an increasing number of patients are developing pelvic floor laxity . because of the presence of many collateral health problems , all of which vastly increase the risks of surgery , minimally invasive operations are preferable for safety and quality of life .
furthermore , it is suggested that hysterectomy itself may be a cause of pelvic organ laxity , as the descending uterine artery is a major blood supply to the uterosacral and cardinal ligaments .
there is no clear evidence supporting the role of hysterectomy in improving surgical outcome . in 2005 , a new minimally invasive methodology that permits uterine conservation , the  tissue fixation system ( tfs )  was reported ( fig .  1 ) .
a 7-mm wide , non - stretch monofilament tfs tape is applied entirely via a single vaginal incision , thus avoiding perforation of suprapubic , or perineal skin .
like tvt ( tension - free vaginal tape ) , the tfs works by creating a foreign body collagenous tissue reaction that reinforces a weakened pelvic ligament .
it has been successfully applied to reinforce pelvic ligaments and fascias for cystocele , vault prolapse , and perineal body repair [ 2 , 4 , 5 ] and stress incontinence [ 6 , 7 ] , according to an anatomical classification .
the aim of this study was to assess the effectiveness and perioperative safety of the tissue fixation system ( tfs ) tensioned minisling used as a minimally invasive surgical repair in a day surgery clinic for the treatment of pelvic organ prolapse ( pop).fig .
the tfs consists of two anchors ( an ) joined by a polypropylene mesh tape ( t ) passing through a one - way trapdoor at each base , which allows tightening .
the anchor is released into the tissues by activating the tfs applicator button ( b ) the tissue fixation system ( tfs ) .
the tfs consists of two anchors ( an ) joined by a polypropylene mesh tape ( t ) passing through a one - way trapdoor at each base , which allows tightening .
the anchor is released into the tissues by activating the tfs applicator button ( b )
we studied prospectively 60 patients who had undergone 180 site - specific tfs pop operations on a day surgery basis between october 2008 and february 2010 at yokohama motomachi women s clinic luna .
this study was approved by the ethics committees of the yokohama motomachi women s clinic luna in 2006 . written informed consent was obtained from all patients .
the prolapse was staged according to the ics popq classification [ 9 , 10 ] as follows : 0no prolapse is demonstrated during maximal straining ; i 
the most distal portion ( leading surface ) of the prolapse is > 1  cm above the level of the hymen ( < 1  cm ) ; ii  the most distal portion ( leading edge ) of the prolapse is  1  cm proximal to or extends 1  cm through the plane of the hymen (  1  cm , but  + 1  cm ) ; iii  the most distal portion of the prolapse is > 1  cm below the hymen , but no further than 2  cm less than the tvl ( there is not complete vaginal eversion ; > + 1  cm , but < + [ tvl 2 ] cm ) ; iv  complete eversion of the vagina (  + [ tvl 2 ] cm ) .
we evaluated general quality of life ( qol ) affected by pop according to the prolapse quality of life ( p - qol ) questionnaire ( q)2 , at which point 1 is  not affected at all , 
point 3 is  affected considerably ,  and point 4 is  affected very much . 
the tfs ( tfs surgical , adelaide , australia ) is an adjustable sling device for stress urinary incontinence and pelvic organ prolapse ( fig .  1 ) .
it consists of two polypropylene 4 pronged plastic anchors attached to a non - stretch lightweight monofilament polypropylene mesh tape .
the anchors have a pull - out strength of approximately 2.5 to 3  kg each .
is a one - way tensioning system that uniquely shortens and reinforces laterally displaced ligaments and fascia to the correct anatomical position ( fig .  2 ) .
shortening an overstretched ligament allows proper function of any muscle that contracts against such a ligament , fig .  2 .
histology studies in rats demonstrated that the anchor is entirely covered with collagenous tissue within 2  weeks of implantation .
blue solid line : tape prior to tightening ; red broken lines : tape after tightening ; black broken lines : replaced organ , ligaments , and connective tissues .
blue solid line : tape prior to tightening ; red broken lines : tape after tightening ; black broken lines : replaced organ , ligaments , and connective tissues .
cl lax cardinal ligament patients were given hydroxyzine hydrochloride 25  mg and atropine sulfate 0.5  mg i.m . , and diclofenac sodium 50  mg p.r .
the operations were performed under local anesthesia ( la ) by two surgeons , using 1  % xylocaine 40  ml + physiological saline 160  ml + vasopressin 40 units .
all patients underwent implantation of 3 tfs tapes for repair of the cardinal ligament , the arcus tendineus fasciae pelvis ( atfp ) , and the uterosacral ligaments ( fig . 
cervical ring / cardinal ligament sling the anchors were put along the cardinal ligament beyond the lateral sulcus .
tfs u - sling the anchors were placed below the pubic ramus , extending onto the medial aspect of the obturator fossa , in the position of the atfp insertion .
usl tfs sling the anchors were placed approximately 2  cm distal from the insertion of the uterosacral ligaments ( usl ) into the sacrum tfs for pelvic organ prolapse ( pop ) .
cervical ring / cardinal ligament sling the anchors were put along the cardinal ligament beyond the lateral sulcus .
tfs u - sling the anchors were placed below the pubic ramus , extending onto the medial aspect of the obturator fossa , in the position of the atfp insertion .
usl tfs sling the anchors were placed approximately 2  cm distal from the insertion of the uterosacral ligaments ( usl ) into the sacrum first , we performed a cardinal ligament tfs sling for restoration of the cardinal ligament / cervical ring defect ( also known as the  transverse defect  ) ( fig . 
the surgical principle underpinning this operation is similar to that of a manchester repair , except that the tfs also re - attaches the cervix to the pelvic side wall ( fig . 
the one - way tensioning system of the anchors shortened and re - attached the elongated and laterally displaced cardinal ligament to the anterior part of the cervix and pelvic side wall .
the tissue reaction generated by the tape  reglued  the pubocervical fascia to the anterior cervical ring .
a 2.5- to 3-cm horizontal incision was made in the vesical fold 1  cm above the cervix .
the bladder was dissected clear of the vagina and cervix . using dissecting scissors with the tips everted and firmly applied to the vagina
the tfs applicator was inserted into the tunnel and the anchor released . after waiting 10  s to allow rebound elastic closure of the tunnel , the tape was tugged laterally to set the anchor .
the tape was tightened until a resistance was felt , indicating return of muscle contractility .
the surgical principle underpinning this operation is to reinforce the atfp ( arcus tendineus fasciae pelvis ) , re - attach the pubocervical fascia to the atfp ( correction of the lateral defect ) , and to provide a transverse neofascial 
pressed against the vagina , again under tension , a channel was made below the pubic ramus , extending onto the medial aspect of the obturator fossa , in the position of the atfp insertion .
the applicator and anchor / tape were inserted and tightened as described previously . finally , the uterosacral ligament ( usl ) tfs sling operation was performed ( fig . 
the surgical principles underpinning this operation are to use the one - way tensioning system of the anchors to shorten the laterally displaced uterosacral ligaments , lift the uterus back into its original anatomical position ( fig . 
2 ) , and using the tissue reaction generated by the tape , to  reglue 
the uterosacral ligaments ( usls ) or their remnants were identified and grasped with allis forceps .
then , under tension , scissors angled at 30 perforated the uterosacral ligaments approximately 2  cm distal to their insertion points to the sacral bone in a tunnel sufficiently wide to accommodate the tfs applicator .
the applicator and anchor / tape were inserted and tightened as described previously . blood loss was measured in milliliters from the suction bottle and preweighed swabs .
the primary outcome measure was re - assessment of the patient by vaginal examination using the popq system at 3 , 6 , and 12  months .
we defined surgical failure where points ba , bp or c , the distal portion ( leading surface ) of the prolapse were > 1  cm above the level of the hymen during straining .
secondary outcome measures were symptom change , blood loss , and report of complications . the results as reported concern only the 12-month review , which included the questionnaires .
patient characteristics and symptoms were summarized using descriptive statistics for continuous variables presented with means and standard deviations as appropriate .
surgical failure ( relapse ) was defined as the presence of prolapse stage 2 or more in the middle compartment with prolapse complaints and/or redo surgery at 1-year follow - up according to the popq classification .
