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.

Perceived health status after mid-urethral sling revision in 287 women from the VIGI-MESH registry: A cross-sectional study.

OBJECTIVE: To evaluate the health status and recovery of women after mid-urethral sling (MUS) revision in response to complications. DESIGN: Cross-sectional study using a questionnaire sent to women from a registry. SETTING: Twenty-two French surgical centres. POPULATION: A total of 287 women from the VIGI-MESH registry responded, having undergone MUS revision for complications. METHODS: Our sample of women were compared against a representative set of French women taken from the Eurostat database. Multivariate analysis was performed to identify clinical predictors for successful MUS revision. A qualitative analysis was carried out on free-text comments. MAIN OUTCOME MEASURES: Health status, defined by the Minimum European Health Module, and recovery, assessed by Patient Global Impression of Improvement. RESULTS: The response rate was 76% (287/378), with 49% of the women (141/287, 95% CI 43%-55%) reporting good health status, which was 8 points lower than that expected from the comparator French set (57%, 95% CI 55%-58%). Overall, 53% (147/275, 95% CI 47%-59%) of the women reported feeling much better after MUS revision. Just over one-third (35%, 95/275, 95% CI 29%-40%) of respondents reported poor health with little or no improvement. Multivariate analysis showed that being operated on for pain at revision was associated with worse self-perceived health than being operated on for exposure (OR 0.6, 95% CI 0.14-0.95); women with pre-existing comorbidity reported a poorer health status following MUS revision (OR 0.22, 95% CI 0.13-0.38). CONCLUSIONS: Our results suggest that half of the women recovered good health status after MUS revision, whereas a proportion appeared to be seriously affected by an MUS complication despite the revision.

Urinary and sexual impact of pelvic reconstructive surgery for genital prolapse by surgical route. A randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The main objective of the study was to evaluate the rates of de novo stress urinary (SUI) and postoperative dyspareunia after both sacrocolpopexy/hysteropexy (SCP) and vaginal mesh surgery. METHODS: A prospective, multicenter, randomized, open-label study with two parallel groups treated by either SCP or Uphold Lite vaginal mesh was carried out. Study participants were ≥ 50 and < 80 years old patients with Pelvic Organ Prolapse Quantification (POP-Q) stage ≥2 who were considered eligible for reconstructive surgery and who were sexually active with no dyspareunia and free from bothersome SUI at presentation. Women were assessed before surgery and at 4-8 weeks and 11-13 months after using validated measures including POP-Q, Pelvic Floor Disability Index (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), and Patient Global Impression of Improvement (PGI-I). Data were also collected for health economics evaluation. RESULTS: Of the required sample of 156 women, 42 women (19 SCP and 23 vaginal mesh) were only recruited owing to the discontinuation of vaginal mesh worldwide. The median follow-up was 376 days. The rates of bothersome de novo SUI were similar in the SCP and Uphold vaginal mesh groups (15.79 vs 15.00%, OR 0.95 [95% CI 0.22-4.14]). Among 30 sexually active patients at follow-up, the rates of women reporting de novo dyspareunia "usually or always" were 6.7% after SCP vs 13.3% after vaginal mesh (p = 1). Health economics evaluation showed a cost saving of 280€ in favor of the Uphold vaginal mesh technique, but no significant difference in the total cost (2,934.97€ for SCP vs 3,053.26€ for Uphold vaginal mesh). CONCLUSIONS: Bothersome de novo SUI and de novo dyspareunia occurred in approximately 15% and 23% of our study cohorts, with no significant difference between sacrocolpopexy/hysteropexy and anterior/apical vaginal mesh surgery. However, these results should be interpreted with caution owing to the small sample size.

Prospective ultrasonographic follow-up of transvaginal lightweight meshes: a 1-year multicenter study.

INTRODUCTION AND HYPOTHESIS: The use of new lightweight meshes in pelvic organ prolapse (POP) surgery may reduce complications related to mesh retraction (chronic pain, dyspareunia, and mesh exposure). The aim of this study was to investigate changes in the area and position of Uphold Lite™ mesh 6 weeks and 12 months after anterior and/or apical prolapse repair. METHODS: This observational prospective multicenter study included patients who had undergone transvaginal surgery for symptomatic POP-Q stage ≥ II anterior and/or apical compartment prolapse with placement of Uphold Lite mesh. The dimensions and position of the mesh were evaluated at 6 weeks and 12 months by ultrasonography. Correlations between ultrasonographic mesh characteristics and POP recurrence were analyzed. RESULTS: Fifty evaluable women with an average age of 66.8 years were included. No statistically significant difference in mesh area was found between week 6 and month 12 postoperatively, either at rest (1746.92 vs. 1574.48 mm2; p = 0.15) or on Valsalva (1568.81 vs. 1542.98 mm2; p = 0.65). The ROC-AUC of the distance between the mesh and the bladder neck (M-BN) at 6 weeks for predicting cystocele recurrence at 12 months was 0.764 (95% CI 0.573-0.955) at rest and 0.724 (95% CI 0.533-0.916) on Valsalva. An M-BN distance > 12.5 mm could predict cystocele recurrence at month 12 with a sensitivity of 80% and a specificity of 69%. CONCLUSIONS: Ultrasonographic measurements of the Uphold Lite™ mesh appear to remain stable between 6 weeks and 12 months postoperatively. M-BN distance correlates with cystocele recurrence. These results appear to confirm the value of ultrasound in mesh evaluation.

A retrospective comparison of two vaginal mesh kits in the management of anterior and apical vaginal prolapse: long-term results for apical fixation and quality of life.

INTRODUCTION AND HYPOTHESIS: To compare apical correction in stage ≥3 cystocele between two mesh kits. METHODS: This was a retrospective, nonrandomized study that compared two groups matched on anterior/apical POP-Q stage: 84 received Elevate Ant™ single-incision mesh (Elevate Ant group) and 42 Perigee™ transvaginal mesh (Perigee group). Follow-up at 1 and 2 years comprised objective (POP-Q) and subjective (PFDI-20, PFIQ-7, PISQ-12) assessments. The primary endpoint was objective success: 2-year apical POP-Q stage ≤1. Secondary endpoints were anterior POP-Q stage, subjective results and complications. RESULTS: Groups were comparable in terms of age (66.6 and 64.7 years, respectively; p = 0.19), BMI (both 25.4 kg/m2; p = 0.93), and history of hysterectomy (7.2 % and 14.3 %; p = 0.21) or prolapse surgery (12 % and 14.3 %; p = 0.72). Operative time was shorter in the Elevate Ant group (54.1 vs. 62.5 min; p = 0.048), and the 2-year objective apical success rate was higher (92.9 % vs. 66.7 %; p < 0.0001), with better point C correction (-5 vs. -3.8; p = 0.006). Function improved in both groups, with significantly better PFIQ-7 (p = 0.03) and PFDI-20 (p = 0.02) scores in the Elevate Ant group at 2 years. Vaginal exposure was not seen in the Elevate Ant group but occurred in two patients in the Perigee group (p = 0.33). Factors associated with success were age >65 years (OR 7.16, 95 % CI 1.83 - 27.97) and treatment with Elevate Ant mesh (OR 10.16, 95 % CI 2.78 - 37.14). Postoperative stress urinary incontinence rate was greater with the Elevate Ant group (29.8 % and 16.7 %; p = 0.11). CONCLUSIONS: The use of the Elevate Ant mesh was associated with significantly better apical correction at 2 years. Function improved in both groups, but with a significantly better PFDI-20 score in the Elevate Ant group at 1 and 2 years. The postoperative stress urinary incontinence rate, however, tended to be greater in the Elevate Ant group. The results need confirming with longer follow-up of these cohorts and in randomized studies.

Anterior and Apical Prolapse: Comparison of Vaginal Mesh Surgery to Vaginal Surgery with No Mesh.

