Serious complications and recurrences after retropubic vs transobturator midurethral sling procedures for 2682 patients in the VIGI-MESH register.

BACKGROUND: Midurethral slings are the gold standard for treating stress urinary incontinence, but their complications may raise concerns. Complications may differ by the approach used to place them. OBJECTIVE: This study aimed to compare serious complications and reoperations for recurrence after midurethral sling procedures when using the retropubic vs the transobturator route for female stress urinary incontinence. STUDY DESIGN: This analysis was of patients included in the French, multicenter VIGI-MESH register since February 2017 who received a midurethral sling for female stress urinary incontinence either by the retropubic or the transobturator route and excluded patients with single-incision slings. Follow-up continued until October 2021. Serious complications (Clavien-Dindo classification ≥ grade III) attributable to the midurethral sling and reoperations for recurrence were compared using Cox proportional hazard models including any associated surgery (hysterectomy or prolapse) and a frailty term to consider the center effect. Baseline differences were balanced by propensity score weighting. Analyses using the propensity score and Cox models were adjusted for baseline differences, center effect, and associated surgery. RESULTS: A total of 1830 participants received a retropubic sling and 852 received a transobturator sling in 27 French centers that were placed by 167 surgeons. The cumulative 2-year estimate of serious complications was 5.8% (95% confidence interval, 4.8-7.0) in the retropubic group and 2.9% (95% confidence interval, 1.9-4.3) in the transobturator group, that is, after adjustment, half of the retropubic group was affected (adjusted hazard ratio, 0.41; 95% confidence interval, 0.3-0.6). The cumulative 2-year estimate of reoperation for recurrence of stress urinary incontinence was 2.7% (95% confidence interval, 2.0-3.6) in the retropubic group and 2.8% (95% confidence interval, 1.7-4.2) in the transobturator group with risk for revision for recurrence being higher in the transobturator group after adjustment (adjusted hazard ratio, 1.9; 95% confidence interval, 1.2-2.9); this surplus risk disappeared after exclusion of the patients with a previous surgery for stress urinary incontinence. CONCLUSION: The transobturator route for midurethral sling placement is associated with a lower risk for serious complications but a higher risk for surgical reoperation for recurrence than the retropubic route. Despite the large number of surgeons involved, these risks were low. The data are therefore reassuring.

Do Surgeons Anticipate Women's Hopes and Fears Associated with Prolapse Repair? A Qualitative Analysis in the PROSPERE Trial.

Women's preoperative perceptions of pelvic-floor disorders may differ from those of their physicians. Our objective was to specify women's hopes and fears before cystocele repair, and to compare them to those that surgeons anticipate. We performed a secondary qualitative analysis of data from the PROSPERE trial. Among the 265 women included, 98% reported at least one hope and 86% one fear before surgery. Sixteen surgeons also completed the free expectations-questionnaire as a typical patient would. Women's hopes covered seven themes, and women's fears eleven. Women's hopes were concerning prolapse repair (60%), improvement of urinary function (39%), capacity for physical activities (28%), sexual function (27%), well-being (25%), and end of pain or heaviness (19%). Women's fears were concerning prolapse relapse (38%), perioperative concerns (28%), urinary disorders (26%), pain (19%), sexual problems (10%), and physical impairment (6%). Surgeons anticipated typical hopes and fears which were very similar to those the majority of women reported. However, only 60% of the women reported prolapse repair as an expectation. Women's expectations appear reasonable and consistent with the scientific literature on the improvement and the risk of relapse or complication related to cystocele repair. Our analysis encourages surgeons to consider individual woman's expectations before pelvic-floor repair.

Serious Complications and Recurrence following Sacrospinous Ligament Fixation for the Correction of Apical Prolapse.

Objective: To evaluate the rates of serious complications and reoperation for recurrence following sacrospinous ligament fixation (SSLF) for apical pelvic organ prolapse. Methods: This was a national registry ancillary cohort comparative study. The VIGI-MESH registry includes data from 24 French health centers prospectively collected between May 2017 and September 2021. Time to occurrence of a serious complication or reoperation for genital prolapse recurrence was explored using the Kaplan-Meier curve and Log-rank test. The inverse probability of treatment weighting, based on propensity scores, was used to adjust for between-group differences. Results: A total of 1359 women were included and four surgical groups were analyzed: Anterior SSLF with mesh (n = 566), Anterior SSLF with native tissue (n = 331), Posterior SSLF with mesh (n = 57), and Posterior SSLF with native tissue (n = 405). Clavien-Dindo Grade III complications or higher were reported in 34 (2.5%) cases, with no statistically significant differences between the groups. Pelvic organ prolapse recurrence requiring re-operation was reported in 44 (3.2%) women, this was higher following posterior compared with anterior SSLF (p = 0.0034). Conclusions: According to this large database ancillary study, sacrospinous ligament fixation is an effective and safe surgical treatment for apical prolapse. The different surgical approaches (anterior/posterior and with/without mesh) have comparable safety profiles. However, the anterior approach and the use of mesh were associated with a lower risk of reoperation for recurrence compared with the posterior approach and the use of native tissue, respectively.

French validation of the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-IUGA revised (PISQ-IR).

INTRODUCTION AND HYPOTHESIS: The aim of this study was to clinically validate the French-translated PISQ-IR in a French-speaking population of women with pelvic floor disorders. METHODS: We aimed to recruit 300 women to account for potential attrition secondary to failure to respond or loss to follow-up. Women were enrolled as part of an RCT and from a separate specific study. Both studies included surgically managed patients. Data were collected at recruitment, visit 1 (V1), V2 (9-12 months postoperatively) and V3 (V2 + 5-15 days). Participants also completed a PFDI 20, ICI-Q and FSFI and were assessed by POP-Q. RESULTS: A total of 297 women were recruited between 18 January 2013 and 18 January 2016. Data were available for 291, 148 and 110 participants at V1, V2 and V3, respectively. The non-response rate for the NSA items varied from 5% to 30%, while for SA women, the non-response rate for the items varied from 0% to 15%. The tool was deemed reliable for five domains of the summary score. We also identified that several sections demonstrated acceptable to good temporal stability. A statistically significant score change was identified in different domains in the participants categorized as improved on either PGI-I or POP-Q. We also identified moderate to strong correlations between PISQ-IR and FSFI. CONCLUSIONS: The French translated PISQ-IR has several strengths in support of its validity. Our findings confirm the validity of the summary scores in addition to the item-based initial scoring system.

Clinical evaluation of the Uphold LITE mesh for the surgical treatment of anterior and apical prolapse: A prospective, multicentre trial.

AIMS: To evaluate the safety and efficacy of the Uphold LITE mesh in the treatment of pelvic organ prolapse at 12-month follow-up. METHODS: Women undergoing a mesh surgery due to an anterior prolapse plus a symptomatic anterior prolapse (classed as pelvic organ prolapse quantification stage ≥2) were included in this prospective, multicentre, observational study. The primary endpoint was a composite outcome including a good anatomical correction, no prolapse symptoms, and no reintervention for an anterior or apical recurrent prolapse within 12 months of surgery. Secondary outcomes included safety, improvements in quality of life (QoL), and risk factor for recurrence. This study was registered with ClinicalTrials.gov, number NCT01559168. RESULTS: A total of 121 patients were included. Symptomatic and anatomic cure rates were 94% (95 of 101) and 76.8% (76 of 99), respectively. The composite success rate was 72.4% (71 of 98). The rate of reoperation for apical or anterior recurrent prolapse was 3.9% (4 of 103). Anatomical anterior or apical recurrence occurred in 18.2% (18 of 97) and 7.2% (7 of 97) of patients, respectively. The composite success rate was significantly higher in centres where more than 30 patients had been treated (80% vs 50%; P = .045). The rate of serious complication was 5.4% (6 of 111). Improvements were recorded in QoL including sexual function. CONCLUSIONS: The Uphold LITE mesh procedure provides satisfactory outcomes in the treatment of anterior and apical prolapse, particularly in high-volume centres. The rates of adverse effects and reintervention for recurrent prolapse were acceptable.