, japan ) to assess statistical significance at the two - sided 5  % level ( p  <  0.05 ) .
patients were given hydroxyzine hydrochloride 25  mg and atropine sulfate 0.5  mg i.m . , and diclofenac sodium 50  mg p.r .
the operations were performed under local anesthesia ( la ) by two surgeons , using 1  % xylocaine 40  ml + physiological saline 160  ml + vasopressin 40 units .
all patients underwent implantation of 3 tfs tapes for repair of the cardinal ligament , the arcus tendineus fasciae pelvis ( atfp ) , and the uterosacral ligaments ( fig . 
cervical ring / cardinal ligament sling the anchors were put along the cardinal ligament beyond the lateral sulcus .
tfs u - sling the anchors were placed below the pubic ramus , extending onto the medial aspect of the obturator fossa , in the position of the atfp insertion .
usl tfs sling the anchors were placed approximately 2  cm distal from the insertion of the uterosacral ligaments ( usl ) into the sacrum tfs for pelvic organ prolapse ( pop ) .
cervical ring / cardinal ligament sling the anchors were put along the cardinal ligament beyond the lateral sulcus .
tfs u - sling the anchors were placed below the pubic ramus , extending onto the medial aspect of the obturator fossa , in the position of the atfp insertion .
usl tfs sling the anchors were placed approximately 2  cm distal from the insertion of the uterosacral ligaments ( usl ) into the sacrum first , we performed a cardinal ligament tfs sling for restoration of the cardinal ligament / cervical ring defect ( also known as the  transverse defect  ) ( fig . 
the surgical principle underpinning this operation is similar to that of a manchester repair , except that the tfs also re - attaches the cervix to the pelvic side wall ( fig . 
the one - way tensioning system of the anchors shortened and re - attached the elongated and laterally displaced cardinal ligament to the anterior part of the cervix and pelvic side wall .
the tissue reaction generated by the tape  reglued  the pubocervical fascia to the anterior cervical ring .
a 2.5- to 3-cm horizontal incision was made in the vesical fold 1  cm above the cervix .
the bladder was dissected clear of the vagina and cervix . using dissecting scissors with the tips everted and firmly applied to the vagina
the tfs applicator was inserted into the tunnel and the anchor released . after waiting 10  s to allow rebound elastic closure of the tunnel , the tape was tugged laterally to set the anchor .
the tape was tightened until a resistance was felt , indicating return of muscle contractility .
the surgical principle underpinning this operation is to reinforce the atfp ( arcus tendineus fasciae pelvis ) , re - attach the pubocervical fascia to the atfp ( correction of the lateral defect ) , and to provide a transverse neofascial 
beam  to reinforce the damaged central pubocervical fascial defect . keeping the scissors pressed against the vagina , again under tension
, a channel was made below the pubic ramus , extending onto the medial aspect of the obturator fossa , in the position of the atfp insertion .
the applicator and anchor / tape were inserted and tightened as described previously . finally , the uterosacral ligament ( usl ) tfs sling operation was performed ( fig . 
the surgical principles underpinning this operation are to use the one - way tensioning system of the anchors to shorten the laterally displaced uterosacral ligaments , lift the uterus back into its original anatomical position ( fig . 
