Serious complications and recurrences after pelvic organ prolapse surgery for 2309 women in the VIGI-MESH registry.

OBJECTIVE: To assess the incidence of serious complications and reoperations for recurrence after surgery for pelvic organ prolapse (POP) and compare the three most common types of repair. DESIGN: Prospective cohort study using a registry. SETTING: Nineteen French surgical centres. POPULATION: A total of 2309 women participated between 2017 and 2019. METHODS: A multivariate analysis including an inverse probability of treatment weighting approach was used to obtain three comparable groups. MAIN OUTCOME MEASURES: Serious complications and subsequent reoperations for POP recurrence. RESULTS: The median follow-up time was 17.6 months. Surgeries were native tissue vaginal repairs (n = 504), transvaginal mesh placements (n = 692) and laparoscopic sacropexies with mesh (n = 1113). Serious complications occurred among 52 women (2.3%), and reoperation for POP recurrence was required for 32 women (1.4%). At 1 year the cumulative weighted incidence of serious complications was 1.8% for native tissue vaginal repair, 3.9% for transvaginal mesh and 2.2% for sacropexy, and the rates for reoperation for recurrence of POP were 1.5, 0.7 and 1.1%, respectively. Compared with native tissue vaginal repair, the risk of serious complications was higher in the transvaginal mesh group (weighted hazard ratio, wHR 3.84, 95% CI 2.43-6.08) and the sacropexy group (wHR 2.48, 95% CI 1.45-4.23), whereas the risk of reoperation for prolapse recurrence was lower in both the transvaginal mesh (wHR 0.22, 95% CI 0.13-0.39) and sacropexy (wHR 0.29, 95% CI 0.18-0.47) groups. CONCLUSIONS: Our results suggest that native tissue vaginal repairs have the lowest risk of serious complications but the highest risk of reoperation for recurrence. These results are useful for informing women and for shared decision making. TWEETABLE ABSTRACT: Laparoscopic sacropexy had fewer serious complications than transvaginal mesh and fewer reoperations for recurrence than vaginal repair.

Long-term outcomes of primary cystocele repair by transvaginal mesh surgery versus laparoscopic mesh sacropexy: extended follow up of the PROSPERE multicentre randomised trial.

OBJECTIVE: To compare the effectiveness and safety of laparoscopic sacropexy (LS) and transvaginal mesh (TVM) at 4 years. DESIGN: Extended follow up of a randomised trial. SETTING: Eleven centres. POPULATION: Women with cystocele stage ≥2 (pelvic organ prolapse quantification [POP-Q], aged 45-75 years without previous prolapse surgery. METHODS: Synthetic non-absorbable mesh placed in the vesicovaginal space and sutured to the promontory (LS) or maintained by arms through pelvic ligaments and/or muscles (TVM). MAIN OUTCOME MEASURES: Functional outcomes (pelvic floor distress inventory [PFDI-20] as primary outcome); anatomical assessment (POP-Q), composite outcome of success; re-interventions for complications. RESULTS: A total of 220 out of 262 randomised patients have been followed at 4 years. PFDI-20 significantly improved in both groups and was better (but below the minimal clinically important difference) after LS (mean difference -7.2 points; 95% CI -14.0 to -0.05; P = 0.029). The improvement in quality of life and the success rate (LS 70%, 61-81% versus TVM 71%, 62-81%; hazard ratio 0.92, 95% CI 0.55-1.54; P = 0.75) were similar. POP-Q measurements did not differ, except for point C (LS -57 mm versus TVM -48 mm, P = 0.0093). The grade III or higher complication rate was lower after LS (2%, 0-4.7%) than after TVM (8.7%, 3.4-13.7%; hazard ratio 4.6, 95% CI 1.007-21.0, P = 0.049)). CONCLUSIONS: Both techniques provided improvement and similar success rates. LS had a better benefit-harm balance with fewer re-interventions due to complications. TVM remains an option when LS is not feasible. TWEETABLE ABSTRACT: At 4 years, Laparoscopic Sacropexy (LS) had a better benefit-harm balance with fewer re-interventions due to complications than Trans-Vaginal Mesh (TVM).

Complications after pelvic floor repair surgery (with and without mesh): short-term incidence after 1873 inclusions in the French VIGI-MESH registry.