Perioperative morbi-mortality after pelvic organ prolapse surgery in a large French national database from gynecologist surgeons.

OBJECTIVE: To assess morbidity and mortality following pelvic organ prolapse surgery in France, irrespective of the surgical technique, using a broad national database. MATERIALS AND METHODS: This descriptive multicenter retrospective study was conducted using a database populated via an application run by a professional association. RESULTS: 286 gynecologists contributed data to the database. Of the 4322 surgeries analyzed, an abdominal approach was used in 975 of cases (22.5%), a vaginal approach in 3277 (75.9%), and a combined approach in 68 (1.6%). After one year, abdominal surgery was associated with higher rates of de novo urinary incontinence, constipation, and intestinal obstruction, whereas vaginal surgery was associated with higher rates of urinary retention, hematoma, de novo chronic pain, and vaginal mesh extrusion. There was no significant difference between the groups in the incidence of severe complications. After one year, vaginal mesh-augmented cystocele repair was associated with higher rates of de novo urinary incontinence, de novo chronic pain, and reoperation than native tissue repair. Mesh repair was also associated with higher rates of severe complications at one year. CONCLUSION: After pelvic organ prolapse surgery, the perioperative morbidity and mortality associated with transabdominal and transvaginal approaches are similar. However, transvaginal mesh repair is associated with greater perioperative morbidity than transvaginal native tissue repair.

Transvaginal treatment of anterior and apical genital prolapses using an Ultra lightweight mesh: Restorelle® Direct Fix™. A retrospective study on feasibility and morbidity.

BACKGROUND: Vaginal mesh safety information is limited, especially concerning single incision techniques using ultra lightweight meshes for the treatment of anterior pelvic organ prolapse (POP). OBJECTIVE: To determine the intraoperative and postoperative complication rates after anterior POP repair involving an ultralight mesh (19g/m2): Restorelle® Direct Fix™. METHODS: A case series of 218 consecutive patients, operated on between January 2013 and December 2016 in ten tertiary and secondary care centres, was retrospectively analyzed. Eligible patients had POP vaginal repair (recurrent or not) planned with anterior Restorelle® Direct Fix™ mesh (with or without posterior mesh). Surgical complications were graded using the Clavien-Dindo classification. RESULTS: Intraoperative complications were bladder wound (0.5%), rectal wound (0.5%), ureteral injuries (0.9%). 98.2% of the patient did not have per operative complications. We observed one fail of procedure. Early complications mainly included urinary retention (8.7%) urinary tract infections (5.5%) and haematoma (2.7%). One haematoma required surgical treatment and another, embolization. 80.7% of the patient did not have complications during hospitalization and 80.3% did not have complication at the follow up visit. None of the analyzed factors (age, body mass index, surgical history, grade of prolapse or concomitant procedure) was significantly associated with the risk of perioperative complications. A total of 2.8% patients had grade III complications according Clavien Dindo. None had grade IV or V. CONCLUSIONS: This multicentre case-series on the early experience of the use of anterior Restorelle® Direct Fix™ mesh showed a satisfactory technical feasibility and a low rate of grade III complications according Clavien Dindo. Long term studies are necessary to assess anterior Restorelle® Direct Fix™ mesh performances and to appraise patient satisfaction feedback.

Safety of Vaginal Mesh Surgery Versus Laparoscopic Mesh Sacropexy for Cystocele Repair: Results of the Prosthetic Pelvic Floor Repair Randomized Controlled Trial.

BACKGROUND: Laparoscopic mesh sacropexy (LS) or transvaginal mesh repair (TVM) are surgical techniques used to treat cystoceles. Health authorities have highlighted the need for comparative studies to evaluate the safety of surgeries with meshes. OBJECTIVE: To compare the rate of complications, and functional and anatomical outcomes between LS and TVM. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized controlled trial from October 2012 to April 2014 in 11 French public hospitals. Women with cystocele stage ≥2 (pelvic organ prolapse quantification), aged 45-75 yr, without previous prolapse surgery. INTERVENTION: Synthetic nonabsorbable mesh placed in the vesicovaginal space, sutured to the promontory (LS) or maintained by arms through pelvic ligaments (TVM). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Rate of surgical complications ≥grade II according to the modified Clavien-Dindo classification at 1 yr. Secondary outcomes were reintervention rate, and functional and anatomical results. RESULTS AND LIMITATIONS: A total of 130 women were randomized in LS and 132 in TVM; five women withdrew before intervention, leaving 129 in LS and 128 in TVM. The rate of complications ≥grade II was lower after LS than after TVM, but did not meet statistical significance (17% vs 26%, treatment difference 8.6% [95% confidence interval, CI -1.5 to 18]; p=0.088). The rate of complications of grade III or higher was nonetheless significantly lower after LS (LS=0.8%, TVM=9.4%, treatment difference 8.6% [95% CI 3.4%; 15%]; p=0.001). LS was converted to TVM in 6.3%. The total reoperation rate was lower after LS but did not meet statistical significance (LS=4.7%, TVM=10.9%, treatment difference 6.3% [95% CI -0.4 to 13.3]; p=0.060). There was no difference in symptoms, quality of life, improvement, composite definition of success, anatomical results rates between groups except for the vaginal apex and length, and dyspareunia (in favor of LS). CONCLUSIONS: LS is a valuable option for primary repair of cystocele in sexually active patients. LS is safer than TVM, but may not be feasible in all cases. Both techniques offer same functional outcomes, success rates, and anatomical outcomes, but sexual function is better preserved by LS. PATIENT SUMMARY: Our study demonstrates that laparoscopic sacropexy (LS) is a valuable option for primary repair of cystocele. LS offers equivalent success rates to vaginal mesh procedures, but is safer with a lower rate of complications and reoperations, and sexual function is better preserved.

Outcomes associated with the use of midurethral slings for stress incontinence surgery according to the type of hospitalization.

OBJECTIVE: To evaluate the influence of type of hospitalization on outcomes of stress urinary incontinence (SUI) surgery using a midurethral sling procedure. METHODS: A retrospective secondary analysis was conducted using data from a prospective multicenter randomized trial of SUI surgery at several sites in France between January 1, 2003, and December 31, 2007. Type of hospitalization was chosen according to the surgeon's policy. RESULTS: Among 149 participants, 31 (20.8%) were treated as outpatients and 118 (79.2%) as inpatients. Perioperative complications were recorded for 1 (3.2%) outpatient and 12 (10.1%) inpatients (P=0.388). At 24months of follow-up, none of 25 outpatients and 6 (5.6%) of 107 inpatients had a positive stress test result (P=0.497). Dryness was reported at this time point by 22 (88.0%) outpatients and 89 (83.2%) inpatients (P=0.922). The median satisfaction score (measured by visual analog scale [scores of 0-100]) at 12months was 100.0 (interquartile range [IQR] 93.5-100.0) among outpatients versus 96.5 (IQR 80.0-100.0; P=0.003) among inpatients. Similar results were observed at 24months (P=0.003). CONCLUSION: Complication and failure rates were similar in both groups, but satisfaction was higher among outpatients.

Vaginal prolapse repair using the Prolift kit: a registry of 100 successive cases.