2 ) , and using the tissue reaction generated by the tape , to  reglue 
the uterosacral ligaments ( usls ) or their remnants were identified and grasped with allis forceps .
then , under tension , scissors angled at 30 perforated the uterosacral ligaments approximately 2  cm distal to their insertion points to the sacral bone in a tunnel sufficiently wide to accommodate the tfs applicator .
the applicator and anchor / tape were inserted and tightened as described previously . blood loss was measured in milliliters from the suction bottle and preweighed swabs .
the primary outcome measure was re - assessment of the patient by vaginal examination using the popq system at 3 , 6 , and 12  months .
we defined surgical failure where points ba , bp or c , the distal portion ( leading surface ) of the prolapse were > 1  cm above the level of the hymen during straining .
secondary outcome measures were symptom change , blood loss , and report of complications . the results as reported concern only the 12-month review , which included the questionnaires .
patient characteristics and symptoms were summarized using descriptive statistics for continuous variables presented with means and standard deviations as appropriate .
were assessed by a pop - q examination considered to be the primary outcome . surgical failure ( relapse )
was defined as the presence of prolapse stage 2 or more in the middle compartment with prolapse complaints and/or redo surgery at 1-year follow - up according to the popq classification .
, japan ) to assess statistical significance at the two - sided 5  % level ( p  <  0.05 ) .
fifty - four patients ( a response rate of 90  % ) agreed to attend for 12-month review .
the average patient age was 67  years ( range 44 to 87  years ) .
levels of pop were stage 2 ( n  =  20 ; 37  % ) , stage 3 ( n  =  30 ; 55  % ) , and stage 4 ( n  =  4 ; 7  % ) .
average operative time was 86  min ( minimum 40  min , maximum 135  min ) and average blood loss 21  g. ( minimum 4  g , maximum 136  g ) .
fifty - three patients ( 98  % ) were discharged on the day of surgery .
one patient with a hematoma was transferred to a neighboring hospital for observation purposes only .
the total number of patients who had no complications , no symptoms of bulging , no surgical failures , no erosions , and no cervical protrusions was 47 ( 87  % ) .
in addition , 2 patients developed cervical protrusions at the introitus 6  months after tfs surgery .
there was no prolapse of the uterine body ; thus , only the elongated cervix was amputated .
we found 2 cases of tape erosion and 3 tape / anchor extrusions associated with prolapse relapse in a total of 162 operations .
we believe that 3 of the surgical failures were caused by inadequate application of the anchor , resulting in slippage and erosion of the tape .
four of the 5 failed cases underwent re - operation and were cured by tfs pop operations .
there were statistically significant improvements in pollakisuria ( urinary frequency ) , urgency , urge urinary incontinence , and stress urinary incontinence .
the average score of p - qol q2qol affected by pop  changed between pre- and post - operation from 3.77    0.78 to 2.44    0.61 ( p  <  0.01).table 1improvement in urinary - related qolnumber of p - qolsymptomaverage points  sd ( pre - operation)average points  sd ( post - operation after 1  year ) 
 p valueq3pollakisuria ( urinary frequency)3.34    1.042.74    0.79 <  0.01q4urgency3.05    0.992.66    0.67 <  0.05q5urge urinary incontinence2.89    0.832.62    0.67 <  0.05q6stress urinary incontinence3.22    0.972.82    0.79 <  0.05 improvement in urinary - related qol
this is the first report of tfs pop repair under local anesthesia ( la ) with same - day patient discharge .
the local anesthetic surgical technique we used was made possible by the minimally invasive nature of the tfs system and its anatomical accuracy .
they are ideally suited to older women as there is minimal disruption of activities and because the surgical methodology minimizes serious post - operative complications such as deep vein thrombosis , pulmonary embolism , and complications from the intercurrent diseases associated with old age .
of course an arrangement with neighboring hospitals is required for patient transfer in the case of an emergency . the primary outcome result on a patient operated basis ( no complications , no surgical failures , no symptoms of bulging , no erosions , no cervical protrusions ) was 87  % .
this compares favorably with those of a large rct for cystocele reported by altman et al .   who reported the primary outcome results ( popq staging 01 plus no symptoms of prolapse ) of 60.8  % in women treated with transvaginal mesh repair ( n  =  200 ) compared with 34.5  % in women treated with native tissue colporrhaphy ( n  =  189 ) .
