Clinical trialNCT01959347CompletedPhase 3Interventional

Combined Treatment for Mixed Incontinence

SponsorNICHD Pelvic Floor Disorders NetworkEnrollment480Urinary Incontinence, StressUrinary Incontinence, Urge

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Dennis Wallace
RTI International
Principal Investigator
clinicaltrials.gov ↗
Vivian W. Sung
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama at Birmingham, Department of Obstetrics and Gynecology
Birmingham, Alabama, United States
Kaiser Permanente -- Downey
Downey, California, United States
University of California at San Diego, Ucsd Women'S Pelvic Medicine Center
La Jolla, California, United States
Kaiser Permanente -- San Diego
San Diego, California, United States
University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology
Albuquerque, New Mexico, United States
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, United States
Cleveland Clinic, Department Ob/gyn
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Magee-Womens Hospital, Department of Obstetrics and Gynecology
Pittsburgh, Pennsylvania, United States
Brown/ Women and Infants Hospital of Rhode Island, Center for Women'S Pelvic Medicine and Reconstructive Surgery
Providence, Rhode Island, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 28 Oct 2013
Primary completion: 9 Aug 2017
Completion: 29 Sept 2017
Last update posted: 14 May 2020
Registered enrollment: 480
Registry id: NCT01959347

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.