Impact of a mid-urethral synthetic mesh sling on long-term risk of systemic conditions in women with stress urinary incontinence: a national cohort study.

OBJECTIVE: To compare the incidence of systemic conditions between women who had surgical treatment for stress incontinence with mesh and without mesh. DESIGN: National cohort study. SETTING: English National Health Service. POPULATION: Women with no previous record of systemic disease who had first-time urinary incontinence surgery between 1 January 2006 and 31 December 2013, followed up to the earliest of 10 years or 31 March 2019. METHODS: Competing-risks regression was used to estimate hazard ratios (HR), adjusted for patient characteristics, with HR > 1 indicating increased incidence following mesh surgery. MAIN OUTCOME MEASURES: First postoperative admission with a record of autoimmune disease, fibromyalgia or myalgic encephalomyelitis up to 10 years following the first incontinence procedure. RESULTS: The cohort included 88 947 women who had mesh surgery and 3389 women who had non-mesh surgery. Both treatment groups were similar with respect to age, socio-economic deprivation, comorbidity and ethnicity. The 10-year cumulative incidence of autoimmune disease, fibromyalgia or myalgic encephalomyelitis was 8.1% (95% CI 7.9-8.3%) in the mesh group and 9.0% (95% CI 8.0-10.1%) in the non-mesh group (adjusted HR 0.89, 95% CI 0.79-1.01; P = 0.07). A sensitivity analysis including only autoimmune diseases as an outcome returned a similar result. CONCLUSIONS: These findings do not support claims that synthetic mesh slings cause systemic disease. TWEETABLE ABSTRACT: No evidence of increased risk of systemic conditions after stress incontinence treatment with a mesh sling.

Long-term efficacy and complications of a multicentre randomised controlled trial comparing retropubic and transobturator mid-urethral slings: a prospective observational study.

OBJECTIVE: There are concerns regarding the risks of mid-urethral slings (MUS) for stress urinary incontinence (SUI), particularly because of the lack of long-term data. We compare patient-reported outcomes of a multicentre randomised controlled trial of retropubic (TVT, GYNECARE™) versus transobturator (TOT, MONARC™) tape surgery at 12 years. DESIGN AND SETTING: A multicentre study was performed in 11 tertiary referral centres. POPULATION: A cohort of 180 participants from the original trial, the majority of whom had mixed urinary incontinence. METHODS: Postal questionnaire survey of patient-reported outcome measures using the International Consultation on Incontinence Questionnaire, Patient Global Impression of Improvement questionnaire (PGI-I) and a numeric rating scale pain questionnaire. MAIN OUTCOME MEASURES: Comparison of the efficacy and complications between the TVT and TOT procedures in the long term. RESULTS: A total of 110/180 responses were received: 55 for TVT and 55 for TOT. The mean follow-up was 12.8 ± 0.29 years (SD). TVT was significantly superior to TOT: 41.8% TVT with no SUI, versus 21.8% TOT (P = 0.04). Urgency urinary incontinence (UUI) was the most bothersome urinary symptom: 14.5% of respondents reported UUI after TVT and TOT. This was an improvement from the baseline levels: 61.8% TVT and 76.4% TOT. Seventeen patients (9 TVT and 8 TOT) out of 121 reported moderate or severe pain with severe pain in 3 with TVT and 2 with TOT. Overall, 80% TVT and 77% TOT participants reported their symptoms as improved on the PGI-I. CONCLUSIONS: TVT is superior to TOT for SUI cure. Efficacy is reduced by 12 years. There is low incidence of severe vaginal or groin pain. Careful patient counselling on long-term outcomes is required. The Retropubic tape appears to be an effective treatment for the majority of women with SUI. TWEETABLE ABSTRACT: Retropubic tape has superior efficacy to transobturator tape. Complications are comparable with low rates.

Cost-effectiveness of behavioral and pelvic floor muscle therapy combined with midurethral sling surgery vs surgery alone among women with mixed urinary incontinence: results of the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence randomized trial.

