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NCT01959347 · ClinicalTrials.gov registry record · Phase 3
Combined Treatment for Mixed Incontinence
A Phase 3 study, sponsored by NICHD Pelvic Floor Disorders Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 480
- Enrollment target
NCT01959347: Completed Phase 3 study, sponsored by NICHD Pelvic Floor Disorders Network.
NCT01959347 is a Phase 3 study that has completed, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 480 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01959347, a Phase 3 study, has completed, sponsored by NICHD Pelvic Floor Disorders Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 480 participants
- Enrollment target
Study 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.
Primary Outcome
The Urogenital Distress Inventory (UDI) is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Interventions
- PROCEDURE Miduretheral Sling
- OTHER Miduretheral Sling with behavioral/pelvic floor therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 480 participants |
| Start Date | 2013-10-28 |
| Est. Completion | 2017-09-29 |
| Phase | Phase 3 |
What the finished NCT01959347 record still lists
NCT01959347 is an interventional study that assigns participants to a tested intervention. The registered 480 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Miduretheral Sling is the first listed.
NCT01959347 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01959347 about?
NCT01959347 is a clinical study titled "Combined Treatment for Mixed Incontinence". 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 comb...
What is the current status of trial NCT01959347?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 480 participants. The study started on 2013-10-28. Estimated completion is 2017-09-29.
What interventions are being tested in trial NCT01959347?
The interventions under investigation include: Miduretheral Sling (PROCEDURE), Miduretheral Sling with behavioral/pelvic floor therapy (OTHER).
Who is sponsoring clinical trial NCT01959347?
This trial is sponsored by NICHD Pelvic Floor Disorders Network, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01959347's enrollment target sits among peer trials
480 792nd of 2000 higher than 1,197 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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