stress urinary incontinence in women. A multicenter, prospective, randomized clinical trial comparing tension-free vaginal tape surgery and no treatment for the management of stress urinary incontinence in elderly women. Tension-free vaginal tape and laparoscopic mesh colposuspension for stress urinary incontinence. [Comparative study of tension-free vaginal tape and fascia lata for stress urinary incontinence]. Cost-analyzes based on a prospective, randomized study comparing laparoscopic colposuspension with a tension-free vaginal tape procedure. Comparison of tension-free vaginal taping versus modified Burch colposuspension on urethral obstruction: a randomized controlled trial. Functional results after the suburethral sling procedure for urinary stress incontinence: a prospective randomized multicentre study comparing the retropubic and transobturator routes. Prospective randomized comparison of transobturator suburethral sling (Monarc) vs suprapubic arc (Sparc) sling procedures for female urodynamic stress incontinence. Laparoscopic Burch colposuspension versus tension-free vaginal tape: a randomized trial. Peri-operative morbidity and early results of a randomised trial comparing TVT and TVT-O. Tension-free vaginal tape compared with laparoscopic Burch urethropexy. Suburethral slingplasty evaluation study in North Queensland, Australia: the SUSPEND trial. Tension-free vaginal tape (TVT) and intravaginal slingplasty (IVS) for stress urinary incontinence: a multicenter randomized trial. Comparison of the efficacy of Burch colposuspension, pubovaginal sling, and tension-free vaginal tape for stress urinary incontinence. Prospective comparison of the 'inside-out' and 'outside-in' transobturator-tape procedures for the treatment of female stress urinary incontinence. One-year follow-up of tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVT-O) for surgical treatment of female stress urinary incontinence: a prospective randomised trial. A prospective trial comparing tension-free vaginal tape and transobturator vaginal tape inside-out for the surgical treatment of female stress urinary incontinence: 1-year followup. Monarc vs TVT-O for the treatment of primary stress incontinence: a randomized study. Comparative study of autologous pubovaginal sling and synthetic transobturator (TOT) SAFYRE sling in the treatment of stress urinary incontinence. A randomized comparison between monofilament and multifilament tapes for stress incontinence surgery. A randomized controlled equivalence trial of short-term complications and efficacy of tension-free vaginal tape and suprapubic urethral support sling for treating stress incontinence. A randomized trial comparing TVT with TVT-O: 12-month results. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence.
TVT-O and TVT were compared in patients stratified according the severity of Stress Urinary Incontinence (SUI). Those patients with intrinsic sphincter deficiencies, overactive bladders, associated prolapses, neurovegetative disorders and recurrent SUI or under rehabilitative/medical therapies were all excluded. There were 208 women included. Operating times were longer, and postoperative pain greater for TVT (p < 0.001). TVT produced longer hospitalizations in severe SUI patients (p < 0.001). After 1 year of follow-up, incontinence was cured in all mild SUI patients with both techniques, in all severe SUI patients when treated with TVT and in 66% of them when treated with TVT-O (p < 0.001). Vaginal perforations occurred during the TVT-O (p = 0.01), bladder perforations during TVT (p = NS), bladder obstructions in mild SUI patients after TVT (p < 0.001). The severity of SUI is an important parameter that influences results after TVT-O and TVT, and could be used to guide surgeons in selecting the most effective intervention. A wide variety of surgical procedures has been used to treat female stress urinary incontinence (SUI). The purpose of this study was to compare cadaveric fascia lata (CFL) sling with intravaginal slingplasty (IVS) in the surgical treatment of SUI.
                One hundred and thirty-nine women with SUI were randomly assigned to either CFL sling (n = 67) or IVS (n = 72). Concomitant urinary urge incontinence was present in 49 patients (73%) in the CFL sling and 44 patients (61%) in the IVS group. Daily mean pad usage was 4.1 +/- 3.5 in the CFL sling and 2.9 +/- 1.7 in the IVS group. The objective cure rate was evaluated by the pad test, and patient satisfaction rate was assessed by a subjective questionnaire.
                The surgical results of both procedures with a follow-up 12 months were documented. The overall success rate was 79% in the CFL sling and 70.8% in the IVS (p = 0.261). In contrast patient satisfaction rates were 82 and 87.5%, respectively (p = 0.210). Comparison of the CFL sling with IVS showed persistent urinary urge incontinence in 67 and 25% (p = 0.0001) and de novo urinary urge incontinence in 22 and 6.9%, respectively (p = 0.009). The groups did not differ significantly with respect to intraoperative and postoperative complications.
                There is no statistical difference in the overall success, satisfaction and complication rates in either group. In our series, both procedures were found to be effective, durable and significantly improved quality of life in patients with SUI but long-term results are awaited.
                (c) 2008 S. Karger AG, Basel. The incidence of urinary incontinence in women of childbearing age is about 30%. Around half have stress incontinence. Many treatment modalities have been elucidated to treat stress incontinence, and among the most popular are rectus fascia sling and tension-free vaginal tape (TVT). The introduction of TVT to the urological armamentarium put a multiplicity of synthetic materials into use in the correction of stress urinary incontinence. A comparison of the impact of these 2 commonly used techniques is needed.
                A total of 53 female patients older than 21 years (mean age 45.09) were randomized, using closed envelopes, to undergo TVT or rectus fascia sling. Randomization was performed after patients received spinal anesthesia. One surgeon performed the 2 types of treatment. Associated grade 2 cystocele was simultaneously corrected. Patients with bladder or urethral pathology, as well as those with cystocele greater than grade 2, were excluded from analysis.
                All 53 patients completed 6 months of followup and all had stress urinary incontinence. There were 15 patients who underwent sling surgery and 17 who underwent TVT who had concomitant grade 1 or 2 cystocele. No statistically significant difference was found between the 2 groups at baseline. Cure was accomplished in 23 of 25 (92%) with sling and in 26 of 28 (92.9%) with TVT at first followup visit (1 week). There were 7 patients who needed at least 1 extra week of catheterization in the sling group and 3 in the TVT group. No significant difference was detected in terms of post-void residual urine, symptom score, and filling and voiding parameters. At 6 months 1 patient had de novo detrusor overactivity and 7 had wound pain. Compared to those with TVT, 2 cases of sling were considered treatment failures, none had de novo overactivity and 2 had wound pain. None of the patients had symptoms suggestive of urethral erosion.