mean operating time for our patients was 86  min for three site - specific tfs operations compared with 56  min for the cystocele mesh repair ; our patients lost slightly less blood and there were no bladder perforations .
the eroded tfs tapes did not require surgical re - intervention : rather , the eroded part was trimmed , like an eroded tvt tape .
we attribute our high cure rate to the novel surgical methodology of the tfs , which requires accurate diagnosis and precise anatomical restoration of damaged ligaments .
the cardinal and uterosacral ligaments are the principal ligamentous supports of the uterus and these insert into the cervical ring .
also , attached to the cervical ring is the pubocervical fascia ( pcf ) anteriorly and the rectovaginal fascia (  rvf  or 
the rvf inserts distally into the perineal body , and proximally into the cervical ring and levator plate muscles .
normal fascial attachments between organs and the suspensory ligaments allow the pelvic muscles to stretch the upper part of the vagina and the uterus downward and backward for normal support and function of the organs .
childbirth , age , and congenital collagen defects are major causes of the breakdown of this mechanism . the baby s head descending down the vagina stretches the connective tissue supporting structures ( ligaments and fascia ) laterally , thereby causing laxity .
lateral displacement of ligaments and associated connective tissues may cause the bladder , uterus , and rectum to herniate through the levator hiatus as a cystocele , uterine prolapse , rectocele , with or without urinary and bowel symptoms [ 8 , 12 ] .
we attribute symptom improvement to the tensioning properties of the tfs , which restores the laterally displaced pelvic ligaments and fascias to their former condition , thereby restoring not only organ support , but function ; also , because the tfs tape traverses the levator hiatus transversely , as well as creating artificial collagenous neoligaments , we hypothesize that it  re - glues  the organs to the levator hiatal muscles , as demonstrated previously in experimental animals .
this would limit the lateral  ballooning  of the hiatal muscles observed during straining .
the importance of collagenous attachments of the organs to levator hiatus was first described by robert zacharin in 1963 . in 1997 ,
the infracoccygeal sacropexy , also known as the posterior - ivs ( pivs ) , a minimally invasive procedure for the restoration of uterine or apical prolapse , was introduced .
importantly , it preserved the uterus . however , pivs operation was not entirely anatomical , as it attached the apex to the levator muscles / sacrospinous ligament ( ssl ) rather than to the uterosacral ligaments , which were sited some 3  cm cranial to the ssls . nor did the pivs address anterior vaginal wall defects , leading to anterior wall prolapse ( cystocele ) in 16  % of patients , and it did not re - attach the organs to the levator hiatus .
we believe that one factor in the tfs attaining a higher cure rate than large mesh is the potential ability of the tfs to re - attach the organs to the hiatus .
all tfs sling operations are a direct evolution of the tvt procedure , in that they work by using only a short thin tape applied through a tunnel . by using the tfs , we were able to reinforce the cardinal ligament , pubocervical fascia , atfp and uterosacral ligaments , all major supports of the uterus and the anterior and posterior vaginal walls .
the tfs sling s unique ability to tension , shorten , and reinforce weakened elongated ligaments ( fig . 
2 ) , was an important factor in restoring the tension needed for the muscle forces to be able to restore function , as no muscle can contract efficiently against a loose connective tissue insertion . a cystocele may reoccur , or occur de novo following repair of uterine prolapse , even when a cystocele repair is performed at the same time by anterior colporrhaphy [ 11 , 17 ] .
because of this , many surgeons prefer to insert large meshes into the organ spaces to prevent organ descent
. this  glues  the vagina to the bladder or rectum , causing scarring and contraction , and preventing distension during intercourse , all major causes of the dyspareunia reported with large mesh insertion [ 11 , 19 ] .
large volumes of mesh lead to more scarring , erosions , infections , hematomas , even organ perforation and fistulas , ultimately resulting in the recent fda warnings of major complications with such meshes . the tfs method uses a different bioengineering approach to that of large mesh implants : reinforcing existing suspensory ligaments with a precisely inserted tape via a tunnel adjacent to the ligament . the scar tissue created by tissue reaction to the implanted tape reinforces the damaged ligament .
this explains how we were able to cure even 4th degree pops using small thin lengths of tape .
tensioning the tape provides strength in the manner of a wire suspension bridge ; spanning with tapes ( fig . 
3 ) reinforces the anterior vaginal wall like joists of a ceiling reinforcing a plasterboard . unlike large sheets of mesh ,
thus , antero - posterior elasticity is largely maintained , allowing the antero - posterior movements so important for efficient vesico - urethral and anorectal closure ( continence ) and evacuation .
adhesions are also potent causes of dyspareunia , as they prevent the vagina from stretching independently of the rectum .
we believe that failure in 5 cases was due to a loose tape caused by incorrect placement of the anchor . this may have been because of learning curve issues , or weak pelvic connective tissues .
because the subsequent tfs surgery was successful , we attribute the failure to the former , surgical error . our erosion rate ,
5 per 162 tapes implanted , is consistent with published erosion rates for the tvt .
it is also consistent with the differentiation between mid - urethral tapes for urinary stress incontinence ( acceptable ) and large mesh for pop ( questionable ) according to the recent 2011 warning by the fda .
the tfs applies the same surgical principle for repair as the tvt , whereby a thin polypropylene tape is placed in a tunnel to reinforce a damaged ( pubo - urethral ) ligament .
unlike native tissue repairs , which remove and suture centrally bulging defects , the tfs conserves vaginal tissue , attaches the organ to the pelvic side wall and to the hiatus .
its one - way system shortens the elongated ligaments to elevate the organ . because the tape inserted is of such a small volume
, the risk of erosion , contraction , dyspareunia , and system malfunction are likely to be decreased .
 introduction and hypothesisin 2005 , a new minimally invasive procedure , the tissue fixation system ( tfs ) was reported . 
 like tvt ( tension - free vaginal tape ) , the tfs works by creating a foreign body collagenous tissue reaction that reinforces a weakened pelvic ligament . 
 the objective was to assess the effectiveness and perioperative safety of tfs in a day surgery clinic for the treatment of pelvic organ prolapse ( pop).methodsthe tfs tape was applied in a tunnel adjacent to natural ligaments to repair the anterior cervical ring and cardinal ligament , paravaginal tissues and uterosacral ligaments under local anesthesia / sedation.we prospectively studied 60 patients , mean age 67 , between october 2008 and february 2010 at women s clinic luna . 
 levels of pop were grade 2 ( n  =  20 ; 7  % ) , grade 3 ( n  =  30 ; 55  % ) , and grade 4 ( n  =  4 ; 7  % ) according to the ics popq classification . 
 fifty - four patients ( 90  % ) who underwent a total of 162 pop operations presented for review . 
 follow - up was performed at 12  months . 
 we defined surgical failure according to the ics popq classification . 
 we used prolapse quality of life ( p - qol ) questions for qol measurement.resultsninety-eight percent of patients were discharged on the day of surgery . 
 of the162 tfs operations reviewed , 157 were successful and 5 failed . 
 the 5 failed operations comprised 4 cystoceles and 1 rectocele . 
 two patients developed cervical protrusions at the introitus at 6  months with no prolapse of the uterine body . 
 we found 5 cases of erosion in 162 tape insertions . 
 the total number of patients who had no complications , no surgical failures , no erosions , no sensation of bulging , and no cervical protrusions was 47 ( 87  % ) .conclusionsthe tfs uses the same surgical principle for repair as the tvt ; this principle vastly minimizes the volume of mesh used , erosions , and other complications . 
Introduction
Materials and methods
Local anesthetic technique
Surgery
Outcome measures
Data analysis and statistics
Results
Discussion
Conclusions
Conflicts of interest