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NCT00583219 · ClinicalTrials.gov registry record · Phase 1
Botulin-A Toxin Instillations and Overactive Bladder
A Phase 1 study of Overactive Bladder and Detrusor Hyperreflexia, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT00583219: Completed Phase 1 study of Overactive Bladder and Detrusor Hyperreflexia, sponsored by Mayo Clinic.
NCT00583219 is a Phase 1 study of Overactive Bladder and Detrusor Hyperreflexia that has completed, run by Mayo Clinic. The registered enrollment target is 25 participants, below the 207-participant average among 46 other Overactive Bladder trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00583219, a Phase 1 study of Overactive Bladder and Detrusor Hyperreflexia, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this pilot study is to evaluate the safety and efficacy of direct instillations of Botulinum-A toxin/DMSO into the bladder via a catheter system as a means of treating women with symptoms of overactive bladder and secondary urinary incontinence. In doing so, we will focus on estimating the percentage of women who experience an improvement in their urinary incontinence symptoms at one month and three months following this novel instillation technique.
Primary Outcome
The study coordinator instructed the subject to keep record of any incontinence episodes during the 24-hour period prior to their baseline and follow-up visits.
Conditions Studied
Interventions
- DRUG Botulinum-A toxin
- DRUG Dimethyl sulfoxide (DMSO)
Study Locations (1)
Florida
- Mayo Clinic Jacksonville - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2006-03 |
| Est. Completion | 2008-05 |
| Phase | Phase 1 |
What the finished NCT00583219 record still lists
NCT00583219 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 207-participant average among 46 other Overactive Bladder trials with a reported enrollment target (88% lower).
The record links to 3 conditions, with Overactive Bladder appearing as the primary indexed condition, and to 2 interventions - of which Botulinum-A toxin is the first listed.
NCT00583219 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT00583219 about?
NCT00583219 is a clinical study titled "Botulin-A Toxin Instillations and Overactive Bladder". The primary objective of this pilot study is to evaluate the safety and efficacy of direct instillations of Botulinum-A toxin/DMSO into the bladder via a catheter system as a means of treating women with symptoms of overactive bladder and secondary urinary incontinence. In doing so, we will focus on...
What is the current status of trial NCT00583219?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2006-03. Estimated completion is 2008-05.
What conditions does trial NCT00583219 study?
This clinical trial studies the following conditions: Overactive Bladder, Detrusor Hyperreflexia, Detrusor Instability.
What interventions are being tested in trial NCT00583219?
The interventions under investigation include: Botulinum-A toxin (DRUG), Dimethyl sulfoxide (DMSO) (DRUG).
Who is sponsoring clinical trial NCT00583219?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00583219 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Overactive Bladder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00583219's enrollment target sits among peer trials
25 38th of 46 higher than 9 of 46 other Overactive Bladder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Overactive Bladder 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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