OBJECTIVE: To assess the short-term incidence of serious complications of surgery for urinary incontinence or pelvic organ prolapse. DESIGN: Prospective longitudinal cohort study using a surgical registry. SETTING: Thirteen public hospitals in France. POPULATION: A cohort of 1873 women undergoing surgery between February 2017 and August 2018. METHODS: Preliminary analysis of serious complications after a mean follow-up of 7 months (0-18 months), according to type of surgery. Surgeons reported procedures and complications, which were verified by the hospitals' information systems. MAIN OUTCOME MEASURES: Serious complication requiring discontinuation of the procedure or subsequent surgical intervention, life-threatening complication requiring resuscitation, or death. RESULTS: Fifty-two women (2.8%, 95% CI 2.1-3.6%) experienced a serious complication either during surgery, requiring the discontinuation of the procedure, or during the first months of follow-up, necessitating a subsequent reoperation. One woman also required resuscitation; no women died. Of 811 midurethral slings (MUSs), 11 were removed in part or totally (1.4%, 0.7-2.3%), as were two of 391 transvaginal meshes (0.5%, 0.1-1.6%), and four of 611 laparoscopically placed mesh implants (0.7%, 0.2-1.5%). The incidence of serious complications 6 months after the surgical procedure was estimated to be around 3.5% (2.0-5.0%) after MUS alone, 7.0% (2.8-11.3%) after MUS with prolapse surgery, 1.7% (0.0-3.8%) after vaginal native tissue repair, 2.8% (0.9-4.6%) after transvaginal mesh, and 1.0% (0.1-1.9%) after laparoscopy with mesh. CONCLUSIONS: Early serious complications are relatively rare. Monitoring must be continued and expanded to assess the long-term risk associated with mesh use and to identify its risk factors. TWEETABLE ABSTRACT: Short-term serious complications are rare after surgery for urinary incontinence or pelvic organ prolapse, even with mesh.

[Ajust(®): prospective study and 1-year follow-up - a series of 60 female patients]. / Ajust(®) : étude prospective et suivi à un an d'une série de 60 patientes.

OBJECTIVES: Evaluate functional and anatomical outcomes as well as complications, 1year after the implantation of the Ajust(®) sub-urethral adjustable single-incision sling. STUDY DESIGN: Prospective study on 60 female patients suffering from stress urinary or mixed urinary incontinence with quality of life assessment. Ambulatory surgeries were performed under local anesthesia with or without sedation. Pain was evaluated using the VAS scale. Postoperative follow-up was performed at 2 and 12months. RESULTS: Forty-eight patients suffered from stress incontinence only, with one of them suffering from sphincter deficiency, and the remaining 12 suffered from mixed urinary incontinence. Mean surgery time was 7.15minutes. All patients received a local anesthesia, and 33 were sedated. Per-operative pain level was equal to 31.8/100, and 17/100 upon discharge. A 100mL per-operative hemorrhage was described. At 2-month follow-up, four de novo urgency, four de novo dysuria, one urinary infection, 11 palpable lateral cords, 12 moderate postoperative pain were described. At 1-year follow-up, two mesh exposures formed, including one expelled anchor for one of them. At 1year, cure rate, improvement and failure rate were respectively 89.6%, 6.9% and 3.4%. Quality of life indexes were significantly improved. One patient required a new surgery at 2months, due to initial failure. CONCLUSIONS: The efficacy of this mini-invasive sling, without specific complication, must be compared with the other classic sub-uretral slings.

[Place of the mini-sling in the treatment of female stress urinary incontinence]. / Place des mini-bandelettes dans le traitement de l'incontinence urinaire de la femme.

OBJECTIVE: Evaluate the place of sub-urethral mini-slings in the treatment of female stress urinary incontinence. MATERIAL AND METHODS: Review of the literature on 43 publications (comparative and prospective studies) more than 6443 patients who underwent for the treatment of urinary incontinence, a mini-strip type TVT®, TVT-S®, MiniArc®, Ajust®, Needleless®, Solyx®, or Ophira® in comparison to the conventional urethral sling. The comparison used objective (cough stress test and pad weight test) and subjective criteria (quality of life questionnaire). The papers have also studied the complication associated with these new techniques. RESULTS: The overall effectiveness of this surgery varied between 40 to 84% for TVT-S®, 69 to 92% for MiniArc®, 80 to 91% for Ajust®, 87% for Needleless®, 95% for Solyx® and 85% for Ophira®. The efficacy on incontinence was higher with the TVT® TVT-S® and the MiniArc® (P=0.01 to 0.05). TVT-O® efficacy was higher than TVT-S® (P<0.01 and P=0.02). Conventional slings seems to be more efficient than TVT-S® and MiniArc® mini-slings. Ajust® mini-sling seems to be as efficient as MiniArc® and TVT-S® mini-sling and TVT-O®. It showed a decrease in the intensity of postoperative pain (P<0.001), faster return to normal activities (P=0.025) and use of a common local anesthetic to the adjustable mini-sling. CONCLUSION: It seems that the adjustable mini-sling is currently the best compromise in terms of effectiveness and complications if the choice had to be among the mini-sling in the treatment of stress urinary incontinence.