OBJECTIVES: To evaluate anatomical, functional outcomes and complications inherent to the treatment of pelvic organ prolapse by implantation of polypropylene mesh, using the Prolift kit. MATERIALS AND METHODS: Single-center observational study of 100 successive patients enrolled in a registry, who underwent Prolift prolapse repair. Data on prior treatments, associated procedures and per- and post-operative complications were collected and the patients were seen after 2, 6 and 12 months. Anatomical outcomes were assessed using the International Continence Society Pelvic Organ Prolapse Quantification (ICS POP-Q) system. Function was assessed in terms of urinary and digestive problems, and impact on sex life. Failure was defined as relapse of POP-Q Grade 2 or more. RESULTS: Of the 100 patients, 32 had an anterior, 14 a posterior, 54 a total Prolift; 53 had concomitant urinary incontinence surgery. At 6 and 12 months respectively, 8% and 12% of the patients were lost to follow-up. Mean operating time was 39.8 min. With respect to peri-operative complications, there was no bladder or rectal damage but three patients experienced bleeding (≥ 300 ml) without needing transfusion. POP-Q Grades before surgery were: Grades III-IV cystocele in 65.7% of the anterior Prolift patients; Grades II-III rectocele in the posterior; and 77.8% of total were Grade III and 11.1% Grade IV. The incidence of recurrence was 3.6% at Month 6 and 10.2% at Month 12. Significant (p<0.05) improvements were seen in median scores for the various POP-Q items. With respect to functional problems, stress urinary incontinence was cured in 92% of the patients but 7.7% reported new-onset urinary incontinence after one year. One case of vaginal exposure after one year was observed and major or symptomatic mesh retraction was observed in 8%. New-onset dyspareunia was reported by 11.1% of the patients. CONCLUSIONS: These results confirm the feasibility of using the Prolift kit in the repair of prolapse via a vaginal approach and the low per- and post-operative morbidity associated with that technique. Nevertheless, longer-term evaluation is required to confirm the results.

Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 3-year prospective follow-up study.

INTRODUCTION AND HYPOTHESIS: To evaluate clinical outcomes at 3 years following total transvaginal mesh (TVM) technique to treat vaginal prolapse. METHODS: Prospective, observational study in patients with prolapse ≥ stage II. Success was defined as POP-Q-stage 0-I and absence of surgical re-intervention for prolapse. Secondary outcome measures were: quality of life (QOL), prolapse-specific inventory (PSI), impact on sexual activity and complications. RESULTS: Ninety women underwent TVM repair, 72 a hysterectomy. Anatomical failure rate was 20.0% at 3 years. Three patients required re-intervention for prolapse. Improvements in QOL- and PSI-scores were observed at 1 and 3 years. Vaginal mesh extrusion occurred in 14.4% patients. After 3 years, 4.7% asymptomatic extrusions remained present. Of 61 sexually active women at baseline, a significant number of patients (41%) ceased sexual activity by 3 years; de novo dyspareunia was reported by 8.8%. One vesico-vaginal fistula resolved after surgery. CONCLUSION: Medium-term results demonstrate that the TVM technique provides a durable prolapse repair.

Transobturator TVT-O versus retropubic TVT: results of a multicenter randomized controlled trial at 24 months follow-up.

INTRODUCTION 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, and 2, 6, 12, and 24 months post-operatively. RESULTS: One hundred forty-nine patients underwent surgery, and 132 completed a 24-month follow-up. Bladder injury rate was 5% (4/75) in the TVT group and 2% (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 at 24 months follow-up. The range of mean pain scores was significantly higher after the TVT-O procedure post-operatively but not at 24 months 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 at 2 years follow-up.

Diagnosis and management of adult female stress urinary incontinence: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians.

Urinary incontinence is a frequent affliction in women and may be disabling and costly {LE1}. When consulting for urinary incontinence, it is recommended that circumstances, frequency and severity of leaks be specified {Grade B}. The cough test is recommended prior to surgery {Grade C}. Urodynamic investigations are not needed before lower urinary tract rehabilitation {Grade B}. A complete urodynamic investigation is recommended prior to surgery for urinary incontinence {Grade C}. In cases of pure stress urinary incontinence, urodynamic investigations are not essential prior to surgery provided the clinical assessment is fully comprehensive (standardised questionnaire, cough test, bladder diary, post-void residual volume) with concordant results {PC}. It is recommended to start treatment for stress incontinence with pelvic floor muscle training {Grade C}. Bladder training is recommended at first intention in cases with overactive bladder syndrome {Grade C}. For overweight patients, loss of weight improves stress incontinence {LE1}. For surgery, sub-urethral tape (retropubic or transobturator route) is the first-line recommended technique {Grade B}. Sub-urethral tape surgery involves intraoperative risks, postoperative risks and a risk of failure which must be the subject of prior information {Grade A}. Elective caesarean section and systematic episiotomy are not recommended methods of prevention for urinary incontinence {Grade B}. Pelvic floor muscle training is the treatment of first intention for pre- and postnatal urinary incontinence {Grade A}. Prior to any treatment for an elderly woman, it is recommended to screen for urinary infection using a test strip, ask for a bladder diary and measure post-void residual volume {Grade C}. It is recommended to carry out a cough test and look for occult incontinence prior to surgery for pelvic organ prolapse {Grade C}. It is recommended to carry out urodynamic investigations prior to pelvic organ prolapse surgery when there are urinary symptoms or occult urinary incontinence {Grade C}.

Safety of Trans Vaginal Mesh procedure: retrospective study of 684 patients.

AIM: To study peri-surgical complications after cure of genital prolapse by vaginal route using interposition of synthetic prostheses Gynemesh Prolene Soft (Gynecare) following the Trans Vaginal Mesh (TVM) technique. METHODS: The present retrospective multicentered study comprised 684 patients who underwent surgery at seven French centers between October 2002 and December 2004. All patients had a genital prolapse >or=3 (C3/H3/E3/R3) according to International continence society (ICS) classification. According to each case, prosthetic interposition was total, or anterior only or posterior only. Patients were systematically seen 6 weeks, 3 months and 6 months after surgery. Multivaried statistical analysis followed a model of logistic regression applied to each post-surgical complication. RESULTS: The mean age of patients was 63.5 years (30-94). The mean follow-up period was 3.6 months. 84.3% of patients were post-menopause, 24.3% had hysterectomy, 16.7% previous cure of prolapse, and 11.1% cure of stress urinary incontinence (SUI). During the procedure, hysterectomy was combined in 50.3% of cases, cervix amputation in 1.5%, and cure of SUI in 40.9%. 15.8% were treated for a cystocele only. 14.8% had only a rectocele +/- elytrocele and 69.4% had a prolapse touching both compartments, anterior and posterior. In peri-surgical complications, (2%) were five bladder wounds (0.7%), one rectal wound (0.15%) and seven hemorrhages greater that 200 mL (1%). Among early post-surgical complications (during the first month after surgery) (2.8%) were two pelvic abscesses (0.29%), 13 pelvic hematomas (1.9%), one pelvic cellulitis (0.15%), two vesicovaginal fistulas and one rectovaginal fistula (0.15%). Among late post-surgical complications (33.6%) there were 77 granulomas or prosthetic expositions (11.3% [6.7% in the vaginal anterior wall, 2.1% in the vaginal posterior wall and 4.8% in the fornix]), 80 prosthetic retractions (11.7%), 36 relapse of prolapse (6.9%) and 37 SUI de novo (5.4%). Multivaried analysis shows that previous history of hysterectomy or placing of an isolated anterior prosthesis increase the risk of peri-surgical complication; preserved uterus and isolated posterior prosthesis lessen the risk of granulomas and prosthetic retractions; and association of a Richter's intervention increases the rate of prosthetic retractions. CONCLUSION: Cure of genital prolapse with synthetic prostheses interposed by vaginal route is now reliable and can be reproduced with a low rate of peri- and early post-surgical complications. However, our study shows a certain number of late post-surgical complications after insertion of strengthening synthetic vaginal implants (prosthetic expositions and prosthetic retractions). These retrospective results will soon be compared to a prospective study.