BACKGROUND: Urinary incontinence is prevalent among women, and it has a substantial economic impact. Mixed urinary incontinence, with both stress and urgency urinary incontinence symptoms, has a greater adverse impact on quality of life and is more complex to treat than either stress or urgency urinary incontinence alone. Studies evaluating the cost-effectiveness of treating both the stress and urgency urinary incontinence components simultaneously are lacking. OBJECTIVE: Cost-effectiveness was assessed between perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery and midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. The impact of baseline severe urgency urinary incontinence symptoms on cost-effectiveness was assessed. STUDY DESIGN: This prospective economic evaluation was performed concurrently with the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence randomized trial that was conducted from October 2013 to April 2016. Participants included 480 women with moderate-to-severe stress and urgency urinary incontinence symptoms and at least 1 stress urinary incontinence episode and 1 urgency urinary incontinence episode on a 3-day bladder diary. The primary within-trial analysis was from the healthcare sector and societal perspectives, with a 1-year time horizon. Costs were in 2019 US dollars. Effectiveness was measured in quality-adjusted life-years and reductions in urinary incontinence episodes per day. Incremental cost-effectiveness ratios of combined treatment vs midurethral sling surgery alone were calculated, and cost-effectiveness acceptability curves were generated. Analysis was performed for the overall study population and subgroup of women with Urogenital Distress Inventory irritative scores of ≥50th percentile. RESULTS: The costs for combined treatment were higher than the cost for midurethral sling surgery alone from both the healthcare sector perspective ($5100 [95% confidence interval, $5000-$5190] vs $4470 [95% confidence interval, $4330-$4620]; P<.01) and the societal perspective ($9260 [95% confidence interval, $8590-$9940] vs $8090 [95% confidence interval, $7630-$8560]; P<.01). There was no difference between combined treatment and midurethral sling surgery alone in quality-adjusted life-years (0.87 [95% confidence interval, 0.86-0.89] vs 0.87 [95% confidence interval, 0.86-0.89]; P=.90) or mean reduction in urinary incontinence episodes per day (-4.76 [95% confidence interval, -4.51 to 5.00] vs -4.50 [95% confidence interval, -4.25 to 4.75]; P=.13). When evaluating the overall study population, from both the healthcare sector and societal perspectives, midurethral sling surgery alone was superior to combined treatment. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone is ≤28% from the healthcare sector and ≤19% from the societal perspectives for a willingness-to-pay value of ≤$150,000 per quality-adjusted life-years. For women with baseline Urogenital Distress Inventory irritative scores of ≥50th percentile, combined treatment was cost-effective compared with midurethral sling surgery alone from both the healthcare sector and societal perspectives. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone for this subgroup is ≥90% from both the healthcare sector and societal perspectives, at a willingness-to-pay value of ≥$150,000 per quality-adjusted life-years. CONCLUSION: Overall, perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery was not cost-effective compared with midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. However, combined treatment was of good value compared with midurethral sling surgery alone for women with baseline severe urgency urinary incontinence symptoms.

[Trends in the use of midurethral slings after the new legislation: A nationwide survey]. / Évolution des pratiques après l'arrêté encadrant les bandelettes sous-urétrales : résultats d'une enquête nationale.

INTRODUCTION: The French Department of Health published on October 23, 2020 a decree governing acts associated with mid-urethral sling (MUS) operations. The aim of this study was to evaluate the changes in practice following this new legislation. METHODS: A cross-sectional study was carried out among French urologists and gynecologists using an online survey to collect changes in practices since the publication of the decree. RESULTS: From January to February 2021, 436 surgeons participated in the survey. Among these surgeons, 87% were aware of the new legislation and 56% of them considered the decree as useless. The order resulted in an increase in working time in 81% of cases. Among these surgeons, 66% of the surgeons worked in tertiary referral centers for the management of incontinence, of which 55% had a multidisciplinary meeting in urogynecology. Among the surgeons, 31% considered this meeting to be useful but 80% considered that it did not lead to any change in surgical indications, even though 33% of complications of BSU were discussed there. In conclusion, 61% of surgeons felt more reluctant to schedule a BSU placement with this new legislation. CONCLUSION: The majority of questioned surgeons considered the decree as useless. It generated few changes in practices which already respected the law on information, consultation, consent, experience and training. Most urologists and gynecologists are more reluctant to offer MUS after this new legislation. LEVEL OF EVIDENCE: 4.

Association Between Hemoglobin A1c and Midurethral Sling Complications in Diabetic Women: A Cohort Study.

OBJECTIVE: We aimed to evaluate the association between hemoglobin A1c (HbA1c) levels and midurethral sling (MUS) complications. METHODS: This was a multihospital, retrospective cohort study from 2010 to 2020. We included all women with diabetes mellitus who underwent a synthetic mesh MUS procedure and had a preoperative HbA1c within 3 months of surgery. The primary outcome was a composite of complications, including MUS mesh exposure, surgical site granulation tissue or infection, urinary tract infection, surgical site pain beyond 6 weeks postoperatively, and MUS failure. A sensitivity analysis analyzing MUS failure alone was performed. RESULTS: During the study period, 109 women met the inclusion criteria. Most were White (52.2%) and had a median body mass index of 31.2 kg/m2, and 84.9% were postmenopausal. Median HbA1c was 7.2% (interquartile range, 6.3%-7.7%). Urinary tract infection was the most common complication in 12 (11.0%) women. Mesh exposure was diagnosed in 7 (6.4%) women. Seventeen (15.6%) had MUS failure. On univariate regression analysis, a higher HbA1c was associated with increased odds of composite complications (odds ratio, 1.67; 95% confidence interval, 1.20-2.32; P = 0.002) and MUS failure (odds ratio, 1.81, 95% confidence interval, 1.26-2.60; P = 0.001). On multivariate analysis, higher HbA1c levels were associated with a composite of complications and failure (P < 0.05). Based on the receiver operating characteristic curve, HbA1c greater than 8% demonstrated a specificity of 85.7% and a sensitivity of 50% for MUS failure. CONCLUSIONS: In diabetic patients, a higher HbA1c was associated with a higher risk of MUS complications and failure. Obtaining an HbA1c within 3 months of surgery may help with risk stratification.

Trends of Mesh Utilization for Stress Urinary Incontinence Before and After the 2011 Food and Drug Administration Notification Between FPMRS-Certified and Non-FPMRS-Certified Physicians: A Statewide All-Payer Database Analysis.

OBJECTIVES: To investigate the utilization of mesh slings for stress urinary incontinence (SUI) across time - before and after the 2011 US Food and Drug Administration (FDA) public health notification regarding an increase in adverse events related to transvaginal mesh (TVM) for pelvic organ prolapse (POP) repair - and among FPMRS-certified urologists and gynecologists and non-FPMRS counterparts using a statewide database. METHODS: The New York Statewide Planning and Research Cooperative System all-payer database was utilized to extract outpatient Current Procedural Terminology procedure codes for SUI mesh sling utilization and revision or removal performed between 2007 and 2015. RESULTS: After the 2011 FDA warning on POP with TVM, sling placement decreased by 43% from 5214 cases in 2011 to 2958 in 2015. However, over the study period, the rate of sling revision remained stable relative to total sling placement. The rise and fall in mesh sling usage for SUI was primarily driven by non-FPMRS providers. FPMRS providers performed a higher proportion of sling procedures. The number of FPMRS physicians also increased from 2011 to 2015, and each individual physician had a higher median case volume for sling placements and revisions. CONCLUSION: In New York state, utilization of mesh slings for SUI has significantly decreased since the 2011 FDA public health notification, without any specific warning for the utilization of mesh in this setting. This trend was mainly driven by a decrease in mesh usage among non-FPMRS physicians, although the specific causality is likely complex.

Timing and Success of Postoperative Voiding Trial After Colpocleisis With and Without Concomitant Midurethral Sling.

OBJECTIVE: The aim of this study was to compare failure rates of first voiding trial (VT) within 7 days and on postoperative day (POD) 1 after colpocleisis with versus without concomitant midurethral sling (MUS). Predictors of POD 1 VT failure were also examined. METHODS: This was a retrospective cohort study of women undergoing colpocleisis from January 2012 to October 2019 comparing VT outcomes with versus without MUS. Primary outcome was first VT failure within 7 days; outcomes of VTs performed on POD 1 were also assessed. Association between MUS and VT failure and predictors of POD 1 VT failure were assessed via logistic regression. RESULTS: Of 119 women, 45.4% had concomitant MUS. First VT was performed on mean POD 3.1 ± 2.2 in the MUS group versus POD 1.8 ± 1.8 in the no MUS group (P < 0.01). The MUS group was less likely to undergo POD 1 VT (50% vs 83%, P < 0.01). Failure of the first VT did not differ (22.2% with MUS vs 32.8% without MUS, P = 0.20); no association between VT failure and MUS was noted (adjusted odds ratio [aOR], 0.6; 95% confidence interval [CI], 0.18-2.1). There were 68.1% (81/119) of participants who underwent POD 1 VT, MUS was performed in 33.3% (27/81). The POD 1 failure did not differ between those with 33.3% versus 40.7% without MUS (P = 0.52). Midurethral sling was not associated with POD 1 VT failure (aOR, 0.93; 95% CI, 0.27-3.23). In women undergoing POD 1 VT, preoperative postvoid residual was associated with VT failure (aOR, 1.39; 95% CI, 1.01-1.92). CONCLUSIONS: In women undergoing colpocleisis, MUS was not associated with VT failure within 7 days or on POD 1. Increased preoperative postvoid residual was associated with POD 1 VT failure.

Risk Factors for Intraoperative Bladder Perforation at the Time of Midurethral Sling Placement.