[PROSPERE randomized controlled trial: laparoscopic sacropexy versus vaginal mesh for cystocele POP repair]. / Étude randomisée comparant la promontofixation cœlioscopique à la chirurgie prothétique par voie vaginale pour le traitement des cystocèles : PROSPERE (PROSthetic PElvic organ prolapse REpair).

BACKGROUND: Cystocele is a frequent and invalidating type of genital prolapse in woman. Sacropexy using synthetic mesh is considered the surgical gold standard, and the laparoscopic approach has supplanted the open abdominal route because it offers the same anatomical results with a lower morbidity. The use of mesh through the vaginal route may have many advantages: easiness to perform, shorter operative time and recovery, but may increase morbidity. In France, both laparoscopic sacropexy and vaginal mesh are commonly used to treat cystoceles. The French Haute Autorité de santé (HAS) has highlighted the lack of evaluation of safety assessment for vaginal meshes. METHOD/DESIGN: The main objective of the study is to compare the morbidity of laparoscopic sacropexy with vaginal mesh for cystocele repair. The primary endpoint will be the rate of surgical complications greater or equal to grade 2 of the Clavien-Dindo classification at 1-year follow-up. The secondary aims are to compare the functional results in the medium term (sexuality, urinary and bowel symptoms, pain), the impact on quality of life as well as anatomical results. PROSPERE is a randomized controlled trial conducted in 12 participating French hospitals. 262 patients, aged 45 to 75years old, with cystocele greater or equal to stage 2 of the POP-Q classification (isolated or not) will be included. Exclusion criterias are a previous surgical POP repair, and inability or contra-indication to one or the other technique. We have designed this study to answer the question of the choice between laparoscopic sacropexy and vaginal mesh for the treatment of cystocele. The PROSPERE trial aims to help better determine the indications for one or the other of these techniques, which are currently based on subjective choices or school attitudes. This is the reason why competent authorities have asked for such studies.

Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 5-year prospective follow-up study.

INTRODUCTION AND HYPOTHESIS: To evaluate clinical effectiveness and complication rates at 5 years following the total Trans Vaginal Mesh (TVM) technique to treat pelvic organ prolapse. METHODS: Prospective, observational, multi-centre study in patients with prolapse of stage II or higher. RESULTS: Of the 90 women enrolled in the study, 82 (91%) were available for the 5-year follow-up period. At the 5-year endpoint, success, defined as no surgical prolapse reintervention and leading edge <-1 (International Continence Society [ICS] criteria) or above the level of the hymen, was 79% and 87% respectively. A composite criterion of success defined as: leading edge above the hymen (<0) and no bulge symptoms and no reintervention for prolapse was met by 90%, 88% and 84% at the 1-, 3-, and 5-year endpoints respectively. Quality of life improvement was sustained over the 5 years. Over the 5-year follow-up period, a total of only 4 patients (5%) required re-intervention for prolapse, while a total of 14 patients (16%) experienced mesh exposure for which 8 resections needed to be performed. Seven exposures were still ongoing at the 5-year endpoint, all asymptomatic. Only 33 out of 61 (54%) sexually active patients at baseline remained so at 5 years. De novo dyspareunia was reported by 10%, but no new cases at the 5-year endpoint. One patient reported de novo unprovoked mild pelvic pain at 5 years, 5 reported pains during pelvic examination only. CONCLUSIONS: Five-year results indicated that TVM provided a stable anatomical repair. Improvements in QOL and associated improvements in prolapse-specific symptoms were sustained. Minimal new morbidity emerged between the 1- and 5-year follow-up.

