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NCT04401176 · ClinicalTrials.gov registry record · Phase 2
Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain Syndrome
A Phase 2 study, sponsored by Walter Reed National Military Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
NCT04401176: Completed Phase 2 study, sponsored by Walter Reed National Military Medical Center.
NCT04401176 is a Phase 2 study that has completed, run by Walter Reed National Military Medical Center. The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04401176, a Phase 2 study, has completed, sponsored by Walter Reed National Military Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
Study Summary
Recognition of interstitial cystitis (IC)/bladder pain syndrome (BPS) is increasing. There is a dire need to develop effective treatment options for these patients as it manifests as more than a physical disease, affecting general and psychological health as well. Existing trials comparing varying bladder instillation formulations have not identified an optimal bladder instillation therapy, however existing studies support combined heparin and alkalinized lidocaine bladder instillation as an affordable and effective treatment for IC/BPS. Additionally, intradetrusor onabotulinumtoxinA injection has been well established for the treatment of overactive bladder (OAB), a constellation of symptoms similar to that of IC/BPS. OnabotulinumtoxinA has now come into the forefront for treatment of OAB due to its efficacy, safety profile, and absence of cognitive effects related to the previous mainstay anticholinergic treatment. While both bladder instillation and onabotulinumtoxinA therapy have been shown to be effective for treatment of IC/BPS, a direct comparison of these treatments has not been performed. We therefore designed a randomized controlled trial to compare the efficacy of heparin with alkalized local anesthetic bladder instillation versus intradetrusor onabotulinumtoxinA injection in treating IC/BPS symptoms.
Primary Outcome
Consists of O'Leary-Sant Symptom and Problem Index, total score 0-36.
Interventions
- DRUG Onabotulinum Toxin A
- DRUG Heparin & Alkalinized Lidocaine Bladder Instillation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2020-09-15 |
| Est. Completion | 2023-06-01 |
| Phase | Phase 2 |
What the finished NCT04401176 record still lists
NCT04401176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 2 interventions - of which Onabotulinum Toxin A is the first listed.
NCT04401176 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04401176 about?
NCT04401176 is a clinical study titled "Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain Syndrome". Recognition of interstitial cystitis (IC)/bladder pain syndrome (BPS) is increasing. There is a dire need to develop effective treatment options for these patients as it manifests as more than a physical disease, affecting general and psychological health as well. Existing trials comparing varying b...
What is the current status of trial NCT04401176?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2020-09-15. Estimated completion is 2023-06-01.
What interventions are being tested in trial NCT04401176?
The interventions under investigation include: Onabotulinum Toxin A (DRUG), Heparin & Alkalinized Lidocaine Bladder Instillation (DRUG).
Who is sponsoring clinical trial NCT04401176?
This trial is sponsored by Walter Reed National Military Medical Center, which has 48 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04401176's enrollment target sits among peer trials
58 1135th of 2000 higher than 860 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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