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NCT01502956 · ClinicalTrials.gov registry record · Phase 3
Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA)
A Phase 3 study, sponsored by NICHD Pelvic Floor Disorders Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 386
- Enrollment target
NCT01502956: Completed Phase 3 study, sponsored by NICHD Pelvic Floor Disorders Network.
NCT01502956 is a Phase 3 study that has completed, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 386 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01502956, a Phase 3 study, has completed, sponsored by NICHD Pelvic Floor Disorders Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 386 participants
- Enrollment target
Study Summary
The purpose of this randomized, open-label, active-control trial is to compare the effectiveness of intra-detrusor botulinum toxin A (Botox A®, Allergan) versus sacral neuromodulation (InterStim®, Medtronic) for the treatment of refractory urge urinary incontinence. In addition, the study will evaluate select technical attributes of the interventions as well as the effect of these two interventions on other lower urinary tract and pelvic floor symptoms. Hypothesis: InterStim® therapy will result in a greater reduction in daily urge urinary incontinence episodes over the 6-month follow-up period as compared to Botox A® injection. A supplemental study investigates whether biological markers including those related to inflammation and connective tissue remodeling change following treatments with Botox A® and Interstim®.
Primary Outcome
The primary outcome is the change from baseline in mean number of UUI episodes over the first 6-month visit period (1, 2, 3, 4, 5 and 6 month assessments); and is measured using 3-day bladder diaries administered monthly for the first 6 month visit period.
Interventions
- DEVICE InterStim® device
- DRUG Botox® injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 386 participants |
| Start Date | 2012-02 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
What the finished NCT01502956 record still lists
NCT01502956 is an interventional study that assigns participants to a tested intervention. The registered 386 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 (50% lower).
The record links to 0 conditions, and to 2 interventions - of which InterStim® device is the first listed.
NCT01502956 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01502956 about?
NCT01502956 is a clinical study titled "Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA)". The purpose of this randomized, open-label, active-control trial is to compare the effectiveness of intra-detrusor botulinum toxin A (Botox A®, Allergan) versus sacral neuromodulation (InterStim®, Medtronic) for the treatment of refractory urge urinary incontinence. In addition, the study will evalu...
What is the current status of trial NCT01502956?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 386 participants. The study started on 2012-02. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01502956?
The interventions under investigation include: InterStim® device (DEVICE), Botox® injection (DRUG).
Who is sponsoring clinical trial NCT01502956?
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 NCT01502956's enrollment target sits among peer trials
386 973rd of 2000 higher than 1,026 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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