Prolapse repair using the Elevate™ kit: prospective study on 70 patients.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to examine the anatomical and functional results of prolapse repair by a vaginal approach using the Elevate kit. METHODS: This was a prospective study of 70 patients presenting with symptomatic urogenital prolapse. Twenty Elevate Anterior, 16 Posterior, and 34 Anterior and Posterior repair systems were placed. Perioperative and postoperative complications were assessed. The patients were interviewed at 2 months and 1 year post-surgery. RESULTS: Recurrences were recorded in 21 patients (31.3%) at the 1-year follow-up. However, at the 1-year follow-up, there were 14 cases (20.9%) of direct recurrence (two anterior, two posterior, and ten combined anterior and posterior) compared with seven cases (10.4%) of indirect recurrence. Of the 21 failures (stage ≥ 2), 13 were stage 2 with the leading edge above the hymen. None of the patients underwent revision surgery. The exposure rate was 4.5%. The anterior and posterior shrinkage rates were 68.7% and 31.9%, respectively. There were four cases of de novo dyspareunia. Patients reported a significant decrease in the impact of pelvic floor distress on the PFIQ-7 questionnaire, but an improvement on the PFDI-20. There was no improvement in sexual function (PISQ-12). CONCLUSIONS: The Elevate™ kit is associated with satisfactory functional results. However, the anatomical results require ongoing evaluation.

[Sub-urethral sling in the treatment of female urinary incontinence: which? how?]. / Traitement chirurgical de l'incontinence urinaire féminine par bandelette sous-urétrale: laquelle? comment?

Review of the literature that formed the basis for drafting the guideline on the sub-uretral sling in the first-line surgical treatment of female stress urinary incontinence. Medline database query since the introduction of TVT on the questions of various chapters and sub-chapters of the present article. The use of tapes made of polypropylene monofilament exclusively, knitted, is recommended to the exclusion of any other material. Regarding the choice of procedure, the objective cure rate of transobturator and retro-pubic routes cannot be evaluated clearly because of vague evaluation criteria from one study to another. Without adequate clinical trials proving their efficacy and safety, the mini-bands can so far be recommended to treat female stress urinary incontinence. Moderate overweight does not affect the results of laying tape. In patients with severe obesity, surgery to correct obesity is even better than surgery for incontinence. Age is not a contra-indication. If the patient is young and nulliparous, it is reasonable to advise her to postpone surgery after her last pregnancy. In case of multiparous patient, the risk of vaginal delivery does not seem sufficient to suggest a cesarean section. To conclude, sub-urethral slings are the first-line surgical treatment of female stress urinary incontinence.

[Guidelines for the surgical treatment of female urinary stress incontinence in women using the suburethral sling]. / Recommandations pour le traitement chirurgical de l'incontinence urinaire d'effort de la femme par bandelettes sous-urétrales.

Today, placement of a suburethral sling is the reference technique for cure of female stress incontinence. Use of slings made exclusively of knitted polypropylene monofilament is recommended to the exclusion of all other materials. The NF indication is a guarantee that preclinical studies have been conducted before market authorization. Although biocompatible, the material remains synthetic, and this biocompatibility should not obviate the need for respecting the principles of asepsis, as in any prosthesis implantation. The sling can be placed via a retropubic or transobturator approach. These two approaches enjoy the same success rate but morbidity seems to be higher with the retropubic approach (bladder injury, dysuria, de novo urge incontinence). The type of anesthesia has no influence on the postoperative results. Mixed urinary incontinence, low urethral mobility, obesity, old age, and the desire for future pregnancies are situations that do not contraindicate placement of suburethral slings, but they can alter the quality of the results. Rigorous assessment of the risks and benefits as well as fair and honest information must be provided to patients in these situations. Without sufficient studies proving their efficacy and innocuousness, minislings cannot today be recommended to treat female urinary stress incontinence.

[Synthesis of the guidelines for the treatment of non-neurological urinary incontinence in women]. / Synthèse des recommandations pour le traitement de l'incontinence urinaire féminine non neurologique.

The last two decades have brought about new medical and surgical treatments revolutionizing care for non-neurological urinary incontinence in women. Many studies, often randomized prospective studies with sufficient follow-up, have validated the therapeutic choices and shown them not to be part of a fad or marketing pressures. The French Association of Urology (L'Association Française d'Urologie), through its Committee on Women's Urology and Pelviperineology (Comité d'Urologie et de Pelvipérinéologie de la Femme), proposes its recommendations. These were established by an expert group of specialists (urologists, gynecologists, and physical therapists), based on a review of the literature but taking into account the daily practices in academic and private practice settings. Between evidence-based medicine and reality in the field, these recommendations attempt to propose realistic and applicable strategies.

