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Two Intraoperative Techniques for Midurethral Sling Tensioning: A Randomized Controlled Trial.

ABSTRACT: OBJECTIVE:To evaluate whether the use of a Mayo Scissor as a suburethral spacer compared with a Babcock clamp holding a loop of tape under the urethra results in different rates of abnormal bladder outcomes 12 months after retropubic midurethral sling surgery. METHODS:The MUST (Mid-Urethral Sling Tensioning) trial was a block-randomized, double-blind, multicenter clinical trial that allocated women to have their retropubic midurethral slings tensioned by Scissor or Babcock technique. The primary outcome (abnormal bladder) was a composite of persistent stress urinary incontinence (SUI), overactive bladder, and urinary retention. Secondary outcomes included outcomes of the composite, postoperative catheterization, incontinence-related questionnaires, repeat incontinence treatment, and uroflowmetry. Sample size of 159 in each arm (N=318) was planned for a superiority trial, hypothesizing a 10% difference in primary outcome. RESULTS:From September 2015 to December 2017, 506 women were screened and 318 were randomized. Baseline characteristics were similar in each arm. At 12 months, 253 (79.6%) women provided information on primary outcome: 40 of 128 (31.3%) patients with midurethral slings tensioned by Scissor experienced abnormal bladder, compared with 23 of 125 (18.4%) of those with midurethral slings tensioned by Babcock (P=.018, relative difference 12.9%). Secondary analyses favored Babcock for median duration of catheterization and the proportions of women experiencing urinary retention requiring sling lysis. Uroflowmetry parameters suggest the Scissor technique is more restrictive. Rates of mesh erosion were lower for the Scissor arm. No differences occurred in proportions of women experiencing patient reported persistent SUI after surgery. CONCLUSION:Abnormal bladder outcomes were 12.9% less frequent for women with midurethral slings tensioned by Babcock. Both techniques provided a comparable patient reported cure for SUI at 12 months. Women with midurethral slings tensioned by Scissors experienced more intervention for obstruction, whereas those with midurethral slings tensioned by Babcock experienced higher rates of mesh erosion. This information about how the postoperative courses differ allows surgeons to better counsel patients preoperatively or tailor their choice of technique. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, NCT02480231. FUNDING SOURCE:Boston Scientific.

SUBMITTER: Brennand EA

PROVIDER: S-EPMC7431154 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Two Intraoperative Techniques for Midurethral Sling Tensioning: A Randomized Controlled Trial.

Brennand Erin A EA Wu Guosong G Houlihan Sara S Globerman Dobrochna D Gagnon Louise-Helene LH Birch Colin C Hyakutake Momoe M Carlson Kevin V KV Al-Shankiti Hanan H Robert Magali M Lazare Darren D Kim-Fine Shunaha S

Obstetrics and gynecology 20200901 3

<h4>Objective</h4>To evaluate whether the use of a Mayo Scissor as a suburethral spacer compared with a Babcock clamp holding a loop of tape under the urethra results in different rates of abnormal bladder outcomes 12 months after retropubic midurethral sling surgery.<h4>Methods</h4>The MUST (Mid-Urethral Sling Tensioning) trial was a block-randomized, double-blind, multicenter clinical trial that allocated women to have their retropubic midurethral slings tensioned by Scissor or Babcock techniq ...[more]

PMID: 32769657

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Project description:OBJECTIVE:To evaluate 1- and 2-year urinary continence rates after Burch retropubic urethropexy compared with a retropubic midurethral sling for women with urinary incontinence undergoing sacrocolpopexy. METHODS:We conducted a planned secondary analysis of a multicenter, randomized, single-blind trial comparing Burch with a sling that enrolled participants from June 2009 to August 2013. Objective outcome measures of continence were assessed at 1- and 2-year follow-up through office visits and validated questionnaires. Overall continence was defined as a negative stress test, no retreatment for stress incontinence, and no self-reported urinary incontinence (International Consultation on Incontinence Questionnaire, Short Form, score, 0). Stress-specific continence was defined as fulfillment of the first two criteria and no self-reported stress-related incontinence. Primary outcomes were assessed with intention-to-treat and within-protocol analyses. Comparisons between groups were evaluated using ? or Fisher exact test. RESULTS:The two groups were similar in all measured baseline features. Outcome assessments at 2 years were available for 48 of 57 patients (84%) in the sling group and 45 of 56 patients (80%) in the Burch group. With intention-to-treat analysis, the sling group had significantly higher rates of overall continence than the Burch group (49% [28/57] vs 29% [16/56]; 95% CI for absolute risk difference 3.0-38.1; P=.03) at 1- but not 2-year follow-up (47% [27/57] vs 32% [18/56]; 95% CI for absolute risk difference -2.6 to 33.1; P=.10). The sling group had significantly higher rates of stress-specific continence than the Burch group at 1-year (70% [40/57] vs 46% [26/56]; 95% CI for absolute risk difference 6.1-41.4; P=.01) and 2-year (70% [40/57] vs 45% [25/56]; 95% CI for absolute risk difference 7.9-43.2; P=.006) follow-up. No difference was detected in prolapse recurrence, voiding dysfunction, antimuscarinic medication use, urgency incontinence, or patient satisfaction. CONCLUSION:Among women with baseline urinary incontinence undergoing sacrocolpopexy, the retropubic midurethral sling resulted in higher stress-specific continence rates than Burch retropubic urethropexy at 1- and 2-year follow-up.

