Dataset Information

Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women.

ABSTRACT: Complications of surgical mesh procedures have led to legal cases against manufacturers worldwide and to national inquiries about their safety. The aim of this study was to investigate the rate of adverse events of these procedures for stress urinary incontinence in England over 8 years. This was a retrospective cohort study of first-time tension-free vaginal tape (TVT), trans-obturator tape (TOT) or suprapubic sling (SS) surgical mesh procedures between April 2007 and March 2015. Cases were identified from the Hospital Episode Statistics database. Outcomes included number and type of procedures, including those potentially confounded by concomitant procedures, and frequency, nature and timing of complications. 92,246 first-time surgical mesh procedures (56,648 TVT, 34,704 TOT, 834 SS and 60 combinations) were identified, including 68,002 unconfounded procedures. Peri-procedural and 30-day complication rates in the unconfounded cohort were 2.4 [2.3-2.5]% and 1.7 [1.6-1.8]% respectively; 5.9 [5.7-6.1]% were readmitted at least once within 5 years for further mesh intervention or symptoms of complications, the highest risk being within the first 2 years. Complication rates were higher in the potentially confounded cohort. The complication rate within 5 years of the mesh procedure was 9.8 [9.6:10.0]% This evidence can inform future decision-making on this procedure.

SUBMITTER: Keltie K

PROVIDER: S-EPMC5607307 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women.

Keltie Kim K Elneil Sohier S Monga Ashwani A Patrick Hannah H Powell John J Campbell Bruce B Sims Andrew J AJ

Scientific reports 20170920 1

Complications of surgical mesh procedures have led to legal cases against manufacturers worldwide and to national inquiries about their safety. The aim of this study was to investigate the rate of adverse events of these procedures for stress urinary incontinence in England over 8 years. This was a retrospective cohort study of first-time tension-free vaginal tape (TVT), trans-obturator tape (TOT) or suprapubic sling (SS) surgical mesh procedures between April 2007 and March 2015. Cases were ide ...[more]

PMID: 28931856

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Project description:Importance:There is concern about outcomes of midurethral mesh sling insertion for women with stress urinary incontinence. However, there is little evidence on long-term outcomes. Objective:To examine long-term mesh removal and reoperation rates in women who had a midurethral mesh sling insertion for stress urinary incontinence. Design, Setting, and Participants:This population-based retrospective cohort study included 95 057 women aged 18 years or older who had a first-ever midurethral mesh sling insertion for stress urinary incontinence in the National Health Service hospitals in England between April 1, 2006, and December 31, 2015. Women were followed up until April 1, 2016. Exposures:Patient and hospital factors and retropubic or transobturator mesh sling insertions. Main Outcomes and Measures:The primary outcome was the risk of midurethral mesh sling removal (partial or total) and secondary outcomes were reoperation for stress urinary incontinence and any reoperation including mesh removal, calculated with death as competing risk. A multivariable Fine-Gray model was used to calculate subdistribution hazard ratios as estimates of relative risk. Results:The study population consisted of 95 057 women (median age, 51 years; interquartile range, 44-61 years) with first midurethral mesh sling insertion, including 60 194 with retropubic insertion and 34 863 with transobturator insertion. The median follow-up time was 5.5 years (interquartile range, 3.2-7.5 years). The rate of midurethral mesh sling removal was 1.4% (95% CI, 1.3%-1.4%) at 1 year, 2.7% (95% CI, 2.6%-2.8%) at 5 years, and 3.3% (95% CI, 3.2%-3.4%) at 9 years. Risk of removal declined with age. The 9-year removal risk after transobturator insertion (2.7% [95% CI, 2.4%-2.9%]) was lower than the risk after retropubic insertion (3.6% [95% CI, 3.5%-3.8%]; subdistribution hazard ratio, 0.72 [95% CI, 0.62-0.84]). The rate of reoperation for stress urinary incontinence was 1.3% (95% CI, 1.3%-1.4%) at 1 year, 3.5% (95% CI, 3.4%-3.6%) at 5 years, and 4.5% (95% CI, 4.3%-4.7%) at 9 years. The rate of any reoperation, including mesh removal, was 2.6% (95% CI, 2.5%-2.7%) at 1 year, 5.5% (95% CI, 5.4%-5.7%) at 5 years, and 6.9% (95% CI, 6.7%-7.1%) at 9 years. Conclusions and Relevance:Among women undergoing midurethral mesh sling insertion, the rate of mesh sling removal at 9 years was estimated as 3.3%. These findings may guide women and their surgeons when making decisions about surgical treatment of stress urinary incontinence.

