Dataset Information

Two-Year Results of Burch Compared With Midurethral Sling With Sacrocolpopexy: A Randomized Controlled Trial.

ABSTRACT: 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.

SUBMITTER: Trabuco EC

PROVIDER: S-EPMC5740001 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Two-Year Results of Burch Compared With Midurethral Sling With Sacrocolpopexy: A Randomized Controlled Trial.

Trabuco Emanuel C EC Linder Brian J BJ Klingele Christopher J CJ Blandon Roberta E RE Occhino John A JA Weaver Amy L AL McGree Michaela E ME Gebhart John B JB

Obstetrics and gynecology 20180101 1

<h4>Objective</h4>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.<h4>Methods</h4>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 offic ...[more]

PMID: 29215517

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Project description: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.

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:ObjectiveTo evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence.MethodsFour-hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) compared with midurethral sling alone for mixed incontinence with 1-year follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective or objective failure or both. Subjective failure was defined as not meeting the minimal clinical important difference for improvement on the UDI (Urogenital Distress Inventory) total score (26.1 points). Objective failure was defined as not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for persistent urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated.ResultsOne hundred twelve of 379 (29.6%) women had overall treatment failure, with 56 of 379 (14.7%) undergoing additional treatment but only two needing intervention for stress incontinence. Previous overactive bladder (OAB) medication (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.96, 95% CI 1.17-3.31); detrusor overactivity on cystometrogram (OR 2.25, aOR 2.82, 95% CI 1.60-4.97); and higher volume at first urge (OR 1.03, aOR 1.04, 95% CI 1.01-1.07) were associated with overall failure. Worse UDI-urgency scores were associated with failure, with an added interaction effect in the midurethral sling-alone group.ConclusionsCertain clinical and urodynamic variables are associated with treatment failure after midurethral sling in women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. Overall, the need for additional urinary treatment was low and primarily for OAB.Clinical trial registrationClinicalTrials.gov, NCT01959347.

Project description:ObjectiveTo evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence.MethodsFour hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) against midurethral sling alone for mixed incontinence with 1 year of follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective failure, objective failure, or both. Subjective failure was defined as not meeting the minimal clinically important difference for improvement on the UDI (Urogenital Distress Inventory)-total score (26.1 points). Objective failure was not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated.ResultsPrevious overactive bladder medication use (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.89, 95% CI 1.10-3.25), detrusor overactivity on cystometrogram (OR 2.25, aOR 2.72, 95% CI 1.53-4.84), body mass index (OR 1.29, aOR 1.27, 95% CI 1.03-1.57), and Valsalva leak point pressure less than 60 cm H2O (OR 1.96, aOR 3.13, 95% CI 1.65-5.94) were associated with overall failure. Worse UDI urgency scores were associated with failure in the midurethral sling-alone group. Sling type (retropubic vs transobturator) was not associated with failure.ConclusionCertain clinical and urodynamic variables are associated with treatment failure after midurethral sling among women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. This information is helpful for counseling women with mixed incontinence who are considering surgery.Clinical trial registrationClinicalTrials.gov, NCT01959347.

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.

Dataset Information

Two-Year Results of Burch Compared With Midurethral Sling With Sacrocolpopexy: A Randomized Controlled Trial.

Publications

Two-Year Results of Burch Compared With Midurethral Sling With Sacrocolpopexy: A Randomized Controlled Trial.

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