Project description:Postoperative opioid prescribing has historically lacked information critical to balancing the pain control needs of the individual patient with our professional responsibility to judiciously prescribe these high-risk medications. This data evaluates pain control, satisfaction with pain control, and opioid utilization among patients undergoing isolated mid-urethral sling (MUS) randomized to one of two different opioid prescribing regimens. This study was registered on clinicaltrials.gov (NCT04277975). Women undergoing isolated MUS by a Female Pelvic Medicine and Reconstructive Surgery physician at a Penn State Health hospital from June 1, 2020 to November 22, 2021 were offered enrollment into this prospective, randomized, open-label, non-inferiority clinical trial. Participants gave informed consent and were enrolled by a member of the study team. Allocation was concealed to patient and study personnel until randomization on the day of surgery. Preoperatively, all participants completed baseline demographic and pain surveys including CSI-9, PCS, and Likert pain score (scale 0-10). Participants were randomized to either receive a standard prescription of ten 5 mg tablets oxycodone provided preoperatively (standard) or opioid prescription provided only upon patient request postoperatively (restricted). Randomization was performed by the study team surgeon using the REDCap randomization module on the day of surgery. Following MUS, subjects completed a daily diary for 1 week, i.e., postoperative day (POD) 0 through 7. Within the dairy, subjects provided the following information: average daily pain score, opioid use and amount of opioid utilized, other forms of pain management, satisfaction with pain control, perception of the amount of opioid prescribed, and need for pain management hospital/clinic visits. The online Prescription Drug Monitoring Program (PDMP) was queried for all patients to determine if prescriptions for opioids were filled during the postoperative period. The primary outcome was average postoperative day 1 pain score and an a priori determined margin of non-inferiority was set at 2 points. Secondary outcomes included whether subject filled an opioid prescription (indicated by the online PDMP), opioid use (yes/no), satisfaction with pain control (on a scale of 1= "much worse" to 5= "much better" than expected), and how subjects felt about the amount of opioid prescribed (on a scale of 1="prescribed far more" to 3="prescribed the right amount" to 5="prescribed far less" opioid than needed). 82 participants underwent isolated MUS placement and met inclusion criteria; 40 were randomized to the standard arm and 42 to the restricted group. Within this manuscript, we detail the data obtained from this randomized clinical trial and the methods utilized.

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: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 clinical and demographic factors predictive of midurethral sling failure.MethodsOverall treatment failure was defined by one or more of the following objective outcomes: a positive stress test, positive 24-hour pad test or retreatment for stress urinary incontinence (SUI); subjective outcomes: self reported SUI by the Medical, Epidemiologic and Social Aspect of Aging questionnaire, incontinent episodes by 3-day diary, or retreatment for SUI, or a combination of these. Logistic regression models adjusting for sling type and clinical site were used to predict odds of overall treatment failure after univariable analysis. Models were also fit to compare factors associated with objective failure and subjective failure only.ResultsPrevious UI surgery (odds ratio [OR] 1.99, 95% confidence interval [CI] 1.14-3.47); maximum Q-tip excursion<30° (OR 1.89, 95% CI 1.16-3.05); Medical, Epidemiologic and Social Aspect of Aging questionnaire urge score per 10 points (OR 1.97, 95% CI 1.21-3.21); and pad weight per 10 g (OR 1.06, 95% CI 1.02-1.10) were predictors of overall failure. Having concomitant surgery (OR 0.44, 95% CI 0.22-0.90) was predictive of subjective failure only rather than objective failure. Age per 10 years (OR 1.48, 95% CI 1.14-1.90); Urogenital Distress Inventory score per 10 points (OR 1.09, 95% CI 1.02-1.17); pad weight per 10 g (OR 1.05, 95% CI 1.01-1.10) were predictive of objective failure compared with subjective failure only. Associations of risk factors and failure were similar independent of sling type (retropubic or transobturator).ConclusionTwelve months after surgery, risk factors for overall and objective treatment failure were similar in women undergoing retropubic and transobturator sling procedures. This information may assist in counseling patients regarding efficacy of sling procedures and in setting expectations for women at increased odds for treatment failure.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.

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Two Intraoperative Techniques for Midurethral Sling Tensioning: A Randomized Controlled Trial.

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Two Intraoperative Techniques for Midurethral Sling Tensioning: A Randomized Controlled Trial.

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