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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 is a Phase 3 study that has completed, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 386 participants.
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®.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01502956
The ClinicalTrials.gov registry entry for NCT01502956 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 386 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 InterStim® device is the first listed.
NCT01502956 reports 0 study locations.
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.
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