OBJECTIVE: To evaluate patient-specific and perioperative factors that may be predictive of bladder perforation during midurethral sling placement. METHODS: A retrospective chart review of women who underwent a midurethral sling procedure at our institution between 2013 and 2017 was completed. All cases with bladder perforation were included. Patient demographics and perioperative factors were explored for associations with perforation. Bivariate analysis was used to compare baseline characteristics between those with and without perforation. Logistic regression modeling was used to identify predictors of perforation and associations between bladder perforation and postoperative sequelae. RESULTS: Four hundred and ten women had a urethral sling procedure at our institution between 2013 and 2017. Of these, 35 (9%) had evidence of bladder perforation on cystoscopy. This rate was higher for retropubic slings (15%) compared to transobturator slings (2%). Those with a perforation were younger (54 vs 61 years, P= .004) and had a lower average BMI (24.1 kg/m2 vs 26.3 kg/m2, P = .022). Other risk factors included lack of pre-existing apical prolapse (11% vs 4%, P = .012) and concomitant urethrolysis (27% vs 8%, P = .024). In multivariable analysis, age, BMI, and sling type were significantly associated with perforation. In univariate analysis, perforation was associated with postoperative lower urinary tract symptoms (OR 2.3, P = .21) and urinary tract infection within 30 days of surgery (OR 2.2, P = .047). CONCLUSIONS: Intraoperative bladder perforation was associated with younger patient age and lower BMI. Additionally, bladder perforation is a risk factor for postoperative urinary tract infection and lower urinary tract symptoms.

Rates of Sling Procedures and Revisions-A National Surgical Quality Improvement Program Database Study.

OBJECTIVE: The aim of this study was to describe trends in sling procedures and revisions, including fascial slings and midurethral slings (MUS) using a large, national database with respect to the 2011 U.S. Food and Drug Administration (FDA) mesh-related safety communication. METHODS: This was a cross-sectional cohort study using data from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database from 2010 to 2018, evaluating the prevalence of sling revision and fascial slings and their trends over time. Patients who underwent MUS, fascial slings, and sling revisions were identified by Current Procedural Terminology codes. Sling revisions and fascial slings were evaluated as a proportion of the total number of MUS performed per year. Three distinct periods were evaluated in relation to the 2011 FDA communication: 2010 to 2012, 2012 to 2015, and 2015 to 2018. Observed trends were assessed with Pearson correlation coefficients with a P value less than 0.05 considered significant. RESULTS: During the study period, 32,657 slings were captured: 32,389 MUS and 268 fascial slings. The rate of sling revisions was low (0.4% in 2010 to 1.2% in 2015). Between 2012 and 2015, the rate of sling revision increased significantly (R = 1, P = 0.002); following 2015, the rate of sling revisions decreased significantly over time (R = -0.96, P = 0.04). The rate of fascial slings between 2012 and 2015 increased significantly (R = 0.95, P = 0.047); however, the rate plateaued starting in 2015 (R = -0.49, -P = 0.51). CONCLUSIONS: Our data suggest that MUS remain the preferred procedure for treatment of stress urinary incontinence despite the recent FDA communications with MUS representing 99% of sling procedures during the study period.

Cadaveric Laboratory Simulation Training of Male Stress Urinary Incontinence Treatment Improves Trainee Knowledge and Confidence.

OBJECTIVE: To assess whether a focused, simulation training course can improve trainee surgical knowledge and confidence in the treatment of male stress urinary incontinence. MATERIALS AND METHODS: Urology residents participated in a prosthetic education course as part of the 2018 SUPS and SMSNA annual meeting. The course included didactic lectures and a hands-on cadaveric laboratory. Participants completed questionnaires before and after the lab (2 weeks and 6 months) to assess procedural knowledge and confidence. Analysis of lab responses was performed using the Wilcoxon signed rank test for matched pairs. RESULTS: Thirty-two residents (median age 29, range 27-34) participated in the course. The majority were postgraduate year 4 (63%) or postgraduate year 5 (20%). Most participants reported minimal AUS or sling experience with 50% and 94% reporting less than 5 cases, respectively. Overall score from the knowledge assessment improved significantly between the pre-lab versus 2-week post-lab (P = .02) and pre-lab versus 6-month post-lab (P = .01). Similarly, procedural confidence improved between pre-lab vs 2-week post-lab (P < .001) and pre-lab versus 6-month post-lab (P < .001). Knowledge and confidence assessments were not different between year of residency training or pre-lab experience. CONCLUSIONS: Simulation training improves knowledge and confidence in prosthetic surgery for male stress incontinence. In the current climate of reduced exposure and limited availability of prosthetic educators, simulation courses can provide much needed educational value.