AIM OF THE STUDY: The aim of this study was to evaluate the anatomical results after an anterior sacrospinous ligament fixation (ASSLF) with native tissue repair (anterior colporraphy and apical suspension with prolene) compared to mesh repair for the correction of anterior prolapse at 12 months after surgery. MATERIALS AND METHODS: A monocentric prospective study comparing two similar cohorts who underwent ASSLF was conducted. The primary endpoint was the gain in the position of the Ba point relative to its position before surgery and twelve months after surgery. The secondary endpoints consisted of objective results, which were assessed using validated questionnaires. RESULTS: Fifty-three women were included in the native tissue repair group between June 2019 and March 2020. They were compared to 53 women operated on with anterior and apical mesh. There was no difference with respect to the Ba point after 1 year between the two groups (-2 [-3; 1.5]; -2 [-3; 1], p = 0.9789). The apex was significantly better corrected in the native tissue repair group (-7 vs. -6, p = 0.0007). There was also a better correction on the rectocele in the native tissue repair group (-3 vs. -2, p = 0.0178). The rate of Stage 2 anterior vaginal prolapse at one year was approximately 30% in both groups (no statistical difference). CONCLUSIONS: ASSFL without mesh does not increase the risk of cystocele recurrence at 1 year after surgery. A future prospective comparison of this native tissue repair technique with mesh suspension is necessary to explore these preliminary findings.

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.

Outpatient vaginal surgery for pelvic organ prolapse: a prospective feasibility study.

BACKGROUND: In the light of recent progress in pelvic organ prolapse surgery, the modalities of hospital admission need reconsidering. This work aims to assess success rate of outpatient (ambulatory) vaginal mesh surgery for genital prolapse. METHODS: A prospective observational study was conducted between January 2015 and July 2017, including all patients presenting with POP-Q stage ≥3 anterior and/or apical prolapse. RESULTS: Sixty-nine of the 89 eligible patients were treated on an ambulatory basis (group A); 20 required overnight admission (group B): i.e., ambulatory success rate, 77.5%. Mean operative time was 44.9±2.5 min in group A and 62±6.5 min in group B. Reasons for ineligibility for ambulatory management comprised organizational issues at home (10.5%) and excessive home-to-hospital distance (5.7%). The postoperative urinary retention rate was 4.5%. Rates for successful cystocele correction (POP-Q <2) at 2 months were similar in the two groups: 94.2% in group A and 94.4% in group B (P=ns). Mean satisfaction score was 8.6±0.3/10. CONCLUSIONS: Outpatient anterior vaginal mesh surgery for prolapse is safe and effective. The current medical-economic context favors ambulatory management. Patient selection, prior information and continuity of care seem primordial.

Prospective feasability study of ambulatory surgery for pelvic organ prolapse.

STUDY OBJECTIVE: The aim of this study was the evaluation of ambulatory surgery (AS) rate for pelvic organ prolapse (POP). DESIGN: It was a prospective observational study. DESIGN CLASSIFICATION: Level II-2. SETTING: Patients were divided in two groups: Group EAS: patients eligible to ambulatory surgery and Group NEAS: patients not eligible to AS. PATIENTS: all patients from August 2015 to November 2016 undergoing surgery for POP in our institution. MEASUREMENTS: The main outcome was overall AS rate in the population. Secondary outcomes were in NEAS group: reasons for ineligibility; in EAS group: AS success rate, reasons of failure and patient satisfaction related to AS; in each group: post operative re-admission or consultation, morbidity and global satisfaction. MAIN RESULTS: There was 157patients included in the study. Eligibility criteria for AS was met for 111/157 (707%). Overall AS rate was 58% and success rate of AS was 82%. Reasons for ineligibility to AS were lack of home support (50%), home >1 h from hospital (109%), poor home conditions (2,2%), associated comorbidity (21.7%), associated procedure (4,3%) and refusal for AS (109%). Reasons for failure (20/111, 18%) of AS were unsuccessful trial of void (TOV) (65%), post operative nausea-vomiting (PONV) (15%), sub-cutaneous emphysema (5%), post-operative bleeding (5%) and faulty organization (10%). There was no unscheduled re-admission the night after surgery in EAS group. 7,2% in EAS group and 13% in the NEAS group had an unscheduled consultation. There were 4 re-admissions (3,6%) in the EAS group and 1 (2,2%) in the NEAS group during follow-up. Patient satisfaction to AS was 100% on next-day call and 923% at 6 weeks. CONCLUSION: Ambulatory surgery rate was 58% in this population of surgically managed prolapses; AS success rate was 82%. There was no adverse events related to AS and patient satisfaction to AS at 6 weeks is high.

Long-term follow-up of patients treated by transvaginal mesh repair for anterior prolapse.

OBJECTIVE: The aim of the study was to assess 5 years outcome of transvaginal single incision mesh surgery (SIMS) for anterior pelvic organ prolapse (POP). STUDY DESIGN: This was a prospective study including all patients from January 2009 to December 2012 who underwent SIMS for symptomatic anterior prolapse stage ≥2, according to POP Quantification (POP-Q). Symptoms and quality of life were assessed using validated questionnaires: Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact questionnaire (PFIQ-7), and Prolapse/ Incontinence Sexual Questionnaire (PISQ-12). Main outcome was subjective success (question 3 of PFDI-20 score = 0). Mesh-related complications, objective and functional outcomes were used as the secondary outcomes. RESULTS: 270 patients were included in the study. Median follow-up was 5,7 years [4,5-8,2]. Subjective success rate was 86,6% at 5 years. Objective success rate was 53,1% at 5 years. At 5 years, composite failure (subjective + objective) occurred for 17 patients (12%), 7 patients with direct recurrence and 10 with indirect recurrence. Re-treatment was performed in six patients (2,8%; 3 hysterectomies for apical recurrence and 3 posterior repairs for posterior recurrence). One case (0,4%) of asymptomatic mesh exposure occurred. The reoperation rate for mesh-related complications was 3,4%. At 5 years, de novo dyspareunia rate was 11,7%, 3,9% considered as mesh-related. A significant improvement was noted for symptoms and quality of life. CONCLUSION: Five-year results demonstrate that vaginal mesh surgery provides a durable and safe repair of anterior compartment prolapse with a low rate of mesh-related complications and reoperations. Between the 2- and 5-year follow-up, patient satisfaction and associated improvements in prolapse-specific symptoms were sustained and minimal new morbidity occurred.

Two years follow up of 270 patients treated by transvaginal mesh for anterior and/or apical prolapse.

OBJECTIVE: The aim of this study was to assess the 1 and 2 years outcomes of transvaginal single incision mesh surgery (SIMS) for anterior pelvic organ prolapse (POP). MATERIAL AND METHODS: This was a prospective study including all patients from November 2008 to December 2012 who underwent SIMS for symptomatic anterior prolapse stage≥2, according to the POP Quantification (POP-Q). Symptoms and quality of life were assessed using validated questionnaires: Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact questionnaire (PFIQ-7), and Prolapse/Incontinence Sexual Questionnaire (PISQ-12). The main outcome was subjective success (question 3 of PFDI-20 score=0). Safety, anatomic and functional outcomes were used as the secondary outcomes. RESULTS: A total of 270 patients were included in the study. Subjective success rate was 95,4% and 92,2% at 1 and 2 years. Objective success rate was 65,9%and 60,5% at 1 and 2 years. At 1year, composite failure (subjective+objective) occurred for 11 patients (4,6%), 5 patients with direct recurrence and 6 with indirect recurrence. At 2 years, composite failure was reported for 14 patients (6,4%): 6 direct recurrences and 8 indirect recurrences. Re-treatment was performed in one case (0,4%). One case (0,4%) of asymptomatic mesh exposure occurred. The reoperation rate for mesh-related complications was 3%. We reported a de novo dyspareunia rate of 8,4%, 5,3% considered as mesh-related. A significant improvement was noted for symptoms and quality of life. CONCLUSION: POP repair using SIMS is a safe and efficient treatment of anterior compartment prolapse in the medium term with a low rate of mesh-related complications. Longer-term follow-up is ongoing.

How to advise a woman who wants to get pregnant after a sub-urethral tape placement?

Our objective was to make recommendations for the follow-up of pregnancies and the choice of delivery route for patients becoming pregnant after surgical treatment of stress urinary incontinence (SUI) by tension-free vaginal tape (TVT) or trans-obturator tape (TOT). We performed a retrospective survey on pregnancies after surgical treatment of SUI. Nineteen physicians out of 3,400 contacted reported a total of 20 pregnancies after TVT or TOT. Three patients had recurrent SUI during pregnancy. No major complications of the tape occurred during pregnancy. Ten patients out of 20 delivered vaginally, and nine had a caesarean section. Mean follow-up after delivery was 13.8 months (1 to 52). Recurrence of SUI was observed in 3 of 20 (15%) during pregnancy and in 3 of 18 (16.7%) after delivery. The global rate of recurrence was 4 of 18 (22.2%). Recurrence of SUI was two of ten cases after vaginal delivery (20%) and in one of eight after caesarean section (12.5%; p=0.58). Vaginal delivery did not increase the risk of recurrence.