                Rectus fascia sling and TVT seem to be equally effective regarding primary outcome measure (ie cure of stress incontinence). Symptom score related to incontinence surgery as well as simultaneous correction of cystocele are comparable in the 2 groups. Fascial sling is a longer treatment process yet it is more economical. Longer followup is vital before rigorous conclusions can be drawn. This study aimed to determine if laparoscopic colposuspension (LC) was as effective as vaginal suburethral slingplasty (SPARC).
                Ninety-seven women with urodynamic stress incontinence were prospectively randomised to LC (n=48) or SPARC (n=49). Outcome measures were measured at, baseline, six months (n=87) and two years (n=58), and comprised leakage episodes per week and visual analogue scale (VAS) of incontinence severity. The LC and SPARC groups at baseline had similar leaks per week (8.8 vs 9.8) and VAS (5.6 vs 5.9).
                Laparoscopic colposuspension took longer to perform (48 vs 30 mins, P<0.001), had a slightly higher blood loss (104 vs 82 mL, P<0.01), had a longer hospitalisation (4.0 vs 1.5 days, P<0.001) and had a longer time to resumption of normal activities (3.6 vs 2.8 week, P<0.01). At six months there were no significant differences between LC and SPARC with regard to leaks per week (1.1 vs 2.6) and VAS (1.3 vs 0.7). The success rates were similar (88.3 vs 81.8%). These results again had no significant differences at two years (leaks per week 2.1 vs 3.5, and VAS 1.7 vs 2.2). At two years, the cure/improved rates again found no significant difference (81.5 vs 77.4%)
                Laparoscopic colposuspension is as effective as vaginal suburethral slingplasty after two years' follow-up. This prospective, multicentre, randomised study compared the safety and success rate of tension-free vaginal tape (TVT) and transobturator tape (TOT) in treatment of female stress urinary incontinence.
                Of 148 women, 73 were randomised to TVT and 75 to TOT. Preoperative workups included case history, clinical examination, Urogenital Distress Inventory and Impact Incontinence Quality of life questionnaires, 1-h pad test, pelvic ultrasound, and urodynamics. Intra- and postoperative complications were the primary end point; subjective and objective changes in SUI, and postoperative voiding dysfunctions were secondary end points. Patients were classified into two main categories: dry (no leakage during clinical and/or stress test and/or reported by patients) versus wet. Patients who referred being wet were separated into "improved" or "failure" on subjective analysis. Other outcome variables were quality of life questionnaires and VAS scale. Clinical checkups were conducted at 3, 6, 12 mo, and then annually.
                Both techniques are safe and no significant differences emerged in intra- and postoperative complications. At a mean follow-up of 31 mo, the overall objective cure (dry) was 71.4% for TVT and 77.3% for TOT (p=ns). When one considered "dry" plus "wet but improved," these values increased to 90% and 90.6%, respectively (p=ns). Median satisfaction rate was 9 (range: 1-10) for both procedures. Postoperative storage symptoms are a controversial issue; they persisted in 44% of patients in TVT group versus 24% in TOT group (p<0.053).
                TOT appears as safe and effective as TVT in surgery for female SUI, with minimal complications at mean follow-up of 31 mo. Many surgical procedures have been proposed for treatment of stress urinary incontinence (SUI) but none of them has proved completely successful. The aim of this study is to compare the efficacy and safety of tension free vaginal tape (TVT) with Burch colposuspension in the treatment of SIU.
                Fifty female patients, presenting with SUI were randomly divided into two equal groups. SUI was confirmed using urodynamic study in all patients. Group 1 (n=25) patients underwent Burch colposuspension while Group 2 (n=25) underwent TVT. Patients with high grade cystocele, previous surgical failure for SUI, uninhibited detrusor contraction during bladder filling on urodynamic study and incompetent internal sphincters were excluded from this study. A patient was declared cured of SUI, if 3-6 months after surgery she had no SUI. The procedure was judged to be a failure if 3-6 months after surgery, patient had SUI.
                In group 1 patients, 72% were completely cured, 16% improved and 12% showed no improvement. In group 2 patients, 72 were completely cured, 20% improved and only 8% showed no improvement. There was no difference between the two groups in terms of cure rates. Operative time for TVT was significantly less compared to Burch. Postoperative pain was less in TVT than Burch. Return to normal activity was earlier in TVT compared to Burch group. Intra operative perforation of the urinary bladder occurred in 8% of patients in group 2. Urine retention occurred in 12% of patients in group 1 compared to 20% in group 2. This was successfully managed conservatively. De novo urgency developed in 12% in group I and 8% in group II and was successfully managed by medical treatment.
                The success rates of TVT and Burch colposuspension in the treatment of SUI in our experience are very similar. However, TVT is associated with less morbidity. We recommend TVT procedure for females with genuine SUI. Suprapubic Arch sling (SPARC) has been initially presented as being comparable to Tension-free Vaginal Tape (TVT) without published trials. To test the safety and efficacy of this new product, we designed a prospective, randomized clinical trial with a minimum follow-up of 1 year.
                84 women presenting with Stress Urinary Incontinence (SUI) were randomly assigned to SPARC or TVT as a minimally invasive mid-urethral sling procedure. All patients were re-evaluated at 1, 6, and 12 months. Symptom assessment, Incontinence Impact Questionnaire (IIQ), physical examination, Uro-Dynamic Studies (UDS) and 1-hour pad test were repeated at 1-year follow-up.
                41 patients were randomized to SPARC and 43 to TVT. The two groups had similar baseline characteristics. Both procedures resulted in similar peri-operative complications: bladder perforation (24% vs. 23%), median estimated blood loss (0-50 ml), median hospital stay (1-night), post-operative analgesia, and persistent urinary retention necessitating tape resection (2 patients in each group). There were three other complications in the SPARC group: tape erosion, infected pelvic hematoma, and urinary tract infection. At 12 months, there was no statistically significant difference between SPARC and TVT, in terms of objective cure rates as determined by 1-hour pad test of less than two grams (83% vs. 95%; p< or =0.1; 12% difference, 95% CI: 25.4% to -1.4%) and subjective cure rates as determined by IIQ scores (49.9+/-25.6 vs. 45.3+/-18.4; p=0.46).
