Status:
NOT_YET_RECRUITING
Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection
Lead Sponsor:
Women and Infants Hospital of Rhode Island
Conditions:
Overactive Bladder (OAB)
Urinary Tract Infection (Diagnosis)
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 (OA...
Detailed Description
The purpose of this randomized controlled non-inferiority study is to determine if methenamine hippurate is non-inferior in regards to UTI rate when compared to routinely prescribed antibiotic prophyl...
Eligibility Criteria
Inclusion
- 18 years of age or older
- undergoing intradetrusor BOTOX-A injections in the office setting for overactive bladder
Exclusion
- cisgender male individuals
- neurogenic reasons for bladder symptoms (i.e. spinal cord injury, multiple sclerosis, etc.)
- known allergy and/or contraindication to methenamine hippurate
- currently already taking methenamine hippurate at the time of the procedure
- taking antibiotics for any reason on the day of their BOTOX-A procedure
- positive UTI at time of procedure (positive dip at time of procedure)
- history of bladder cancer
- history of pelvic radiation
- surgically altered detrusor muscle
- pre-procedural need for catheterization
- diagnosis of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
- pregnant or lactating individuals
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT06953271
Start Date
May 15 2025
End Date
January 1 2027
Last Update
May 1 2025
Active Locations (1)
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1
Women & Infants Hospital
Providence, Rhode Island, United States, 02903