Transobturator TVT-O versus

ORIGINAL ARTICLETransobturator TVT-O versus retropubic TVT:results of a multicenter randomized controlled trialat24months follow-upXavier Deffieux&Nagib Daher&Aslam Mansoor&Philippe Debodinance&Joël Muhlstein&HervéFernandezReceived:7February2010/Accepted:28May2010/Published online:16June2010#The International Urogynecological Association2010AbstractIntroduction and hypothesis The purpose of this study is to compare the retropubic tension-free vaginal tape(TVT) procedure with the inside-out transobturator approach (TVT-O).Methods Multicenter randomized controlled trial.One hundred forty-nine patients were randomly allocated to either TVT(n=75)or TVT-O(n=74).Interview,medical examination,pain scores,success rates,and quality of life assessment were recorded pre-operatively,and2,6,12,and 24months post-operatively.Results One hundred forty-nine patients underwent surgery, and132completed a24-month follow-up.Bladder injury rate was5%(4/75)in the TVT group and2%(2/74)in the TVT-O group(p=0.68).There was no significant difference between the two groups,concerning overall cure rate and the patients' satisfaction rate at24months follow-up.The range of mean pain scores was significantly higher after the TVT-O procedure post-operatively but not at24months follow-up. Conclusion TVT and TVT-O procedures both have an outcome associated with an increase in quality of life with no significant differences in satisfaction rates at2years follow-up.Keywords Incontinence.Sling.Tension-free vaginal tape. T-O.Urinary stress incontinence AbbreviationsICS International Continence SocietyMUCP maximum urethral closure pressureX.DeffieuxUniv Paris-Sud,Le Kremlin Bicêtre94270,FranceX.DeffieuxAP-HP,Service de Gynécologie-Obstétrique et Médecine de la Reproduction,Hôpital Antoine Béclère,Clamart92141,FranceN.DaherService de Gynécologie-Obstétrique,CHU Amiens, Amiens80054,FranceA.MansoorService de Gynécologie-Obstétrique,Centre Hospitalier Paul-Ardier,Issoire63500,FranceP.DebodinanceService de Gynécologie Obstétrique,Centre Hospitalier de Dunkerque,Saint-Pol-sur-Mer59430,France J.MuhlsteinService de Gynécologie Obstétrique,MaternitéRégionale Universitaire,Nancy54045,FranceH.FernandezAP-HP,Service de Gynécologie-Obstétrique,CHU Bicêtre, Le Kremlin Bicêtre,94275FranceH.FernandezInserm U822,Le Kremlin Bicêtre,FranceX.Deffieux(*)Service de Gynécologie Obstétrique,Hôpital Antoine Béclère, 157,rue de la Porte-de-Trivaux,92140Clamart,Francee-mail:xavier.deffieux@abc.aphp.frInt Urogynecol J(2010)21:1337–1345 DOI10.1007/s00192-010-1196-zTVT tension-free vaginal tapeTVT-O transobturator vaginal tapeUSI urinary stress incontinenceIntroductionUlmsten and Petros reported on the tension-free vaginal tape(TVT)mid-urethral retropubic procedure in1995and 1996.At the present time,mid-urethral sling procedures are considered to be the first-line technique for the surgical management of urinary stress incontinence(USI)in women.The TVT procedure is known to be associated with a high short-and long-term cure rate,between80% and90%[1].Because of the retropubic passage,the TVT procedure is associated with a relatively high risk of bladder perforation(2.7%to17%)and a rare risk of bowel or iliac vessel injury.Delorme thus reported an outside-in transobturator approach[2],and more recently,De Leval developed an inside-out transobturator sling technique (TVT-O)[3].These transobturator approaches decrease the risk of bladder or bowel injury.However,these new procedures are associated with specific risks and complica-tions,such as thigh pain and abscess[4].The randomized controlled trial reported here was designed to compare the retropubic TVT and transobturator TVT-O procedures(both using the same macroporous monofilament polypropylene sling),with emphasis being placed on cure rates and intraoperative and post-operative complications,with a minimum follow-up of24months. MethodsFrench National Ethical Committee approval(Comitéde protection des personnes,CPP–Hôpital Tarnier Cochin,Paris, France;no.2207/15-11-04)was obtained.Written informed consent was obtained from each woman.This trial was registered with the French national trials registry(AFSSAPS R130202361FR),with the French data protection authority(CNIL no.05.427),and with the international trials registry (/; identifier:NCT00135616),before the begin-ning of patient enrolment.Gynecare(Johnson and Johnson,Ethicon)had no role in the design,implementation,or analysis of this study or in the writing of the present publication.Fourteen centers in France(university hospitals and three general hospitals)participated in the clinical trial.All study surgeons had substantial experience with TVT and TVT-O procedures before enrolling the patients.From January2005to December2007,154women have been recruited,and149were randomly assigned to either the TVT or the TVT-O procedure.The patients were randomized using sealed opaque envelopes,following computer-generated random allocations,with a ratio of 1:1in balanced blocks of four.The envelopes were opened just before each participant's surgical procedure.The sample size calculation(SPSS analysis)was performed assuming a bladder injury rate of8%for TVT and0.5%for TVT-O.Withαequal to5%and80%power(1-β)the sample size should be180patients,with90patients in each group,to reveal a7.5%difference.The number of subjects included in the trial did not reach this figure because of insufficient enrolment in some centers.Inclusion criteria were as follows:isolated or mixed USI (according to the International Continence Society(ICS) classification[5],indication for surgical treatment of USI, positive cough stress test(cough stress test was performed during cystometry in sitting position;volume200to 300ml),and at least18years of age.Exclusion criteria were as follows:concomitant pelvic organ prolapse surgery, concomitant hysterectomy,previous incontinence surgery, pregnancy,anticoagulant therapy,higher than first stage urogenital prolapse(POP-Q ICS),and patient unable to understand the purpose of the trial.The method of anesthesia was left to the discretion each surgeon.Retropubic TVT procedures were all performed using the vaginal approach,in accordance with the technique described by Ulmsten and the manufacturer (Johnson and Johnson,Ethicon,Gynecare).The TVT-O (Johnson and Johnson,Ethicon,Gynecare)procedures were all performed using the vaginal approach,from inside to outside,as described by Jean de Leval[3].The vaginal incision was made in the same fashion in both groups.The polypropylene sling was identical in both procedures,and commercially available TVT and TVT-O kits were used(Johnson and Johnson,Ethicon,Gynecare). For both procedures,the surgeons were instructed to place the slings“tension-free.”Beyond this,no other standard-ization of the sling tension was imposed.No per-operative cough stress test was required.All patients,including those in the TVT-O group,underwent an intraoperative cystoscopy to check for the presence of lower urinary tract injury.The operative time was measured from the opening to the closing of the vaginal mucosa and included the duration of the cystoscopy.At baseline,all participants underwent a standardized evaluation,which included a urogynecological history, pelvic organ prolapse quantification examination,and a urodynamic evaluation.The presence of bladder outlet obstruction symptoms was identified during the interview by the presence of one or several altered emptying symptoms:hesitancy,slow orintermittent stream,and straining or feeling of incomplete emptying.The urodynamic evaluation(carried out following the laboratory's standard procedure,in agreement with Interna-tional Continence Society recommendations),was performed pre-operatively and at12-months follow-up,and included uroflowmetry,a filling cystometrogram,and a maximum urethral pressure measurement.At2,6,12,and24months, all participants underwent a urogynecological examination. The validated CONTILIFE[6]questionnaire was completed pre-operatively,and at the2,6,12,and24-months follow-up visits,for condition-specific assessment.Visual analog scales (V AS0-100)for sexual well-being and satisfaction with the operation were also used at the2-,6-,12-,and24-month follow-ups.Blinding of the surgeon or the participants was not possible post-operatively because of the different incisions required for each procedure(shamed incisions are not ethically justified).Post-void residual urine volumes were measured by catheterization following spontaneous voiding.Post-operative pain was assessed at hospital discharge,post-operatively after1and3weeks,and2,6, 12,and24months,using visual analog scales(V AS0-100).“De novo urgency”is defined by the appearance of urge symptoms post-operatively.Objective(negative stress test)and subjective(no referred leakage at interview,no use of protection)cure rates were recorded at2,6,12,and24months follow-up.The overall cure rate was defined as follows:no urine leakage and negative stress test.Follow-up examinations were performed in supine position(bladder full)by operating surgeons.Satisfaction rate was assessed using visual analog scale ranging from0(very unsatisfied)to100(very satisfied).Descriptive data are given as follows:mean and SD (standard deviation)or median and interquartile range (IQR:25th–75th percentile).Primary and secondary out-comes were compared,as appropriate,with the Fisher exact test for categorical data and the Wilcoxon rank-sum test for continuous data.ResultsA flow chart is provided in Fig.1.Five women withdrew from the study before randomization and were not included in the analysis.Patient demographics are reported in Table1.After randomization,the patients'characteristics, including age,body mass index,percentage of mixed incontinence,and intrinsic sphincteric deficiency(MUCP <30cm H2O)were well-balanced between the two groups (see Table1).The procedures were carried out under local,regional,or general anesthesia,in accordance with the protocol of each center.There was no difference between the two groups concerning the method of anesthesia.A local or locore-gional anesthesia was performed in45/74(61%)versus 47/75(63%)of cases,in the TVT-O and TVT groups, respectively(p=0.46).The mean operative time was18.7min in the TVT-O group and20.3min in the TVT group(p=0.26). Bladder injury and other per-operative complicationsThe bladder injury rate was5%(4/75)in the TVT group and2%(2/74)in the TVT-O group(p=0.68).Each case of bladder injury was diagnosed during the per-operative cystoscopy.All such injuries were observed in the left side of the bladder,and all of the surgeons who caused them were right-handed.One(1/75,1%)urethral injury was observed in the TVT group and was treated by suturing and indwelling catheter-ization for a period of5days.One(1/74,1%)vaginal extrusion(erosion)of the sling occurred at2months follow-up in the TVT-O group and required reintervention for resection of the protruding part of the sling.No recurrence of urinary incontinence was observed in this case.No other major complication occurred,such as bowel perforation,blood transfusion,or hematoma.Repeat surgery(reintervention)Finally,by24months follow-up,only three patients required repeat surgery.Sectioning of the sling was required at respectively2and6months follow-up,for two patients in the TVT group,as a result of persistent bladder outlet obstruction symptoms and a major post-void residual volume and was required at2months follow-up for one patient in the TVT-O group,as a result of vaginal sling extrusion.Post-operative urinary symptomsAt2,6,12,and24months follow-up,no difference was observed between the two groups concerning symptoms of frequency,nocturia,de novo voiding difficulties or de novo urgency.The median(IQR)discomfort associated with bladder outlet obstruction symptoms was5/100(0–20),versus 10/100(0–20),at24months follow-up in the TVT-0and TVT groups,respectively(p=0.66).Eight patients required self-catheterization after more than48h:2/74following the TVT-O procedure and6/75 following the TVT procedure(p=0.27).The mean duration of intermittent catheterization was12days(±13).At 2months follow-up and thereafter,no patient required intermittent catheterization.Success rate and patients'satisfaction with the procedure Objective and subjective cure rates at 6,12,and 24months follow-up are provided in Table 2.There was no significant difference between the TVT and TVT-O groups.There was no significant difference between the two groups concerning global satisfaction rate,at 2,6,12,and 24months follow-up.Median satisfaction rate was 89.3/100vs 87.1/100at 12months follow-up and 87.7/100vs 86.1/100at 24months follow-up in TVT and TVT-O group,respectively (p=0.66).Fig.1Flow chart describing the progress of patients.Abbreviations:TVT tension-free vaginal tape,TVT -O inside-out transobturator mid-urethral sling techniqueIn patients presenting with severe intrinsic sphincteric deficiency (MUCP<20cmH20),the recurrence rate of urinary incontinence was 50%(2/4)in TVT-O group and 25%(1/4)in TVT group (p=1).In patients presenting with MUCP<30cmH 2O,the recurrence rate of urinary incontinence was 40%(4/10)in TVT-O group and 37%(3/8)in TVT group,respectively (p=1),at 24months follow-up.Pain scoresPre-operatively,in both groups,8%of the women reported chronic pelvic pain before surgery,with over 30%on the V AS.The level of the mean pain scores was significantly higher following the TVT-O procedure,post-operatively,and at 2months follow-up,but any significant difference disappeared at 6,12,and 24months follow-up.When considering the percentage of patients presenting with higher pain scores (>30/100on the V AS),the level of post-operative pain increased significantly in the TVT-O group,1week,3weeks,and 12months post-operatively.However,the difference between the groups disappeared at 24months follow-up.At 24months follow-up,four patients in the TVT-O group and two patients in the TVT group complained of pain over 30/100on the V AS.Among them,three (50%)complained of chronic pelvic pain over 30%on the V AS,before surgery.In the TVT-O group,the pain was located in the thigh in one case,in the pelvis in two cases,and in the vagina and suprapubic space in one case.In the TVT group,the two patients complained of suprapubic pain.Urodynamic dataPre-operative and 12months post-operative urodynamic evaluations are provided in Table 3.The post-voiding residual volume was significantly increased following the TVT procedure.The peak flow significantly decreased following both procedures (see Table 3),but the decrease was significantly greater in the TVT group:median difference (IQR),8.6ml/s (8–37)versus 4.9ml/s (2.5–41)in the TVT and TVT-O groups,respectively (p =0.02).Six patients in the TVT-O group and eight patients in the TVT group (p =0.77),who had pre-operatively exhibited a normal flow curve (“bell ”curve as a normal pattern),presented with a de novo altered flow curve (flat or polyphasic)at 12months follow-up.Table 2Objective and subjective cure ratesNo referred leakage at interview subjective cure rate Negative stress test objective cure rate No referred leakage and negative stress test overall cure rate No use of protection other subjective cure rate M6M12M24M6M12M24M6M12M24M6M12M24TVT-O n (%)66/71(93%)61/69(88%)56/67(83%)68/71(96%)67/69(97%)65/67(97%)65/71(91%)61/69(88%)56/67(83%)63/71(88%)58/69(84%)57/67(85%)TVT n (%)63/72(88%)63/69(91%)55/65(84%)69/72(96%)65/69(94%)61/65(94%)63/72(88%)62/69(89%)54/65(83%)62/72(86%)57/69(82%)54/65(83%)p(Fisher test)0.390.77110.680.430.58110.8010.81Abbreviations:M66months follow-up,M1212-months follow-up,M2424months follow-up,TVT tension-free vaginal tape,TVT -O inside-out transobturator mid-urethral sling techniqueTVT-O TVT pn7475Age,years [mean(±SD)]52.8(±9.8)54.6(±10.9)0.30BMI,kg/m 2[mean(±SD)]26.3(±5.7)26.3(±4.5)0.94Parity [mean(±SD)] 2.4(±1.3) 2.4(±1.2)0.91Postmenopausal [n (%)]40(54%)43(57%)0.69Isolated SUI [n (%)]54(73%)49(65%)0.31MUCP,cmH 20[mean(±SD)]52.1(±23.7)53.0(±24.4)0.82MUCP<30cmH2O [n (%)]8(11%)9(12%)0.82Stage I cystocèle24(32%)24(32%)0.90Chronic pelvic pain V AS>30%6(8%)6(8%)0.98Table 1Patient demographicsAbbreviations:MUCP maxi-mum urethral closure pressure,n number,SD standard deviation,VA visual analog scale (0–100)The first voiding desire and maximum urethral closure pressure remained unchanged at the12months urodynamic follow-up in both groups.Quality of life and sexuality findingsWith regard to the sexuality findings of the study,there was a significant increase in sexual activity satisfaction,from the pre-operative to the24-month follow-up evaluation,using the V AS with the TVT-O group[median(IQR)satisfaction,70(50–80) pre-operatively versus90(70–100)at24months follow-up (p=0.0004)]and with the TVT group[median(IQR) satisfaction,70(50–80)pre-operatively versus85(70–100) at24months follow-up(p=0.0009)].This increase in sexual activity satisfaction was associated with a sharp decrease in the incidence of urinary leakage during sexual intercourse: from16/60(26%)pre-operatively to1/52(3%)at24months follow-up in the TVT-O group(p=0.0001)and from11/52 (21%)pre-operatively to0/44(0%)at24months follow-up in the TVT group(p=0.0007).There was no difference between the TVT and TVT-O groups at24months follow-up(p=1). At24months follow-up,the median increase in satisfaction was+10/100(IQR:0–32.5)and+17/100(IQR:20–100),in the TVT and TVT-O groups,respectively(p=0.91).There was no difference between the TVT and TVT-O groups concerning the incidence of deep or superficial dyspareunia,pre-,and post-operatively at6,12,and 24months follow-up.Improvements in most items of the CONTILIFE ques-tionnaire,including global quality of life(question no.28 of CONTILIFE questionnaire),were observed in both the TVT and TVT-O groups,with no difference between these two groups.DiscussionThe present study provides interesting comparative data at 2years follow-up.One interesting finding of the present study is the longitudinal follow-up of post-operative pain scores using the V AS.We have shown that mean pain scores are higher in the TVT-O group,for as much as several weeks following surgery,and that higher pain scores(over30/100)are more common in the TVT-O group until12months follow-up.At the time when the present trial was designed,very few studies included systematic per-operative cystoscopy at the time of the transobturator procedure.Thus,the real bladder perforation rate during transobturator procedures was unknown.In the current study,we observed two cases of bladder perforation during the TVT-O procedure.The bladder perforation rate was twice as high in the TVT group,but the difference between the two procedures was not statistically significant.However,since the number of subjects included in our trial did not reach the statistically required number(n=180)because of insufficient enrol-ments in some centers it is impossible to conclude on this point.The high rate of bladder injury observed in the TVT-O group in the current series is probably related to the systematic use of cystoscopy.A single RCT cannot definitively answer all questions about the role of TVT-O placement and TVT,but it may point to areas of study for future evaluations.Patients and surgeons must be aware of the risk of bladder perforation,even with the transobturator procedure.Unfortunately,some RCT still avoid the sys-tematic use of cystoscopy with transobturator procedures.There are already many published randomized controlled trials comparing the TVT and TVT-O procedures,but the reported follow-up durations are usually very short.Four meta-analyses published in2007and2008reported on13 published randomized controlled trials comparing the retropubic and transobturator approaches[7–15].Among theses studies,none reached24months follow-up.More recent studies have been characterized by similar follow-up durations,ranging from12to18months[16–19].All these RCT showed no significant difference in the objective and subjective continence rates between the retropubic and the transobturator approach.Our data confirms that both procedures appear to be equally effective(objectively and subjectively),with an overall cure rate(no referred leakage and negative stress test)reaching83%in both groups atTable3Pre-operative and12months post-operative urodynamic data Pre-operative12months FU p aPeak flow(ml/s)TVT-O22.50(19.75–34.25)21.50(15.00–27.75)0.05 TVT27.00(20.00–36.00)20.00(15.00–24.00)0.00007 p a0.480.15Post-void residual(ml)TVT-O00.00(00.00–10.00)00.00(00.00–10.25)0.27 TVT00.00(00.00–15.00)10.00(00.00–50.00)0.002 p a0.540.03First voiding desire(ml)TVT-O197(115–228)201(151–247)0.10 TVT170(138–250)200(160–243)0.14p a0.810.70MUCP(cmH2O)TVT-O48(33–63)50(3–60)0.57 TVT50(35–65)50(38–65)0.96p a0.570.94a Wilcoxon testData are given as follows:median[interquartile range(IQR)] Abbreviations:12-months FU12-months follow-up,MUCP maxi-mum urethral closure pressure,n number,SD standard deviation24months follow-up and an improvement in global quality of life.More recently,Porena et al.reported a longer follow-up(mean follow-up,31months)for a RCT comparing the TVT(n=73)and outside-in transobturator TOT(n=75)techniques[20].The overall objective cure (dry)rate was71%for TVT and77%for TOT[20].Finally, in a global population of USI women,at median term follow-up of the retropubic and transobturator approaches, both methods appear to be associated with equal efficien-cies.However,this conclusion is probably incorrect for specific populations,such as those concerned by intrinsic sphincteric deficiency and severe USI,where the retropubic approach appears to be associated with higher cure rates than the transobturator approach[17,21].These two recent RCT advocate the choice of the retropubic approach for women presenting with severe USI or USI associated with intrinsic sphincteric deficiency.Furthermore,a meta-analysis of recent studies revealed that the short-term objective cure rate was borderline worse in the trans-obturator group compared with retropubic TVT(OR=0.62; 95%CI0.37–1.00;p=0.05)[22].In the current study,we observed that,post-operatively, the severity of obstructive symptoms(bladder outlet obstruction)did not increase significantly in either group. Higher post-void residual volumes were observed at 12months follow-up in the TVT group,and the peak flow decreased significantly following both procedures,although the decrease was significantly greater in the TVT group. However,post-void residual was less than100ml and did not result in a change in action even though this finding was statistically significant.A meta-analysis of recent studies also revealed post-operative urinary retention was slightly more in women undergoing TVT than those undergoing transobturator approach[22].The relative urinary obstruction which appears following mid-urethral sling placement procedures is probably involved in the anti-incontinence mechanism,and other prospective studies have revealed a decrease in peak flow following TVT and TVT-O procedures[23].Very little data has been published concerning sexual function following mid-urethral sling procedures.Non-randomized studies have shown that anti-incontinence surgery is mainly associated with an improvement in sexual function[24,25].In the current study,we have observed that this improvement in“sexual well-being”is strongly associated with a decrease in the prevalence of urinary leakage during intercourse.Few studies have compared the retropubic and transobturator approaches with regard to post-operative sexual function.Murphy et al.reported no difference between both procedures in a retrospective study [26].Elzevier et al.assessed post-operative sexual com-plaints related to both TVT-O(inside-out)and TOT (outside-in)procedures[27].There was almost no differ-ence in frequency of sexual intercourse,but an improve-ment in continence during intercourse;continence was reported in40%of the patients before and almost80%after the procedure.The appreciation of sexual intercourse was improved in20%of the patients and diminished in10%of the patients[27].Post-operatively,no difference was observed between the two procedures.Pain resulting from vaginal narrowing was observed significantly more frequently in the TOT procedure group. However,the sling that was used(ObTape,Mentor Corporation,Santa Barbara,CA)was associated with increased rates of inflammation and vaginal extrusion. Thus,these results should not be generalized to the case of the macroporous monofilament slings used at the present time.In the current study(in which the same material,a macroporous monofilament sling,was used for both approaches),the mid-urethral sling procedure is mainly associated with an increase in sexual function outcome, with no significant difference between the TVT and TVT-O procedures.It has been shown that sexual partners rarely report pain or narrowing during intercourse following mid-urethral sling surgery[25,26,28].Mid-urethral sling procedures may decrease the sexual function of some patients,but this is rare(the incidence of de novo dyspareunia was approximately5%at2years follow-up in our series).Patients must be made aware of this point pre-operatively,since it may constitute the basis for post-operative dissatisfaction.Concerning higher pain scores in TVT-O group that we observed in the current series,Wang et al.recently reported a higher rate of groin/thigh pain following TVT-O,when compared with TVT[29].Barber et al.recently published a RCT with a mean follow-up at18months for168women [19].They reported no increase in post-operative pain score in their transobturator group,but the technique used (outside–inside)was different to that reported here for TVT-O.The difference between out-in and in-out proce-dures for the transobturator approach was first reported by Latthe et al.,in a meta-analysis in2007[11].They observed that the increase in post-operative pain was observed only when the retropubic procedure was compared with the inside-out transobturator approach,but not when the retropubic procedure was compared with the outside-in transobturator procedure[11].This outcome is probably related to the anatomical path followed by the device during the surgical procedure,which may be closer to the obturator nerves in the case of the inside-out transobturator proce-dure,when compared with the outside-in transobturator procedure.Obturator nerve neuropathies following the insertion of a transobturator tape are thought to be caused by nerve trauma,although it is unclear whether these are induced by surgical accidents or whether they result from injuries inherent to the tape insertion procedure.Indeed,Corona et al.reported two cases of obturator nerve neuropathy,which occurred following a tension-free vaginal tape procedure,with no direct trauma to the obturator nerve[30].Finally,patients and surgeons should be aware of the risk of post-operative pain.Further studies should assess the impact of post-operative pain on quality of life in groups such as sportive women.ConclusionAnti-incontinence surgery is associated with an increase in outcome of quality of life and sexual function.No significant differences have been observed between the TVT and TVT-O procedures in relation to success, satisfaction rates,and complications at2years follow-up. Acknowledgments Thanks are expressed to all investigators who contributed to this study,including Kristel Desseaux(DBIM,Paris), Bruno Deval(Paris),Delphine Salet-Lizee(Paris),Philippe Descamps (Angers),Claude Hocke(Bordeaux),Brigitte Fatton(Clermont Ferrand),Renaud de Tayrac(Nîmes),Fabrice Sergent(Rouen),Pierre Luc Giacalone(Montpellier),and Jean Leveque(Rennes).Conflicts of interest None.References1.Nilsson CG,Palva K,Rezapour M,Falconer C(2008)Elevenyears prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence.Int Urogynecol J Pelvic Floor Dysfunct19:1043–10472.Delorme E,Droupy S,de Tayrac R,Delmas V(2004)Trans-obturator tape(Uratape):a new minimally invasive procedure to treat female urinary incontinence.Eur Urol45:203–2073.de Leval J(2003)Novel surgical technique for the treatment offemale stress urinary incontinence:transobturator vaginal tape inside-out.Eur Urol44:724–7304.Deffieux X,Donnadieu AC,Mordefroid M,Levante 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