Dataset Information

An in-house Composix™-based pubovaginal sling trial for female stress urinary incontinence: Five-year comparative followup to tension-free and transobturator vaginal tapes.

ABSTRACT: We compared the efficacy of three slings in the long-term treatment of stress urinary incontinence (SUI): tension-free vaginal tape (TVT), vaginal tape-obturator (TVT-O), and an in-house two-layered polypropylene mesh with a submicronic polytetrafluoroethylene (Composix™). Our primary endpoint was the objective measurement of continence (24-hour pad test). Secondarily, we measured the satisfaction and complication rates.This prospective, non-randomized study included 128 patients with SUI. Preoperative evaluation included medical history, physical exam, 24-hour pad test, Urinary Incontinence Quality of Life Scale (IQOL), FPSUND, and global satisfaction questionnaires. Patients were followed at one month postoperative, biannually for two years, and then annually for a total of five years. Followup visits included a focused questionnaire, physical exam, satisfaction questionnaire, 24-hour pad test, IQOL, and FPSUND questionnaires.Composix, TVT, and TVT-O groups included 60, 34, and 34 patients, respectively. No significant differences were found in baseline characteristics except for the pad test. Length of catheterization was the only immediate operative significant parameter (Composix 4.7 days vs. TVT 1.1 days vs. TVT-O 2.6 days; p=0.03). The entire cohort had significant improvements in their IQOL, FPSUND, and pad test at one and four years (p<0.01). The cohort-wide 24-hour pad test average weight was 30.4 g preoperatively vs. 5 g at 12 months (p<0.00001) (Composix 37 to 5 g, TVT 83 to 4 g, and TVT-O 55 to 5 g). The Composix group had a higher number of minor complications (Clavien I, II) and secondary procedures.This single-surgeon cohort with five-year followup demonstrated a large improvement and maintenance of continence in all three surgical groups. The Composix-based sling provided comparable continence outcomes at a fraction of the cost; however, its increased morbidity and higher complication rate raise concerns over future use.

SUBMITTER: Ben-Zvi T

PROVIDER: S-EPMC5542838 | biostudies-other | 2017 Aug

REPOSITORIES: biostudies-other

ACCESS DATA

Similar Datasets

Project description:ObjectivesTo evaluate long-term effects, complications and satisfaction among patients treated with AdVance™ and AdVance™ XP slings (AS) at a Norwegian specialist care hospital.Materials and methodsPatients who had an AS implanted due to stress urinary incontinence (SUI) 2009-2016 were identified retrospectively. Demographic and perioperative data were extracted from electronic patient files. We did a patient-reported outcome measure (PROM) survey with the Expanded Prostate Cancer Index Composite (EPIC-26) urinary domain and a Satisfaction Questionnaire (SQ) 2018-2020. Cure was defined as use of ≤1 pad/day.ResultsThe AS was implanted in 165 patients, mainly due to mild to moderate SUI (median leakage 112 g, range 13-589 g/24 h). Preoperative urodynamics showed mild detrusor overactivity (DO) in 11 patients. At 6-week follow-up, 148 patients (90%) were cured. The most common complication was urinary retention (N = 38), transient in 32 patients (range 1-42 days). Two patients were later operated with division of the sling due to persistent retention. During clinical follow-up of up to 12 years, 27 patients were reoperated due to persistent/recurrent incontinence. The PROM survey was sent to 125 patients and 115 (92%) replied at median 73 (20-134) months postoperatively. Ninety-one (79%) used ≤1 pads/day, 97 (85%) were satisfied, one patient-reported pain. Regression analyses showed that failure (>1 pad/day) was significantly associated with a higher amount of leakage preoperatively and at the 6-week follow-up. Total cure rate in the complete cohort was 64% at median 73 (20-134) months follow-up.ConclusionsThe AS shows good and persistent long-term results in patients with mild to moderate SUI. The only identified risk factor for long-term failure was higher amount of leakage preoperatively. The incidence of high body mass index (BMI), DO and previous radiotherapy was low and not significantly associated with failure but is still considered risk factors.

