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NCT06953271 · ClinicalTrials.gov registry record · Phase 4
Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection
A Phase 4 study, sponsored by Women and Infants Hospital of Rhode Island.
- Not yet
- Registry status
- Phase 4
- Development phase
- 164
- Enrollment target
NCT06953271: Clinical Trial Phase 4 study, sponsored by Women and Infants Hospital of Rhode Island.
NCT06953271 is a Phase 4 study that has not yet begun recruiting, run by Women and Infants Hospital of Rhode Island. The registered enrollment target is 164 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06953271, a Phase 4 study, has not yet begun recruiting, sponsored by Women and Infants Hospital of Rhode Island.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 164 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to compare methenamine hippurate prophylaxis to routine antibiotic prophylaxis following onabotulinumtoxinA (BOTOX-A) injections in women with overactive bladder (OAB). Participants will be randomly selected to receive one of the two post-procedural prophylaxis medications. The primary outcome measure will be urinary tract infection (UTI) rates within 30 days from the BOTOX-A procedure. Secondary outcomes will assess patient satisfaction with the two post-procedural prophylaxis medications.
Primary Outcome
Presence of a urinary tract infection (UTI) within 30 days from intradetrusor BOTOX-A injection. UTI will be defined as positive lower urinary tract symptoms (dysuria, hematuria, and/or worsened urinary urgency or frequency) and a positive urine culture.
Interventions
- DRUG Methenamine Hippurate
- DRUG Typically prescribed oral antibiotic prophylaxis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2025-05-15 |
| Est. Completion | 2027-01-01 |
| Phase | Phase 4 |
What is known before NCT06953271 opens enrollment
NCT06953271 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Methenamine Hippurate is the first listed.
NCT06953271 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06953271 about?
NCT06953271 is a clinical study titled "Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection". The goal of this clinical trial is to compare methenamine hippurate prophylaxis to routine antibiotic prophylaxis following onabotulinumtoxinA (BOTOX-A) injections in women with overactive bladder (OAB). Participants will be randomly selected to receive one of the two post-procedural prophylaxis med...
What is the current status of trial NCT06953271?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 164 participants. The study started on 2025-05-15. Estimated completion is 2027-01-01.
What interventions are being tested in trial NCT06953271?
The interventions under investigation include: Methenamine Hippurate (DRUG), Typically prescribed oral antibiotic prophylaxis (DRUG).
Who is sponsoring clinical trial NCT06953271?
This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06953271's enrollment target sits among peer trials
164 496th of 2000 higher than 1,500 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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