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NCT00373789 · ClinicalTrials.gov registry record · Phase 3
Refractory Urge Incontinence and Botox Injections
A Phase 3 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Terminated
- Registry status
- Phase 3
- Development phase
- 87
- Enrollment target
NCT00373789: Clinical Trial Phase 3 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00373789 is a Phase 3 study that was terminated before completion, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 87 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00373789, a Phase 3 study, was terminated before completion, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 87 participants
- Enrollment target
Study Summary
The purpose of this study is to see whether Botox A (injected into the bladder muscle) can improve symptoms of urge incontinence that has not improved with usual medical treatments.
Primary Outcome
To allow sufficient time for the onset of action of botulinum toxin A, the earliest outcome measurement was 60 days after injection. Failure was defined as a patient global impression of improvement (PGI-I) score of 4 or greater, the commencement of any new treatment at any time after the first injection or increased intensity of previously established treatment for DOI.
Interventions
- DRUG Botulinum Toxin A, bladder detrusor muscle injection
- DRUG Vehicle saline as placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2006-06 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
Why NCT00373789 stopped before completion
NCT00373789 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Botulinum Toxin A, bladder detrusor muscle injection is the first listed.
NCT00373789 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00373789 about?
NCT00373789 is a clinical study titled "Refractory Urge Incontinence and Botox Injections". The purpose of this study is to see whether Botox A (injected into the bladder muscle) can improve symptoms of urge incontinence that has not improved with usual medical treatments.
What is the current status of trial NCT00373789?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 87 participants. The study started on 2006-06. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00373789?
The interventions under investigation include: Botulinum Toxin A, bladder detrusor muscle injection (DRUG), Vehicle saline as placebo (DRUG).
Who is sponsoring clinical trial NCT00373789?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00373789's enrollment target sits among peer trials
87 1742nd of 2000 higher than 256 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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