Project description:BackgroundWomen without stress urinary incontinence undergoing vaginal surgery for pelvic-organ prolapse are at risk for postoperative urinary incontinence. A midurethral sling may be placed at the time of prolapse repair to reduce this risk.MethodsWe performed a multicenter trial involving women without symptoms of stress incontinence and with anterior prolapse (of stage 2 or higher on a Pelvic Organ Prolapse Quantification system examination) who were planning to undergo vaginal prolapse surgery. Women were randomly assigned to receive either a midurethral sling or sham incisions during surgery. One primary end point was urinary incontinence or treatment for this condition at 3 months. The second primary end point was the presence of incontinence at 12 months, allowing for subsequent treatment for incontinence.ResultsOf the 337 women who underwent randomization, 327 (97%) completed follow-up at 1 year. At 3 months, the rate of urinary incontinence (or treatment) was 23.6% in the sling group and 49.4% in the sham group (P<0.001). At 12 months, urinary incontinence (allowing for subsequent treatment of incontinence) was present in 27.3% and 43.0% of patients in the sling and sham groups, respectively (P=0.002). The number needed to treat with a sling to prevent one case of urinary incontinence at 12 months was 6.3. The rate of bladder perforation was higher in the sling group than in the sham group (6.7% vs. 0%), as were rates of urinary tract infection (31.0% vs. 18.3%), major bleeding complications (3.1% vs. 0%), and incomplete bladder emptying 6 weeks after surgery (3.7% vs. 0%) (P≤0.05 for all comparisons).ConclusionsA prophylactic midurethral sling inserted during vaginal prolapse surgery resulted in a lower rate of urinary incontinence at 3 and 12 months but higher rates of adverse events. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health; OPUS ClinicalTrials.gov number, NCT00460434.).

Project description:ObjectiveTo identify factors that may contribute to patient satisfaction with outcome in women who received retropubic and transobturator midurethral slings.MethodsSatisfaction was assessed 12 months postsurgery as a planned analysis in 597 participants from a multicenter randomized trial comparing retropubic with transobturator midurethral slings using the Incontinence Surgery Satisfaction Questionnaire. Significantly related variables associated with satisfaction in univariable analyses were entered into multivariable logistic regression models to test their independent association with satisfaction.ResultsOne year after surgery, 264 (88.6%) in the retropubic group and 263 (88.0%) in the transobturator group completed satisfaction questionnaires. Both treatment groups demonstrated a high level of satisfaction with respect to urine leakage (retropubic 85.9% compared with transobturator 90.0%; P=.52), urgency to urinate, frequency of urination, capability of physical activity, social activity, ability to engage in sexual activity, and from an emotional standpoint. Baseline characteristics associated with reduced satisfaction were higher Medical, Epidemiologic, and Social Aspects of Aging Questionnaire urgency subscale scores, detrusor overactivity, and diabetes mellitus. The severity of both objective (frequency of incontinence episodes, pad test weight) and subjective (Incontinence Impact Questionnaire and Urogenital Distress Inventory score) measures of incontinence at baseline and the patients' perceptions of preoperative severity of incontinence and expectations of achieving postoperative cure or improvement were not statistically different between satisfied and unsatisfied patients. In the final multivariable model, satisfaction was associated with overall treatment success (odds ratio [OR] 2.57, 95% confidence interval [CI] 1.29-5.13], greater reduction in Urogenital Distress Inventory (OR 0.97, 95% CI 0.96-0.98) and Incontinence Impact Questionnaire scores (OR 0.99, 95% CI 0.98-0.99), and fewer complications (OR 0.55, 95% CI 0.30-0.99).ConclusionThe high level of satisfaction seen after midurethral sling procedures is associated with greater objective and patient-perceived improvement of stress incontinence and fewer complications.Clinical trial registrationClinicalTrials.gov, www.clinicaltrials.gov, NCT00325039.Level of evidenceII.

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.

Dataset Information

An in-house Composix™-based pubovaginal sling trial for female stress urinary incontinence: Five-year comparative followup to tension-free and transobturator vaginal tapes.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets