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Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection

Study acronym: META
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later May 1, 2026 → Jan 30, 2027
See other at-risk trials from Women and Infants Hospital of Rhode Island

Record History

  1. Primary completion pushed from May 1, 2026 to Jan 30, 2027v2 Show 4 more changesShow less
    • Recruitment opened
    • Study completion pushed from Jan 1, 2027 to Apr 1, 2027
    • Start date changed from estimate of May 15, 2025 to Aug 1, 2025
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06953271
Lead Sponsor Women and Infants Hospital of Rhode Island
Conditions
(from sponsor)		 Overactive Bladder (OAB), Urinary Tract Infection (Diagnosis)
Related terms Disease, Urinary Bladder, Overactive, Urinary Tract Infections
Enrollment 164 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov