Combined Treatment for Mixed Incontinence
Public ClinicalTrials.gov record NCT01959347. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence (ESTEEM)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01959347
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 480 participants
Conditions and interventions
Interventions
Procedure · Other
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 27, 2013
- Primary completion
- Aug 8, 2017
- Completion
- Sep 28, 2017
- Last update posted
- May 13, 2020
2013 – 2017
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham, Department of Obstetrics and Gynecology | Birmingham | Alabama | 35249-7333 | — |
| Kaiser Permanente -- Downey | Downey | California | 90242 | — |
| University of California at San Diego, UCSD Women's Pelvic Medicine Center | La Jolla | California | 92037-0974 | — |
| Kaiser Permanente -- San Diego | San Diego | California | 92110 | — |
| University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology | Albuquerque | New Mexico | 87131-0001 | — |
| Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery | Durham | North Carolina | 27707 | — |
| Cleveland Clinic, Department OB/GYN | Cleveland | Ohio | 44195 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Magee-Womens Hospital, Department of Obstetrics and Gynecology | Pittsburgh | Pennsylvania | 15213 | — |
| Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery | Providence | Rhode Island | 02903 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01959347, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 13, 2020 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01959347 live on ClinicalTrials.gov.