Quality of life and sexual function after tension-free vaginal tape and polyacrylamide hydrogel injection for primary stress urinary incontinence: 3-year follow-up from a randomized clinical trial.

INTRODUCTION AND HYPOTHESIS: To assess quality of life (QoL) and sexual function outcomes at 3 years after tension-free vaginal tape (TVT) and polyacrylamide hydrogel injection (PAHG) for stress urinary incontinence (SUI). METHODS: In this randomized trial comparing TVT (n = 104) and PAHG (n = 108), we assessed changes in QoL and sexuality using the Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire, Short Form (IIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and RAND-36 Item Health Survey (RAND-36) at baseline and at 3 years. This is a secondary analysis of a randomized, noninferiority trial comparing patient satisfaction after TVT and PAHG. RESULTS: In both groups, incontinence-related QoL improved from the baseline (p < 0.00), except for difficulty emptying the bladder and pain/discomfort. Total scores of UDI-6 and IIIQ-7 were lower for TVT compared to PAHG (p < 0.00) indicating better QoL at 3 years. Urinary incontinence with sexual activity or fear of incontinence restricting sexual activity improved in both groups (p < 0.00), with higher scores for physical section subscale in PISQ-12 (p = 0.02) for TVT. Physical and social functioning (RAND-36) improved from the baseline in both groups (p < 0.01) with a better outcome in the TVT group for physical functioning (p = 0.00). CONCLUSIONS: Both TVT and PAHG improve QoL and sexual function in primary SUI with better incontinence and health-related QoL scores in the TVT group compared to the PAHG group at 3 years.

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.

Risk of reoperation 10 years after surgical treatment for stress urinary incontinence: a national population-based cohort study.

BACKGROUND: There is a debate about the safety and effectiveness of surgical treatments for stress urinary incontinence. Controversy about the use of synthetic mesh sling insertion has led to an increased uptake of retropubic colposuspension and autologous sling procedures. Comparative evidence on the long-term outcomes from these procedures is needed. OBJECTIVE: To compare the risk of reoperation at 10 years after operation between women treated for stress urinary incontinence with retropubic colposuspension, mesh sling insertion, and autologous sling procedures. STUDY DESIGN: The records of admissions to National Health Service hosptials were used to identify women who had first-time stress incontinence surgery between 2006 and 2013 in England. The first incidence of the following outcomes was assessed: further stress incontinence surgery, surgery for a complication (either mesh removal, prolapse repair, or incisional hernia repair), and any reoperation (either further stress incontinence surgery, mesh removal, prolapse repair, or incisional hernia repair). The cumulative incidence of each of these outcomes up to 10 years after surgery was calculated, considering death as a competing event. Multivariable modeling was then used to estimate the reoperation hazard ratios for the different initial surgery types with adjustments for patient characteristics and concurrent prolapse surgery or hysterectomy. RESULTS: The analysis included 2262 women treated with retropubic colposuspension, 92,524 treated with mesh sling insertion, and 1234 treated with autologous sling. The cumulative incidence of any first reoperation at 10 years was 21.3% (95% confidence interval, 19.5-23.0) after retropubic colposuspension, 10.9% (10.7-11.1) after mesh sling insertion, and 12.0% (10.2-13.9) after autologous sling procedures. The women who had a retropubic colposuspension were significantly more likely to have a reoperation than women who had an autologous sling (adjusted hazard ratio for any reoperation: 1.79 [1.47-2.17]; for further stress incontinence surgery: 1.64 [1.19-2.26]; for surgery for complications: 1.89 [1.49-2.40]), whereas the women who had mesh slings had a similar hazard (for any reoperation: 0.90 [0.76-1.07]; for further stress incontinence surgery: 0.75 [0.57-0.99]; for surgery for complications: 1.11 [0.89-1.36]). A sensitivity analysis excluding the women who had concurrent prolapse surgery or hysterectomy produced similar results. CONCLUSION: Retropubic colposuspension is associated with higher risk of reoperation at 10 years after surgery than mesh sling insertion or autologous sling procedures, with 1 in 5 women requiring reoperation.

Quality of life and sexual function after TVT surgery versus Bulkamid injection for primary stress urinary incontinence: 1 year results from a randomized clinical trial.

INTRODUCTION AND HYPOTHESIS: To assess changes in quality of life (QoL) and sexual function outcomes at 1 year after tension-free vaginal tape (TVT) versus polyacrylamide hydrogel injection (PAHG). METHODS: In a randomized trial comparing TVT (n = 111) and PAHG (n = 113) treatments of stress urinary incontinence (SUI), we compared urinary incontinence and health-related QoL using the Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire, Short Form (IIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and RAND-36 Item Health Survey (RAND-36) at baseline and 1 year. RESULTS: UDI-6 and IIQ-7 showed improved incontinence-related QoL (p = 0.001) from baseline in both groups except for difficulty emptying the bladder and pain/discomfort. At 1 year, TVT patients experienced less urinary symptom-related distress compared to PAHG (p < 0.001). Sexual function improved in both groups (p < 0.001 for TVT and p = 0.01 for PAHG) with higher scores for the physical section subscale (p < 0.001) for TVT. Health-related QoL (RAND-36) improved from baseline in both groups in physical and social functioning (p < 0.001) with better outcome in the TVT group for physical functioning (p < 0.001). Increase in pain from baseline (p = 0.02) was detected for TVT, but not for PAHG. However, there was no difference between the groups (p = 0.78). CONCLUSIONS: In primary SUI, TVT and PAHG treatments both improved QoL and sexual function at 1 year. However, incontinence and health-related QoL scores were better in the TVT group. More pain compared to the baseline was reported after TVT, although there was no difference between groups. Clinical significance needs to be evaluated in long-term follow-up.

Current treatments for female primary stress urinary incontinence.

Stress urinary incontinence (SUI) affects millions of women worldwide. Pelvic floor muscle training is the first-line treatment for SUI, and if this fails, midurethral sling surgery has become the gold-standard treatment. More recently, complications from midurethral mesh slings, particularly chronic pain and dyspareunia, have become a major concern. Although traditional SUI treatments, such as colposuspension and fascia slings, are used, the future of SUI treatment likely will rely on less invasive alternatives. Modern bulking agents could have the potential to become a first-line treatment for SUI, but further long-term studies are needed. Patients should be involved in decision-making prior to any surgery to ensure that they are aware of the risks and also any reasonable treatment alternatives. Furthermore, the effectiveness of a procedure should be balanced with its invasiveness and possible risks to provide women individually with the best possible treatment option.

Complications Following the Insertion of Two Synthetic Mid-urethral Slings and Subsequent Removal.

OBJECTIVE: To determine outcomes after removal of two synthetic mid-urethral slings (MUS) at a tertiary care center. METHODS: Following IRB approval, a retrospective chart review of non-neurogenic, symptomatic women requiring re-operation after ≥2 MUS was performed. Data reviewed by a third party included: demographics, prior anti-incontinence surgery, complications, pelvic/urinary symptoms, subsequent investigations, surgical repair and outcomes (including UDI-6/IIQ-7 questionnaires) at a minimum 6 months follow-up. Cure was defined as being continent, no dyspareunia, and no additional surgical therapy. RESULTS: Between 2007 and 2014, 21 women met the inclusion criteria. Mean age was 57 years (range: 40-82) and mean follow-up was 30.2 months (range: 6-78). The majority of patients presented with one or more symptoms of voiding dysfunction (95%), urinary incontinence (86%), irritative voiding symptoms (62%), dyspareunia (57%), recurrent urinary tract infections (UTIs) (29%), vaginal extrusion (20%) and erosion involving the urinary tract (5%). Patients had a mean of 2 prior anti-incontinence procedures (range 2-3). Over two-thirds had a combination of retropubic and transobturator MUS. Mean number of pre-operative investigations was 3.5 (1-6) including voiding cystourethrogram, cystoscopy and urodynamics. Two patients had complete remission, 14 partial remission, and five failed. Mean postoperative total UDI-6 and IIQ-7 scores at last clinic visit were 10 (range: 0-16/SD 4.1) and 11 (range: 0-28/SD 10.3), respectively. CONCLUSION: The management of women with suboptimal outcomes following two synthetic MUS from transvaginal excision results in modest symptomatic improvement but low permanent complete remission and frequent need for additional therapies.

Midurethral slings in the mesh litigation era.

Stress urinary incontinence (SUI) has always been a major health issue for women. With the progression of technology and surgical techniques, mid urethral slings (MUS) used in both transvaginal and transobturator routes have become the gold standard in the treatment of SUI. There is ample short to mid-term data confirming the efficacy and safety in using MUS in treating SUI in women. However, long-term data supporting the use of MUS in women to treat SUI is scarce. There has been much controversy surrounding the US Food and Drug Administrations' (FDA) public notification of potential complications surrounding the use of transvaginal mesh, which has been magnified and generalised by the media; but despite this there has still been substantial growth and uptake of MUS for treating SUI. In this review, we aim to explore some of the issues with MUS, the factors around litigation with mesh use, the impact of FDA's notification on the uptake of MUS and ultimately, the results and efficacy of MUS for the treatment of SUI.