[Miniarc : prospective study and follow up at one year about 72 patients]. / MiniArc : étude prospective et suivi à un an d'une série de 72 patientes.

OBJECTIVE: To evaluate the results at 1 year of a mini invasive sub urethral sling, not requiring no more a single incision. PATIENTS AND METHODS: Prospective study of 72 patients with isolated stress urinary incontinence. The procedures were performed on an outpatient under local anesthesia. Pain was assessed using the visual analogue scale. All patients were checked at 2 months and 1 year of intervention. RESULTS: Stress urinary incontinence for 58 patients, 14 for mixed incontinence and sphincter deficiency for five. As per procedure, the average pain was 3.7/10, at the end of the intervention, 0.5/10. Peroperative complications were: one episode involving bleeding over 100ml, one vasovagal episode, and one procedure failure. At 2 months follow-up, the authors recorded: de novo urge incontinence (n=2), de novo dysuria (n=1), sling exposure (n=1), urinary infection (n=1) and noticeable side ties (n=4). Control at 1 year, another patient filed an eviction of the anchor of the tape with Stall thereof. Two patients reported having moderate pain. The objective results at 1 year of 68 patients were 69.1% cured, 20.6% improved and 10.3% failed. Three patients were re-operated and two of them are cured. CONCLUSION: The results of this simplified tape are worse than those of classic sub-urethral tape; however, no comparative study has been completed and the specific indications of these techniques are not specified.

[Should a hysterectomy be carried at the same time as surgery for a prolapse by vaginal route?]. / Faut-il faire une hystérectomie au cours de la chirurgie du prolapsus par voie vaginale?

Classically hysterectomy is done during vaginal surgery for prolapse. But the anatomical and physiopathological facts would be in favour of uterus or cervix preservation. Uterine preservation do not modify the anatomical results of prolapse surgery. If a mesh is used, uterine or cervix preservation reduce the chance for a vaginal erosion. The sexual consequences, aside the narrow vaginal tube, are more psychological than objectively proved. The wish of pregnancy in young patient must leads to conservative procedures with sacrofixation (Richter or Richardson) better than cervix ablation (Manchester procedure). Further uterine or ovarian pathologies are as rare as to justify hysterectomy or annexectomy, the patient must be aware of a regular gynecological exam. Hysterectomy implies more bleeding, more hospital stay, more cost. So hysterectomy during vaginal surgery for prolapse would indicate for major hysterocele or in case of concomitant uterine pathology.

[TVT Secur: prospective study and follow up at 1 year about 154 patients]. / TVT Secur : étude prospective et suivi à un an de 154 patientes.

OBJECTIVES: To evaluate the efficacy and complications of this new sub-urethral tape procedure with a follow up of 12 months. MATERIALS AND METHODS: Prospective, multicenter study of 154 patients operated for stress urinary incontinence with the TVT Secur. Patients were operated between 24 July 2006 and 18 December 2007 and were all controlled at 2 months and 118 at 1 year. No associated surgical procedure was performed. RESULTS: One hundred five patients had pure stress incontinence with 12 of them presenting an intrinsic sphincter deficient. Forty-nine had a mixed urinary incontinence with 12 of them having ISD. Preoperatively, 69 patients complained of urgency and 12 of micturation disorder. Anaesthesia was local for 97 patients (63%). Per operative complications were five hemorrhages, one bladder injury, one vaginal wound, 21 patients had post-void residual volume (100 to 200ml) and one groin pain. We noted two exposed tapes, one granuloma, one ITU and seven lateral vaginal bands. Among the patients with urge at baseline, 61.2% were cured at 2 months and 75.5% at 1 year. De novo urge appeared in 12.8% at 2 months and 12.3% at 1 year. De novo micturation disorder was found in 9.5% at 2 months and 3.7% at 1 year. The cured patients at 1 year were 70.3%, improved 11% and fails 18.7%. The cured rate remains same between 2 months and 1 year. The improved patients (24%) at 2 months remain 11% at 1 year. The recurrence rate was 12,8% at 1 year. CONCLUSION: The results are inferior to TVT or TVT-O procedures. We probably must selected the patients for this procedure.

[MiniArc: preliminary prospective study on 72 cases]. / MiniArc : résultats à court terme d'une série prospective de 72 cas.