                At 1-year follow-up, there is no statistically significant difference between SPARC and TVT. Longer follow-up is needed to confirm these results. The purpose of this study was to compare the surgical outcome and attendant complications of the suprapubic arc (SPARC) sling and tension-free vaginal tape (TVT) procedures. Sixty-two women with genuine stress incontinence (GSI) alone or combined with pelvic prolapse less than International Continence Society (ICS) stage II were randomly allocated to either SPARC or TVT groups. A routine suprapubic ultrasonography was performed for all patients 1 day after the anti-incontinence operation. A comparison of the peri- and postoperative results comprising surgical outcomes and complications revealed no significant differences between the two groups. Although the difference in the rates of bladder injury was not statistically significant (SPARC 12.9 vs TVT 0.0%, p = 0.112), it was clinically significant. Routine suprapubic ultrasonography revealed eight subjects had retropubic hematomas greater than 5 cm. The cure rate for SPARC was not significantly different from TVT (80.7 vs 87.1%, p = 0.706). We concluded that the SPARC sling and TVT procedures proved to be equally effective. Subsequent suprapubic ultrasonography, in particular for the symptomatic patients, was found to be of clinical merit. Obtape and DUPS are modifications of the original TVT procedure. To test these new products in terms of safety and efficacy, we designed a prospective clinical trial with a follow-up of at least 1 yr.
                We randomized 190 consecutive females with SUI for this study. They were evaluated by history, ICIQ-SF, physical examination, cystoscopy, UDS, and the 1-h pad test. Patients were reevaluated at 1, 6, and 12 mo. The ICIQ-SF and pad test were repeated at 1-yr follow-up.
                There were 78, 32, and 80 patients in the Obtape, DUPS, TVT arms, respectively. An interim analysis after 32 patients in each arm indicated postoperative retention rates of 3 (9.4%), 6 (18.8%), and 4 (12.5%) patients in Obtape, DUPS, and TVT groups, respectively. Because of higher retention rate and suprapubic discomfort, DUPS was discontinued. At the end of the study, complete retention rates were 6 (7.8%), 6 (18.8%), and 6 (7.5%) in Obtape, DUPS, and TVT, respectively. TVT was the only procedure with bladder perforations at a rate of 14%. However, Obtape and DUPS were associated with more postoperative complications including complete retention, urethrolysis, hematoma, mesh erosion, UTI, and wound infection (13%, 28%, and 8%; p< or =0.025). At 1 yr, 83%, 94%, and 86% of patients in the Obtape, DUPS, and TVT groups were objectively cured (p>0.05).
                TVT was the only procedure associated with bladder perforation, but there were more postoperative complications with Obtape and DUPS. No statistically significant differences in cure rates were observed at 1-yr follow-up. Longer follow-up is needed to confirm these results. This study was performed to compare the efficacy of transobturator tape (TOT) and Burch colposuspension in the treatment of female stress urinary incontinence (SUI). This is a prospective randomized single blind study of 100 women diagnosed as with urodynamic SUI who were randomized either to TOT procedure (n = 49) or Burch procedure (n = 51). The outcome was evaluated at 1 and 2 years. The mean operation time and hospital stay were significantly shorter in the TOT group compared to Burch group (p < 0.001). Procedure-related complications and postoperative voiding problems including postoperative urinary retention, de novo voiding difficulties and de novo urge incontinence were similar in the two groups. Both the subjective and objective cure rates of SUI at 1 year were 85.7 and 87.5%, respectively, in the TOT group. This was similar to subjective and objective cure rates at one year of 84.3% (p = 0.8) and 80.3% (p = 0.4) in the Burch group, respectively. At the end of 2 years, 32 patients were available in the TOT group and 31 patients were available in the Burch group for analysis. Both the subjective and objective cure rates of SUI at 2 years were 87.5 and 87.5% in the TOT group which was similar to the 87% (p = 0.9) and 83.8% (p = 0.6) in the Burch group, respectively. TOT procedure results in similar cure rates of SUI at 1 and 2 years compared to Burch procedure. The TOT procedure has a shorter operative time and length of hospital stay. To assess the efficacy and complications of tension-free vaginal tape (TVT) versus tension-free vaginal tape obturator in women with urodynamic stress incontinence.
                Prospective, randomized study. Initially, 91 patients were included in the study and 89 of them were available at 12 months follow-up. Forty-six patients were subjected to classic TVT procedure and 43 to transobturator vaginal tape from inside to outside (TVT-O) operation. There was no significant difference between the groups for age, BMI, menopausal status and prolapse. No patients had cystocele greater than stage I. Subjective and objective cure and improvement rate, mean operative time, hospital stay and complications incidence were assessed.
                Mean operative time was significant shorter in the TVT-O group (17.4 +/- 6.9 min) compared to the TVT group (26.7 +/- 8.6 min). There was no significant difference in the duration of hospital stay between two groups. The objective cure rate for TVT group was 89%, the improvement rate was 6.5%, the failure rate was 4.3% and the subjective cure rate 73.9%. The objective cure rate for TVT-O group was 90%, the improvement rate was 7.6%, the failure rate was 2.5% and the subjective cure rate 76.7%. The hemoglobin loss ranged between 1.0 +/- 0.5 g/dl for TVT group and 0.9 +/- 0.4 g/dl for TVT-O group.
                The TVT-O technique presents success rates comparable to the classic TVT method in the short term. The efficacy, safety and hospital costs of the tension-free vaginal tape procedure were compared with the pubovaginal sling operation.
                A total of 60 women urodynamically diagnosed as having stress or mixed urinary incontinence were operated on using either the tension-free vaginal tape or pubovaginal sling operation in a prospective manner. Preoperative characteristics of the women were not significantly different for the groups. The women were followed for up to 24 months.
