Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 480 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01959347
The ClinicalTrials.gov registry entry for NCT01959347 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Pelvic Floor Disorders Network, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Miduretheral Sling is the first listed.
NCT01959347 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.