OBJECTIVES: To present a new mini-invasive tape requiring only a single incision, to assess the complications and short-term results. MATERIALS AND METHODS: Prospective study of 72 patients with stress urinary incontinence. Were selected for the study patients with stress urinary incontinence with or without intrinsic sphincter deficiency and mixed urinary incontinence with a predominance of leaks to the effort. Patients were evaluated at 2 months of the intervention. RESULTS: Isolated stress urinary incontinence for 58 patients, mixed incontinence for 14 and intrinsic sphincter deficiency for five. The complications per procedure revealed one bleeding over 100ml, one malaise vagal and a failure of the procedure. At 2 months, the authors found: two urgenturies de novo, one de novo micturition disorder, one erosion, one urinary tract infection and four lateral vaginal bands. The early objective results are overall 75.7% of dry patients (79.6% for pure SUI, 66.6% for IUE with ISD and 61.5% for mixed incontinence). The overall failure rate was 2.9%. CONCLUSION: The results of this simplified tape are worse than those of TVT and transobturator tapes.

[Female stress urinary incontinence first line surgical treatment]. / Traitement chirurgical de première intention de l'incontinence urinaire d'effort de la femme.

The sub uretral slings (SUS) have supplanted all other techniques in the treatment of stress urinary incontinence in first-line both at ease, results, consequences and cost. However the results are comparable with the abdominal retropubic colposuspension. The elective indication for BSU is stress incontinence. In the mixed incontinence, the results are satisfactory and depend on the degree of urge incontinence. The intrinsic sphincter deficiency with mobile uretra can be used in indications laying BSU. Only a BMI ≥ 35 is a pejorative factor on the outcome of the SUS. Currently, all routes retro pubic or obturator may be used without one being superior to another. For lack of comparative studies, using mini strips is currently under reserve. No recommendation can be given regarding the installation of urinary catheter in per and post operative. The relevance of cystoscopy for all routes used with the SUS is not formal. The SUS can be raised as an outpatient, but the patient must choose. It is the same type of anesthesia that is free and does not affect the results. The peri-urethral injections have no place as first choice because they offer a lower success rate. The SUS should be knitted polypropylene monofilament. Users should require the manufacturer that implants meet the AFNOR standard.

[TVT Secur: more and more minimally invasive. Preliminary prospective study of 110 cases]. / TVT Secur: de plus en plus minimal invasif. Etude préliminaire prospective sur 110 cas.

OBJECTIVES: To present a new minimal invasive suburethral tape device derivative of the classic TVT, to describe the technique of laying, to evaluate complications and results to short term. MATERIALS AND METHODS: Prospective multicentric study of 110 patients presenting a stress urinary incontinence and benefiting from the laying of TVT Secur without associated operation. The tape is identical to that old-fashioned retropubic and obturator TVT, smaller, laying in "U" or in "hammock" without orifice of exit, to avoid complications due to crossed spaces of the other techniques. The device and the technique of laying are described by authors. The originality of the TVT Secur resides in the mechanism of insertion of the tape to a metallic divice. All patients have been controlled at two months and complications with notably pains (quotation VAS) as well as objective results have been reported. RESULTS: Pure and isolated stress urinary incontinence for 71 patients, mixed incontinence for 39 and sphincter deficient for 23. Preoperative urgency for 49 patients and dysuria for 10 of them. The method "hammock" has been used in 85.5% of cases. The type of anaesthesia has been pure local for 69.1% (0 to 98.8% for the different centers) with an average operative time of 8'30". Under local anaesthesia, the average per operative pain was quoted 2.8/10, and 0.7 at the end of intervention. Peroperative complications have revealed a wound of bladder, a vaginal wound and four bleeding of more than 100ml. In immediate continuations a total retention yielding to 24h and 13 postmicturition residual between 100 and 200ml have been mentioned. At two months, authors have observed the following: de novo urgency in 19.6%, de novo dysuria in 13.2%, one tape exposition, one granuloma, one urinary infection and seven perceptible lateral cords without pain. Thirteen patients have signalled to have had moderated pains on a duration of four to 30 days. Early objective results are globally 70.4% of dry patients (83% for pure isolated SUI, 72.2% for SUI with deficient sphincter, 50% for mixed incontinence). The pure local anaesthesia was recommended by 98% of patients. CONCLUSION: The diminution of complications ahead not to be made to the detriment of results, it is necessary to envisage multicentric studies with standardized modifications. The indications of this new device will have to be defined.