                In the tension-free vaginal tape group, the operation time was shorter, numbers of analgesics postoperatively required were less and hospital charges were less expensive compared to those in the pubovaginal sling operation (P < 0.01). Kaplan-Meier survival analysis showed a marginal significant difference (P = 0.059) in the objective cumulative cure rates at 24 months between the groups receiving the former (70.3%) and latter (48.3%) procedures. Subjective cure rates were not significantly different (P = 0.101). In both groups, an improvement in quality of life was significant and surgical complications were identical. De novo urge incontinence developed in 6% and 10% in the former and latter, respectively.
                The tension-free tape was significantly superior to the pubovaginal sling in terms of operation time, postoperative pain, and hospital charges, but not in cure rates. A longer follow up with a larger sample size is necessary to draw definite conclusions. Objective of the study was to compare the efficacy and the complications of tension-free vaginal tape (TVT) and Burch colposuspension in the treatment of female genuine stress incontinence (GSI).
                In this controlled, prospective, randomized study, participated 35 patients who underwent Burch colposuspension and 36 patients that underwent TVT procedure. Patients with prolapse more than first degree, previous surgical treatment of stress urinary incontinence (SUI) and detrusor instability were excluded from the study.
                The operative time for TVT was significantly shorter compared to BC. The severity and duration of postoperative pain for TVT was significantly less compared to BC. The necessary time for return to normal activity was 10 days for TVT and 21 days for BC. The cure rate after 24 months of follow-up was as follows: TVT: 84% and BC: 86%, while the improvement was 7% for TVT and 6% for BC.
                TVT and Burch colposuspension are equally effective in the management of female GSI at two years follow-up. TVT procedure requires much less operative time, has much shorter hospitalization time, with significantly less postoperative pain and faster return to normal daily activities than Burch colposuspension. The aim of our study was to test the hypothesis that elderly women undergoing tension-free vaginal tape surgery (TVT) will have a better quality of life (QOL) and satisfaction compared to non-treated women despite age- and technique-related potential morbidity.
                This multicenter, prospective, randomized, controlled trial enrolled a total of 69 women aged over 70 years who initially consented to be randomized to either undergo immediate TVT surgery or to wait for 6 months before submitting to the same surgery (control group). The main outcomes measured at every visit (pre-randomization, 8-12 weeks and 6 months) consisted of the Incontinence-Quality of Life (I-QOL) Questionnaire, the Patient Satisfaction Questionnaire and the Urinary Problems Self-assessment Questionnaire, among others.
                The analysis included 31 patients in the immediate surgery group and 27 subjects in the control group. Peri-operative complications in the immediate surgery group were bladder perforation (22.6%), urinary retention (12.9%), urinary tract infection (3.2%) and de novo urgency (3.2%). At 6 months, the mean I-QOL scores for the TVT and control groups were respectively 96.5 +/- 15.5 and 61.6 +/- 19.8 (P < 0.0001); mean Patient Satisfaction scores were respectively 8.0 +/- 2.7 and 2.0 +/- 2.4 (P < 0.0001); and mean Urinary Problems scores were respectively 4.5 +/- 4.3 and 11.6 +/- 3.5 (P < 0.0001).
                At 6 months post-randomization, the group of elderly women who underwent immediate TVT surgery showed a significant improvement in QOL, patient satisfaction and less urinary problems compared to the group of women waiting for the same surgery.
                (c) 2007 Wiley-Liss, Inc. To compare objective and subjective outcomes after the tension-free vaginal tape procedure (TVT) with laparoscopic mesh colposuspension as a primary treatment for female stress urinary incontinence. Objective outcome measures were stress test and 48-hour pad test.
                In 6 departments of gynecology in Finland, including 4 university teaching hospitals and 2 central hospitals, 128 women with urodynamic stress incontinence were randomly allocated to 2 treatment groups. Seventy were treated with TVT and 51 by means of laparoscopic mesh colposuspension. There were 7 dropouts. Inclusion criteria were history of stress incontinence, positive stress test, and urodynamic conformation of stress incontinence. Exclusion criteria were age older than 70 years, previous incontinence surgery, more than 3 episodes of urinary tract infection within the last 2 years, coincident other gynecological surgery, body mass index more than 32 kg/m(2), urethral closure pressure less than 20 cm H(2)O, and residual volume more than 100 mL in preoperative urodynamic evaluation. Assessment took place before treatment and at 12 months postoperatively with the cough stress test, Urge Score, 48-hour pad test, King's College Health Questionnaire, Visual Analog Scale, and Urinary Incontinence Severity Score.
                When negative stress test was used as criteria for cure, 85.7% of women in the TVT group and 56.9% in the laparoscopic mesh colposuspension group were objectively cured. Subject satisfaction was significantly better after the TVT procedure than after laparoscopic mesh colposuspension.
                Treatment with TVT results in higher objective and subjective cure rates at 1 year than treatment by means of laparoscopic mesh colposuspension. To compare the efficacy of surgically managing stress urinary incontinence (SUI) with tension-free vaginal tape (TVT) and autologous fascia lata pubovaginal sling (Lata).
                Sixty-seven patients suffering from SUI entered this prospective study. The patients were divided into two groups randomly, 48 in TVT group and 19 in Lata group. The average follow-up time post-operation was 20 months in TVT group and 37 months in Lata group.
                The operating time was (27 +/- 5) min in TVT and (125 +/- 13) min in Lata. The volume of blood loss during surgery was: (27 +/- 6) ml in TVT and (67 +/- 11) ml in Lata. The post-operative recovery period in the hospital was: TVT, 1.8 days and Lata, 7.2 days. The differences between the two groups for these three parameters were statistically significant (P < 0.01). The 3-month cure rate post-operations was 94% (45/48) for TVT and 95% (18/19) for Lata. The surgical complications included 1 case of vesical perforation and 2 cases of overactive bladder in TVT group.
                TVT and Lata are both effective and safe surgical treatments for stress urinary incontinence. TVT has the benefits of being minimally invasive with a shorter operating time and a quicker recovery for the patients. A disadvantage is that the tape used in TVT is expensive, making the operation rather costly. Lata on the other hand is cheaper and may result in fewer complications, but the operation is not as easy for the patient. The aim of this study was to compare laparoscopic colposuspension with tension-free vaginal tape (TVT) in terms of costs to the county.
                In a prospective, randomized study, we approached 270 consecutive women presenting for evaluation of stress urinary incontinence symptoms at one university hospital. Preoperatively, and at 1-year follow-up, the women underwent urodynamic evaluation, an ultra-short pad-test and completed a lower urinary tract symptoms questionnaire. We randomized 79 consenting, eligible women to either procedure; a 1-year follow-up examination was performed on 68/71 (96%) women that were available. The procedures were performed as described previously. Main outcome measures were all relevant costs for goods and services associated with the procedures.
                The baseline characteristics of the two groups were similar. The TVT procedure was performed significantly faster than the laparoscopic colposuspension, i.e. 44.9 +/- 14.2 min compared with 60.5 +/- 13.4 min (p < 0.0001). Even so, procedural costs were significantly lower for laparoscopic colposuspension than for TVT (euro 1273.4 compared with euro 1342.8 p < 0.001). At the 1-year follow-up visit, three women operated on with TVT and one operated on with laparoscopic colposuspension required re-operation for continuous stress urinary incontinence. One women operated on with TVT had her sling cut for bladder-emptying problems. Total costs, including re-operations were euro 1462.6 for a TVT procedure andeuro; 1314.5 for a laparoscopic colposuspension.
                In our hands, the laparoscopic colposuspension was less expensive to the county than the TVT procedure. To determine whether the tension-free vaginal tape (TVT) procedure affects the mechanics of voiding in women with genuine stress incontinence (GSI).
                Between July of 1997 and July of 1999, 116 women with GSI in the absence of pelvic prolapse underwent a randomized controlled study of TVT vs. modified Burch colposuspension. The trial was conducted by using a standardized protocol, including strict criteria for excluding preexisting bladder outlet obstruction (BOO). Urodynamic studies including free flowmetry, filling (provocative) and voiding cystometry, and 1-hour pad test were performed before and at least 1 year after the operation. The Blaivas and Groutz nomogram was used as another criteria to assess the pre- and postoperative BOO.
                Eighteen women were excluded from the study as a result of having preexisting BOO and an additional 8 were lost to follow-up. The comparison between pre- and postoperative variables for each procedure revealed that maximal flow rate of noninvasive uroflowmetry was significantly lower after operation in both groups (P = 0.009, P = 0.010, respectively). Detrusor pressure at maximal flow and urethral resistance were significantly higher and micturition volumes significantly lower after operation in the Burch group (P < 0.001, P < 0.001, P = 0.029, respectively). The difference between pre- and postoperative distribution of the obstruction nomogram of the Burch group was significantly different (P = 0.023).
                Based on strict exclusion criteria for preoperative BOO, our findings strongly suggest that with a median 22 months (range, 12 to 36 months) of follow-up, a properly performed tension-free vaginal tape procedure does not cause urethral obstruction.
                Copyright 2003 Wiley-Liss, Inc. To compare short-term functional outcomes, urodynamic parameters, and quality of life of transobturator and retropubic routes in the cure of urinary stress incontinence.
                This prospective, multicentre study involved 88 women undergoing suburethral sling procedure for stress urinary incontinence (SUI). The retropubic route (RPR) and the transobturator route (TOR) were used in 42 and 46 women, respectively. No difference in epidemiologic and preoperative urinary functional status (SUI stage, and pollakiuria, nocturia, and urgency rates) was found between the groups. Functional results and quality of life were evaluated before surgery and at 1, 3, 6, and 12 mo postoperatively. Urodynamic examinations were performed before and 3 mo after surgery.
                The mean follow-up was 10 mo. No difference in the rate of de novo urge incontinence and immediate and late voiding dysfunction was noted between the groups. No difference in the cure rate was observed between the groups (89.3% in the RPR group and 88.6% in the TOR group). RPR was associated with a significant decrease in maximum urinary flow and an increase in residual urine volume. Quality of life was significantly improved after surgery without difference between the groups.
                Retropubic and transobturator routes for treatment of female SUI have similar high cure rates and quality of life improvement. Because of advantages in the rate of complications and postoperative pain previously demonstrated on the same population, the transobturator route appears to be the best option for the treatment of urinary incontinence. The aims of this trial were to compare the attendant complications and postoperative voiding function of the Monarc and suprapubic arc (Sparc) suburethral sling procedures. This is the first article in English literature to compare different suburethral sling procedures using prosthesis of the same material and the same weave. Sixty women with urodynamic stress incontinence alone or combined with pelvic prolapse less than International Continence Society stage II were randomly allocated to either the Monarc or Sparc group. A comparison of the peri- and postoperative results comprising complications and symptoms of voiding function revealed no significant differences between the two groups in a follow-up ranged from 6 to 14 months (median, 9 months). However, the nonsignificant increase in tendency of inadvertent vaginal perforation and disability/pain of thigh (Monarc 12.9 vs Sparc 0.0%, p=0.112 and Monarc 12.9 vs Sparc 0.0%, p=0.112, respectively) has clinical significance. Based on the analyses of the comparison of Blaivas obstruction nomograms, postoperative voiding function was not significantly different between the two surgical groups. We concluded that Monarc and Sparc suburethral taping proved to be equally safe and posed no remarkable impact on voiding function in a short term postoperative follow up. However, intraoperative urethrocystoscopy is recommended for safety in both the Monarc and Sparc procedures. To compare the laparoscopic Burch colposuspension with the tension-free vaginal tape procedure (TVT) for efficacy.
                Seventy-two women from 2 institutions were randomized: 36 to laparoscopic Burch colposuspension and 36 to TVT. Multichannel urodynamic tests were performed preoperatively and 1 year after surgery. A research nurse administered the Urogenital Distress Inventory, Incontinence Impact Questionnaire, and pelvic examinations using the pelvic organ prolapse quantification system preoperatively, and at 6 months, 1 year, and 2 years after surgery. Voiding diaries were collected at 1 and 2 years. Primary outcome was objective cure, which was defined as no evidence of urinary leakage during postoperative urodynamic studies. Secondary outcomes included subjective continence, perioperative and postoperative data, and quality of life.
