Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection
Starting soon · Phase 4
Conditions studied: Overactive Bladder (OAB), Urinary Tract Infection (Diagnosis)
In brief
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.
Key facts
- Study ID
- NCT06953271
- Run by
- Women and Infants Hospital of Rhode Island
- People needed
- 164
- Starts
- 2025-05-15
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2025-05-01
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 18 years of age or older
- undergoing intradetrusor BOTOX-A injections in the office setting for overactive bladder
You may not qualify if…
- 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
Where it is running
- Women & Infants Hospital — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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