At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 480 enrolled

Drug / intervention

Miduretheral Sling +1 moreprocedure

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01959347

NCT01959347Phase 3Completed

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Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence (ESTEEM)

NICHD Pelvic Floor Disorders Network·interventional·Posted Oct 10, 2013·Updated May 14, 2020

In Brief

A Phase 3 clinical trial evaluating Miduretheral Sling and Miduretheral Sling with behavioral/pelvic floor therapy for Urinary Incontinence, Stress and Urinary Incontinence, Urge. Completed, enrolled 480 participants across 10 sites.

Detailed Summary

The overarching goal of this randomized trial is to estimate the effect of combined midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared to MUS alone on successful treatment of MUI symptoms in 472 women. Secondary objectives include estimating the effect of combined treatment compared to MUS on improving overactive bladder (OAB) and stress urinary incontinence (SUI) outcomes separately, need for additional treatment, time to failure and identifying predictors of poor outcomes in this MUI population. A supplemental study, The Human Microbiome Study of ESTEEM, will evaluate the urinary and vaginal microbiome as it relates to women with MUI, their treatment and unaffected controls.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsUrinary Incontinence, Stress, Urinary Incontinence, Urge

CountriesUnited States

CollaboratorsWomen and Infants Hospital of Rhode Island, The Cleveland Clinic, Duke University, University of Alabama at Birmingham, University of New Mexico, University of Pennsylvania, University of Pittsburgh, University of California, San Diego, Kaiser Permanente, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), RTI International

Timeline

Phase 3CompletedFinished

2014201520162017201820192020202120222023202420252026

First PostedOct 2013

Enrollment StartOct 2013

Primary CompletionAug 2017

Study CompletionSep 2017

TodayJul 2026

First PostedOct 10, 2013

Enrollment StartOct 28, 2013

Primary CompletionAug 9, 2017

Study CompletionSep 29, 2017

TodayJul 2, 2026

Enrollment to primary: 3.8 yearsPosted 12.7 years ago

Interventions

Miduretheral Slingprocedure

MUS can include the TVT™ (mechanical cut mesh only, Gynecare, ETHICON Women's Health \& Urology, Somerville, NJ), TVT-O™ (mechanical cut mesh only, Gynecare), or Monarc™ (American Medical Systems, Minnetonka, MN).

Miduretheral Sling with behavioral/pelvic floor therapyother

MUS is combined with components of behavioral therapy (designed to change behaviors to encourage continence), and pelvic floor muscle therapy (designed to strengthen the pelvic floor muscles, enhance the physiological closure of the bladder neck, and improve coordination). This is done prior to MUS (1 visit) and after MUS for 5 visits at 2, 4, 6, 8 weeks and 6 months.