                Thirty-three laparoscopic Burch colposuspension and 33 TVT patients were analyzed with a mean follow-up of 20.6 +/- 8 months (range 12-43). Mean operative time was significantly greater in the laparoscopic Burch colposuspension group compared with the TVT group, 132 versus 79 minutes, respectively (P = .003). Multichannel urodynamic studies in 32 laparoscopic Burch colposuspension and 31 TVT patients showed a higher rate of urodynamic stress incontinence at 1 year in the laparoscopic Burch colposuspension group, 18.8% versus 3.2% (P = .056). There was a significant improvement in the number of incontinent episodes per week and in Urogenital Distress Inventory and Incontinence Impact Questionnaire scores in both groups at 1 and 2 years after surgery (P < .001). However, postoperative subjective symptoms of incontinence (stress, urge, and any urinary incontinence) were reported significantly more often in the laparoscopic Burch colposuspension group than in the TVT group (P < .04 for each category).
                The TVT procedure results in greater objective and subjective cure rates for urodynamic stress incontinence than does laparoscopic Burch colposuspension. The aim of this study was to compare the morbidity and short-term efficacy of retro-pubic (TVT) and inside-out trans-obturator (TVT-O) sub-urethral sling in the treatment of stress urinary incontinence. This was a prospective multi-centre randomised trial; 231 women with primary stress urinary incontinence were randomised to TVT (114) or TVT-O (117). The International Consultation on Incontinence-Short Form (ICIQ-SF), Women Irritative Prostate Symptoms Score (W-IPSS) and Patient Global Impression of Severity (PGI-S) questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on QoL and to measure the patient's perception of incontinence severity. The primary and secondary outcome measures were rates of success and complications. The SPSS software was used for data analysis. The TVT-O procedure was associated with significantly shorter operation time and with a more extensive use of general anaesthesia when compared with TVT. There were 5 (4%) bladder perforations in the TVT group compared with none in the TVT-O group. Rates of early post-operative urinary retention and voiding difficulty were similar for both groups and no difference was found in the average hospital stay. Six patients (5%) in the TVT-O group complained of thigh pain in the post-operative course. The median follow-up time was 6 months. Two hundred eighteen patients were available for the analysis of outcomes. Subjective and objective cure rates were 92% and 92% in the TVT group and 87% and 89% in the TVT-O group. The ICIQ-SF questionnaire symptoms score showed a highly statistical decrease in both groups, the W-IPSS on the contrary was unchanged. Our data show that both procedures were equally effective in the short-term for the treatment of stress urinary incontinence with a highly significant improvement in incontinence-related QoL. To compare laparoscopic Burch colposuspension and tension-free vaginal tape (TVT) procedure in women with genuine stress incontinence.
                Randomized clinical study (Canadian Task Force classification I).
                Tertiary care university hospital.
                Forty-six consecutive women.
                Laparoscopic Burch colposuspension (23) and TVT procedure (23).
                Valsalva leak-point pressure increased after surgery in both groups, but TVT substantially decreased maximum urinary flow rate. Other urodynamic studies showed no statistical differences. The groups did not differ significantly with respect to intraoperative complications or objective and subjective cure rates. Operating time was significantly longer for laparoscopic Burch (p = 0.001), and three patients in that group required conversion to laparotomy. Length of hospital stay (p = 0.003) and duration of catheterization (p = 0.003) were shorter in the TVT group.
                TVT holds promise in women with genuine stress incontinence, with several advantages over laparoscopic Burch. To compare the safety and efficacy of three types of suburethral slings for the treatment of urodynamic stress incontinence.
                Following ethics approval, 195 (3 x 65) patients with urodynamic stress incontinence were randomly assigned to undergo suburethral slingplasty with the Tension-free Vaginal Tape (TVT; Gynecare, Ethicon, Somerville, NJ, USA), Intravaginal Sling (IVS; Tyco Healthcare, Mansfield, MA, USA), or Suprapubic Arc Sling (SPARC; American Medical Systems, Minnetonka, MN, USA). The patients were blinded to the type of sling implanted. MAIN OUTCOME MEASURES WERE: (1) operative and short-term complications; (2) pre- and postoperative symptomatology; and (3) pre- and postoperative urodynamic findings.
                There was a statistically significant increased rate of sling protrusion (13.1% vs. 3.3% and 1.7%; P = 0.04) in the SPARC group when compared to TVT and IVS. Otherwise, there were no significant differences between the groups with respect to the incidences of other operative complications, patients' main subjective outcomes, satisfaction rates, or postoperative urodynamic findings. The overall objective stress incontinence cure rates were 87.9%, 81.5% and 72.4% for the TVT, IVS, SPARC groups respectively (P = 0.11).
                All three slings appear quite successful for the treatment of stress incontinence. The SPARC tapes showed more sling protrusion complications and a trend towards lower objective cure rates; probably as a result of the insertion method used in this study which favoured a loose SPARC sling placement. The authors recommend that the SPARC slings be left tighter than TVT, or for the cough test to be carried out. This study was undertaken to compare the efficacy and morbidity of 2 minimally invasive procedures for stress urinary incontinence.
                This was a prospective randomized multicenter trial; 190 women with primary urodynamic stress incontinence were randomly assigned to tension-free vaginal tape (TVT) (n = 95) or intravaginal slingplasty (IVS) (n = 95). The primary and secondary outcome measures were rates of success and complications. SPSS software was used for data analysis.
                At 2 years 92 and 87 patients were available in the TVT and IVS group for outcomes analysis. Subjectively, 80 (87%) and 68 (78%) women were cured, respectively. Objectively, a 1-hour pad test was negative in 78 (85%) and 63 (72%) patients. Eight of the patients assigned to IVS (9%) had vaginal erosion/infection, compared with none in the TVT group (P < .01).
                Both procedures were effective for stress incontinence, but 9% of women treated with the IVS required removal of the tape for erosions. To compare the cure rate and confirm the clinical efficacy of the 3 most frequently performed surgical procedures for stress urinary incontinence (SUI).
                Between January 2001 and May 2003, 92 women with SUI were randomly assigned to undergo the Burch colposuspension (n=33), pubovaginal sling (n=28), or tension-free vaginal tape (n=31) at the Department of Obstetrics and Gynecology, Yonsei Medical Center, Seoul, Korea. Patient characteristics, urodynamic study results, cure rates at 3, 6, and 12 months, and complication rates were compared using the chi2 test.
                There were no statistically significant differences in the cure rates initially, but after 12 months the cure rate of the pubovaginal sling procedure was found to be significantly higher than those of the tension-free vaginal tape or Burch colposuspension procedures.
                The cure rate of the pubovaginal sling procedure was significantly higher after 1 year, but no difference in efficacy was observed between the 2 other procedures. A randomized prospective study of a larger population should be conducted. The aim of this study was to prospectively compare the efficacy and safety of 'inside-out' (TVT-O) and 'outside-in' (TOT) transobturator tape procedures for treatment of female stress urinary incontinence (SUI). One hundred women with SUI were alternately assigned to TVT-O (n = 50) or TOT (n = 50). About 1 year after surgery, we compared surgical outcomes in the two groups. TVT-O and TOT showed similar rates of cure (86 vs 92%). Approximately 1 year after surgery, Incontinence Quality of Life questionnaire parameters improved significantly in both groups (p < 0.05), but the two groups did not differ (p > 0.05). The rates of patient satisfaction with TVT-O and TOT (96 vs 98%) were similar. These preliminary results suggest that TVT-O and TOT are equally effective and safe procedures for women with SUI. However, this study was unable to identify a difference between the two procedures due to the underpowered nature of the study. To compare tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVT-O) for surgical treatment of stress urinary incontinence (SUI) for complications (primary end point) and success rate (secondary end point).
                Seventy-two consecutive patients, with a mean age of 53.2 yr (range: 38-69 yr) and affected by SUI, were included in this randomised controlled trial. After preoperative assessment, patients were randomly allocated to the TVT or TVT-O procedure. Operative time, perioperative complications, and hospital stay were prospectively recorded. Cure of SUI was defined as no leakage of urine during the stress test at urodynamic testing at the 12-mo evaluation. The Wilcoxon signed rank sum test, Mann-Whitney U test, McNemar test, and Fisher exact test were used to verify statistical significance, set at p<0.05.
                All patients were evaluable at the 12-mo follow-up. The characteristics of patients were well balanced between groups after randomisation. The mean operative time was significantly shorter in the TVT-O group. Perioperative complications were significantly more common after the retropubic approach (5% and 27% in TVT-O and TVT groups, respectively, p<0.04). The groups did not differ significantly in intraoperative blood loss, hospital stays, and time to return to normal activities. Sixty-five patients (90%) were successfully treated for SUI 12 mo after the operation (89% and 91% for TVT-O and TVT groups, respectively).
                Both techniques appear to be equally effective in the surgical treatment of SUI. However, TVT-O had a shorter operative time and lower overall perioperative complication rate. We prospectively compared the efficacy and safety of tension-free vaginal tape and transobturator vaginal tape inside-out for female stress urinary incontinence.
                A total of 120 women with stress urinary incontinence were alternately assigned to the tension-free vaginal tape group (60) or the transobturator vaginal tape inside-out group (60). Preoperative evaluation included urodynamic study and a Korean version of the incontinence quality of life questionnaire. One year after operation the surgical result, patient satisfaction, incontinence quality of life questionnaire, long-term complications and uroflowmetry were evaluated in the 2 groups.
                Patient characteristics were comparable in the 2 groups. Mean +/- SD operative time was significantly shorter in the transobturator vaginal tape inside-out vs the tension-free vaginal tape group (11 +/- 1.4 vs 15 +/- 1.8 minutes). In the transobturator vaginal tape inside-out and the tension-free vaginal tape groups the rates of cure (86.8% and 86.8%), improvement (6.6% and 8.2%) and failure (6.6% and 5.0%, respectively) were similar. Incontinence quality of life questionnaire parameters 1 year after surgery were improved significantly in each group and there was no difference between the 2 groups (p <0.001 and >0.05, respectively). There was no long-term complication in either group. Preoperative urge incontinence resolved in 80% of the tension-free vaginal tape group and in 100% of the transobturator vaginal tape inside-out group. De novo urgency developed in 4 patients (6.6%) in the transobturator vaginal tape inside-out group.
                The tension-free vaginal tape and transobturator vaginal tape inside-out procedures were minimally invasive and similar in operation related morbidity. Transobturator vaginal tape inside-out appeared to be as effective and safe as tension-free vaginal tape for the surgical treatment of stress urinary incontinence in women at 1-year followup. The aim of the study was to compare the efficacy and complications of the Transobturator tape (Monarc) vs the tension-free vaginal tape obturator (TVT-O) in women with urodynamic stress incontinence. A prospective, randomized study was conducted. One-hundred and twenty patients were included in the study, and 114 of them were available at 12 months follow-up. Sixty-one patients were subjected to the TVT-O procedure and 53 to the Monarc procedure. Subjective and objective cure and improvement rate and complications incidence were assessed. The objective cure rate was 87% for the TVT-O procedure and 90% for the Monarc group. The subjective cure rate was 80% for the TVT-O group and 77% for the Monarc group. The improvement was 13 and 11.5% for the TVT-O and Monarc groups, respectively. There was one accidental injury to the urethra with the Monarc technique. The Monarc technique presents success rates and complications comparable to the TVT-O method at 1 year follow-up. To compare short-term results of autologous pubovaginal sling and synthetic transobturator (TOT) SAFYRE sling in the treatment of female stress urinary incontinence (SUI).
                Twenty women referred for surgical treatment of SUI were assigned randomly to autologous pubovaginal sling or synthetic TOT sling. Inclusion criteria were primary treatment of SUI and urodynamic study showing SUI without detrusor overactivity. Pre- and postoperative quantification of the severity of incontinence was done by pad test and a validated questionnaire (King's Health Questionnaire).
                There were no differences in patients' mean age, parity, body mass index, rate of postmenopausal state, pelvic floor defects and mean Valsalva leak point pressure in the preoperative urodynamic study. Mean operating time (21.1 +/- 3.8 vs. 69.5 +/- 23.7 min; P < 0.001) and hospital stay (28.8 +/- 8.4 vs. 44.4 +/- 5.8 h; P < 0.001) was shorter in the TOT than the autologous group. The postoperative pad test (39.4 +/- 12.5 vs. 8.4 +/- 5.2 g; P = 0.01) and the absent in the improvement in the quality of life were significantly higher in the TOT group.
                Our initial results suggest that the synthetic TOT technique had worse effectiveness for treating female SUI compared to autologous pubovaginal sling. Our objective was to compare monofilament and multifilament tapes positioned without tension at the midurethra for postoperative complications and cure rate. One hundred patients with stress urinary incontinence were randomly allocated into two study groups. Using identical surgical methodology, 50 patients had a monofilament tape inserted at the midurethra using the TVT delivery instrument, and another 50 a multifilament tape using the IVS delivery instrument. The only significant difference between the groups was in the incidence of postoperative urinary retention ( p=0.023). Ten patients from the monofilament group required longer than normal ('normal' means to the morning of the next day) catheterization, in contrast to only two from the multifilament group. The clinical efficacy of both procedures was equally high. Conclusions were that both tapes appear to be equally effective in the surgical treatment of SUI. The higher incidence of postoperative urinary retention in the monofilament group was most likely caused by the elastic feature of this tape. To establish the equivalence between the tension-free vaginal tape (TVT) and the suprapubic urethral support sling (SPARC). Approximately 35% of women have stress urinary incontinence (SUI), and although TVT is now perceived as the standard treatment, the SPARC is a very similar procedure and is thought to have fewer peri-operative complications.
                Patients with clinical SUI were recruited from public and private urology/urogynaecology clinics, and participated in the trial of TVT vs SPARC. The primary outcome was bladder perforation; secondary outcomes were blood loss, voiding difficulty, urgency, and cure of SUI symptoms. Sample size calculations, based on an estimated 2% perforation rate, showed that 290 patients would be needed to detect a clinically significant difference of 5%. Stratification was by previous incontinence surgery and the experience of the surgeon.
                There were 301 operations; the difference in bladder perforations was not statistically significant, at one/147 TVT (0.7%), and three/154 SPARC (1.9%), with the difference in rate of 0.013 (95% confidence interval (CI) - 0.01 to 0.04; odds ratio 2.89, 95% CI 0.30-28.21; P = 0.62), and nor were differences in estimated blood loss of >100 mL (TVT, 32/147, 21.8%; SPARC 28/154, 18.2%); de novo urgency (TVT 15/37, 40.5%; SPARC 14/33, 42.4%), objective cure (TVT 143/147, 97.3%; SPARC 148/152, 97.4%) or vaginal mesh erosion (TVT 7/147, 4.8%; SPARC 16/152, 10.5%). Acute urinary retention (TVT none of 147; SPARC 10/154, 6.5%; odds ratio infinity, 95% CI 2.2-infinity; P = 0.002) and subjective cure (TVT 128/147, 87.1%; SPARC 117/153, 76.5%; odds ratio 2.07, 95% CI 1.13-3.81; P = 0.03) were statistically significantly different.
                These results are consistent with clinical equivalence between TVT and SPARC for bladder perforation. There was no statistically significant difference between TVT and SPARC in blood loss, urgency or objective cure of SUI symptoms at 6 weeks. However, SPARC was more difficult to adjust correctly, and a statistically significant number of patients required loosening of the tape in theatre (P = 0.002). TVT had a lower rate of vaginal erosion and a statistically significantly higher cure rate of subjective SUI symptoms than SPARC. Overall, voiding difficulty (loosening of the tape), urgency and vaginal mesh erosion were the most important clinical problems. This trial showed the importance of testing new devices which appear to be similar, but which might have relevant differences. There was no financial assistance for this study, and a long-term follow up is planned. The aim of this randomized clinical trial was to compare the cure rate and the rate of complications of the tension-free vaginal tape (TVT) with those of the tension free vaginal tape obturator (TVT-O) procedure after one year of follow-up. The study was powered to show a ten per cent difference in cure rate and/or rate of complications. Of the initially treated 267 women 134 in the TVT group and 131 in the TVT-O group were evaluated. A cough stress test and a 24 h pad test were used as objective outcome measures. Subjective outcome was assessed by different condition-specific quality of life questionnaires and general health by the EQ-5D questionnaire. Objective cure rate was 95.5% in the TVT patients and 93.1% in TVT-O patients. Subjective cure rates showed significant improvement at one the year follow up in both groups. No significant differences in cure rates between groups were seen. The complication rate was equal in both groups. To compare tension-free vaginal tape with colposuspension as primary treatment for stress incontinence.
                Multicentred randomised comparative trial.
                Gynaecology or urology departments in 14 centres in the United Kingdom and Eire, including university teaching hospitals and district general hospitals.
                344 women with urodynamic stress incontinence; 175 randomised to tension-free vaginal tape and 169 to colposuspension
                Assessment before treatment and at six months postoperatively with the SF-36, the Bristol female lower urinary tract symptoms questionnaire, the EQ-5D health questionnaire, a one week urinary diary, one hour perineal pad test, cystometry, and, in some centres, urethral profilometry.
                23 women in the colposuspension group and 5 in the vaginal tape group withdrew before surgery. No significant difference was found between the groups for cure rates: 115 (66%) women in the vaginal tape group and 97 (57%) in the colposuspension group were objectively cured (95% confidence interval for difference in cure -4.7% to 21.3%). Bladder injury was more common during the vaginal tape procedure; postoperative complications, in particular delayed resumption of micturition, were more common after colposuspension. Operation time, duration of hospital stay, and return to normal activity were all longer after colposuspension than after the vaginal tape procedure.
                Surgery with tension-free vaginal tape is associated with more operative complications than colposuspension, but colposuspension is associated with more postoperative complications and longer recovery. Vaginal tape shows promise for the treatment of urodynamic stress incontinence because of minimal access and rapid recovery times; cure rates at six months were comparable with colposuspension.
The current evidence base suggests that minimally invasive synthetic suburethral sling operations are as effective as traditional suburethral slings, open retropubic colposuspension and laparoscopic colposuspension in the short term but with less postoperative complications. Objective cure rates are higher with retropubic tapes than with obturator tapes but retropubic tapes attract more complications. Most of the trials had short term follow up and the quality of the evidence was variable.