Project description:BACKGROUND:Women with refractory urgency urinary incontinence (ie, unresponsive to behavioral and pharmacological interventions) are treated with onabotulinumtoxinA or sacral neuromodulation. OBJECTIVE:The objective of the study was to compare treatment efficacy and adverse events in women <65 and ?65 years old treated with onabotulinumtoxinA or sacral neuromodulation. STUDY DESIGN:This study was a planned secondary analysis of a multicenter, randomized trial that enrolled community-dwelling women with refractory urgency urinary incontinence to onabotulinumtoxinA or sacral neuromodulation treatments. The primary outcome was a change in mean daily urgency urinary incontinence episodes on a bladder diary over 6 months. Secondary outcomes included ?75% urgency urinary incontinence episode reduction, change in symptom severity/quality of life, treatment satisfaction, and treatment-related adverse events. RESULTS:Both age groups experienced improvement in mean urgency urinary incontinence episodes per day following each treatment. There was no evidence that mean daily urgency urinary incontinence episode reduction differed between age groups for onabotulinumtoxinA (adjusted coefficient, -0.127, 95% confidence interval, -1.233 to 0.979; P = .821) or sacral neuromodulation (adjusted coefficient, -0.698, 95% confidence interval, -1.832 to 0.437; P = .227). Among those treated with onabotulinumtoxinA, women <65 years had 3.3-fold greater odds of ?75% resolution than women ?65 years (95% confidence interval, 1.56 -7.02). Women <65 years had a greater reduction in Overactive Bladder Questionnaire Short Form symptom bother scores compared with women ?65 years by 7.49 points (95% confidence interval, -3.23 to -11.74), regardless of treatment group. There was no difference between quality of life improvement by age. Women ?65 years had more urinary tract infections following onabotulinumtoxinA and sacral neuromodulation (odds ratio, 1.9, 95% confidence interval, 1.2-3.3). There was no evidence of age differences in sacral neuromodulation revision/removal or catheterization following onabotulinumtoxinA treatment. CONCLUSION:Younger women experienced greater absolute continence, symptom improvement, and fewer urinary tract infections; both older and younger women had beneficial urgency urinary incontinence episode reduction, similar rates of other treatment adverse events, and improved quality of life.

Project description:BACKGROUND:Little is known about short- and long-term pain and functional activity after surgery for pelvic organ prolapse. OBJECTIVE:The objectives of the study were to describe postoperative pain and functional activity after transvaginal native tissue reconstructive surgery with apical suspension and retropubic synthetic midurethral sling and to compare these outcomes between patients receiving 2 common transvaginal prolapse repairs, uterosacral ligament, and sacrospinous ligament vaginal vault suspension. STUDY DESIGN:This planned secondary analysis of a 2 × 2 factorial randomized trial included 374 women randomized to receive uterosacral (n = 188) or sacrospinous (n = 186) vaginal vault suspension to treat both stages 2-4 apical vaginal prolapse and stress urinary incontinence between 2008 and 2013 at 9 medical centers. Participants were also randomized to receive perioperative pelvic muscle therapy or usual care. All patients received transvaginal native tissue repairs and a midurethral sling. Participants completed the Surgical Pain Scales (0-10 numeric rating scales; higher scores = greater pain) and Activity Assessment Scale (0-100; higher score = higher activity) prior to surgery and at 2 weeks, 4-6 weeks, and 3 months postoperatively. The MOS 36-item Short-Form Health Survey was completed at baseline and 6, 12, and 24 months after surgery; the bodily pain, physical functioning, and role-physical subscales were used for this analysis (higher scores = less disability). Self-reported pain medication use was also collected. RESULTS:Before surgery, average pain at rest and during normal activity were (adjusted mean ± SE) 2.24 ± 0.23 and 2.76 ± 0.25; both increased slightly from baseline at 2 weeks (+0.65, P = .004, and +0.74, P = .007, respectively) and then decreased below baseline at 3 months (-0.87 and -1.14, respectively, P < .001), with no differences between surgical groups. Pain during exercise/strenuous activity and worst pain decreased below baseline levels at 4-6 weeks (-1.26, P = .014, and -0.95, P = .002) and 3 months (-1.97 and -1.50, P < .001) without differences between surgical groups. Functional activity as measured by the Activity Assessment Scale improved from baseline at 4-6 weeks (+9.24, P < .001) and 3 months (+13.79, P < .001). The MOS 36-item Short-Form Health Survey Bodily Pain, Physical Functioning, and Role-Physical Scales demonstrated significant improvements from baseline at 6, 12, and 24 months (24 months: +5.62, +5.79, and +4.72, respectively, P < .001 for each) with no differences between groups. Use of narcotic pain medications was reported by 14.3% of participants prior to surgery and 53.7% at 2 and 26.1% at 4-6 weeks postoperatively; thereafter use was similar to baseline rates until 24 months when it decreased to 6.8%. Use of nonnarcotic pain medication was reported by 48.1% of participants prior to surgery, 68.7% at 2 weeks, and similar to baseline at 3 months; thereafter use dropped steadily to 26.6% at 2 years. Uterosacral ligament suspension resulted in less new or worsening buttock pain than sacrospinous suspension at 4-6 weeks postoperatively (4.6% vs 10.5%, P = .043) but no difference in groin or thigh pain. CONCLUSION:Pain and functional activity improve for up to 2 years after native tissue reconstructive surgery with uterosacral or sacrospinous vaginal vault suspension and midurethral sling for stages 2-4 pelvic organ prolapse. On average, immediate postoperative pain is low and improves to below baseline levels by 4-6 weeks.

Dataset Information

Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women.

Publications

Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women.

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