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NCT05463822 · ClinicalTrials.gov registry record · Early Phase 1
Transvaginal Botulinum Toxin A Chemodenervation for Overactive Bladder
A Early Phase 1 study, sponsored by Stanford University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
NCT05463822: Completed Early Phase 1 study, sponsored by Stanford University.
NCT05463822 is a Early Phase 1 study that has completed, run by Stanford University. The registered enrollment target is 15 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05463822, a Early Phase 1 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
Overactive bladder (OAB) is a highly prevalent disease process that, when refractory to oral medication therapy, can be effectively managed with injection of botulinum toxin A (BTA) into the detrusor muscle of the bladder. However, the traditional procedure requires a cystoscope inserted into the bladder which can be painful and is associated with a risk of urinary tract infection. The purpose of this study is to determine if transvaginal injection of BTA into the detrusor muscle of the bladder wall is feasible to perform, and efficacious for the treatment of refractory overactive bladder.
Primary Outcome
Assessing improvement in urinary symptoms following intervention. The Treatment Benefit Scale Questionnaire asks patients to state if their condition (overactive bladder) has 1) greatly improved, 2) improved, 3) not changed, or 4) worsened during treatment. Patients who select 1 or 2 are considered to have derived a perceived benefit from the treatment, and will represent those patients who had a positive TBS response.
Interventions
- DRUG Transvaginal botulinum toxin A (BTA) injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-06-20 |
| Est. Completion | 2021-09-27 |
| Phase | Early Phase 1 |
What the finished NCT05463822 record still lists
NCT05463822 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Transvaginal botulinum toxin A (BTA) injection is the first listed.
NCT05463822 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05463822 about?
NCT05463822 is a clinical study titled "Transvaginal Botulinum Toxin A Chemodenervation for Overactive Bladder". Overactive bladder (OAB) is a highly prevalent disease process that, when refractory to oral medication therapy, can be effectively managed with injection of botulinum toxin A (BTA) into the detrusor muscle of the bladder. However, the traditional procedure requires a cystoscope inserted into the bl...
What is the current status of trial NCT05463822?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2019-06-20. Estimated completion is 2021-09-27.
What interventions are being tested in trial NCT05463822?
The interventions under investigation include: Transvaginal botulinum toxin A (BTA) injection (DRUG).
Who is sponsoring clinical trial NCT05463822?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05463822's enrollment target sits among peer trials
15 1404th of 2000 higher than 527 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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