Trans-obturator urethral sling for the surgical correction of female stress urinary incontinence: outside-in (Monarc) versus inside-out (TVT-O). Are the two ways reassuring?

INTRODUCTION: In 2001, the trans-obturator route was proposed for the surgical positioning of tape with a view to avoiding the retropubic space and its disadvantages. The route, originally described outside-in by Delorme was presented inside-out by de Leval. Since then, anatomical discussions have attempted to prove that one technique is safer than the other. OBJECTIVE: Demonstrating the safety of the two techniques through personal and published experience. MATERIAL AND METHODS: Non-randomized, prospective, observational, open-label, longitudinal study of 100 female patients (50 tension-free vaginal tape (TVT)-O and 50 Monarc). All the female patients presented with isolated stress urinary incontinence. Only four patients presented with mixed incontinence in the Monarc (MON) group. Sphincter incompetence was observed four times in the MON group and three times in the TVT-O group. Almost all the patients were undergoing their first procedure. All the patients underwent surgery under assisted local anesthesia in a day-hospital setting. All the patients underwent a full gynecological examination and a urodynamic assessment. Only those patients presenting with patent established urinary incontinence, corrected by the TVT test, underwent surgery. Post-operative control was conducted at 3 months and 1 year when a physical examination and urodynamic assessment were implemented. RESULTS: All the patients underwent control up to time point 12 months. The duration of hospitalization was 10h for 48 patients in the MON group and 49 in the TVT-O group. The duration of hospitalization was 24h for one patient in each group and 4 days for one patient in the TVT-O group due to transient urine retention. The only per-operative complication was a vaginal perforation in the lateral angle of the vagina for a MON patient. Tape repositioning was necessary. Early post-operative complications were observed in the MON group: three cases of urinary tract infection, one of transient urine retention, three of pain in the thighs spontaneously resolving within 4 days and one of permanent pain in one leg at time 1 year, which remained bearable. For the TVT-O group the post-operative complications consisted in: one case of urinary tract infection, one of transient retention and four of pain in the thigh. No hematoma was reported in either group. Amongst the late complications, the de novo symptoms included one case of imperious urges to urinate in the TVT-O group and objective dysuria in two cases in the MON group versus seven in the TVT-O group. There was no statistically significant between-group difference in the complications. No tape exposure was observed. Overall, the recovery rate was 90% at 1 year for MON versus 94% for TVT-O (p=NS) with two cases of recurrence between 3 months and 1 year in that series. Mixed incontinence was corrected at time point 1 year in 75% of cases for MON, with one case of recurrence in the year. For the patients presenting with sphincter incompetence, competence was maintained at 3 months and 1 year in all cases in the MON group. The three TVT-O were cured at 3 months, but two recurrences were observed at 1 year. Almost all the patients were satisfied or very satisfied at time point 1 year and those who had sexual relations (54%) did not report any disorder at time point 1 year. DISCUSSION: The outside-in technique necessitates more marked peri-urethral dissection and vesical complications are possible. The cadaveric studies by the outside-in partisans show a vascular and nervous risk, which has little reflection in terms of complications in the literature. Post-operative leg pains are encountered with both techniques and are usually only transient. All the studies of the two routes report a recovery rate of over 90% for pure stress incontinence. CONCLUSION: The author's experience, like that reported in the literature, shows that the two trans-obturator access routes are equally safe and do not require per-operative cystoscopic control. The clinical results would appear to be equivalent, in terms of recovery, to the rates obtained with retropubic TVT. Attempting to find anatomical or etiological arguments in order to prove one technique superior to the other appears somewhat parochial.

Transvaginal mesh technique for pelvic organ prolapse repair: mesh exposure management and risk factors.

Prosthetic reinforcement in the surgical repair of pelvic prolapse by the vaginal approach is not devoid of tolerability-related problems such as vaginal erosion. The purposes of our study are to define the risk factors for exposure of the mesh material, to describe advances and to recommend a therapeutic strategy. Two hundred and seventy-seven patients undergoing surgery due to pelvic prolapse with transvaginal mesh technique were included in a continuous, retrospective study between January 2002 and December 2003. Thirty-four cases of mesh exposure were observed within the 2 months following surgery, which represents an incidence of 12.27%. All the patients were medically treated, nine of whom were found to have completely healed during the check-up performed at 2 months. In contrast, 25 patients required partial mesh exeresis. Risk factors of erosion were concomitant hysterectomy [OR = 5.17 (p = 10(-3))] and inverted T colpotomy [OR = 6.06 (p = 10(-2))]. Two technical guidelines can be defined from this study as regards the surgical procedure required in order to limit mesh exposure via the vaginal route. The uterus must be preserved, and the number and extent of colpotomies needed to insert the mesh must be limited.

Mechanical properties of synthetic implants used in the repair of prolapse and urinary incontinence in women: which is the ideal material?

The authors review the literature concerning all types of synthetics implants used in prolapse repair or the treatment of stress urinary incontinence, and analyze the mechanical properties of and the tolerance to the various products used. Various synthetic implants are also studied, including their advantages and disadvantages, as well as outcome following implantation and tolerance by the host, with respect to the type of product and the type of intervention. A review of current implant products demonstrated that the perfect product does not exist at present. The most promising of theses products for applications in transvaginal surgery to restore pelvic function appears to be the synthetic prostheses made predominantly of polypropylene, which offer mechanical properties of durability and elasticity. Their properties of resistance are undisputed, but it remains to be shown whether they are well tolerated when inserted by the vaginal route. The technical modalities for their use are still under evaluation, which should enable a better identification of the respective indications for these products in prolapse repair and treatment of urinary incontinence by the vaginal route.

Tension-free vaginal tape (TVT) in the treatment of urinary stress incontinence: 3 years experience involving 256 operations.

OBJECTIVES: To report the outcome and complications of a series of tension-free vaginal tape (TVT) operations and compare the results with the literature. MATERIALS AND METHODS: A total of 256 cases with a minimum follow-up time of 3 months (May 1998-September 2001) were included (193 isolated TVT, 23 combined with vaginal hysterectomy and 63 combined with prolapse surgery). These cases included 21% of the patients presenting with mixed incontinence, 14% with sphincter deficiency and 9.8% with recurrent incontinence. The isolated TVT were carried out under local anesthesia an ambulatory procedure, the others were done under spinal anesthesia. RESULTS: Almost all the patients underwent a clinical check-up after 3 months and 1 year and also underwent urodynamic exploration; they were then questioned by means of a questionnaire after 2 and 3 years. The global cure rate was 90, 91, 83 and 87%, respectively. The authors observed 6.4% of recurrences between 3 months and 1 year and 7.2% between 2 and 3 years. For mixed incontinence at the three first check-ups, the cure rate was 75, 85 and 60%, respectively, with 7.4 and 20% of recurrences between these two intervals. The cure rates of the patients who had presented with sphincter deficiency were 76, 79 and 73%, respectively, with 16% recurrences during the first year. In the case of recurrent incontinence, a cure was obtained in 72 and 71% of cases, with 18% of recurrences. The complications consisted of 5.5% cases of perforated bladder, 0.4% hematomas of the Retropubic space, 3.1% urinary infections, 0.4% urethral injuries, 5.1% transient urine retention, 12.0% de novo urinary urgency and 20% de novo dysuria. It should be noted that half of the pre-operative urgencies had disappeared after the operation. No defective healing and rejection phenomenon was observed. DISCUSSION: The authors reviewed the results reported in 35 articles, and compare these with their own results. They also reviewed all the complications encountered, account for them and suggested how they can be avoided. There are discrepancies between the various studies, particularly with regard to the complications. CONCLUSION: This minimally invasive operation should be further assessed so that it can demonstrate its effectiveness, and become the "Gold standard". Randomized studies are awaited with this in view.