Methenamine Hippurate Compared to Typical Antibiotic Prophylaxis in the Prevention of Urinary Tract Infection Following Intradetrusor OnabotulinumtoxinA Injection for Treatment of Overactive Bladder: a Randomized Controlled Non-Inferiority Trial
Women and Infants Hospital of Rhode Island
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.
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 prophylaxis following intradetrusor BOTOX-A injections for women with OAB. As a secondary aim, this study will also compare patient medication satisfaction, as measured by the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General (FACIT-TS-G) for the two prophylactic medication arms. Comparators: Methenamine hippurate versus routinely prescribed antibiotic prophylaxis Methenami…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 18 years of age or older * undergoing intradetrusor BOTOX-A injections in the office setting for overactive bladder Exclusion Criteria: * 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…
Interventions
- DrugMethenamine Hippurate
Drug: Methenamine hippurate 1 gram by mouth twice daily for three days.
- DrugTypically prescribed oral antibiotic prophylaxis
Drug: typically prescribed oral antibiotic prophylaxis following intradetrusor BOTOX-A injections. This includes, but is not limited to, antibiotic medications such as nitrofurantoin, amoxicillin/clavulanic acid, and trimethoprim/sulfamethoxazole. Dosage will be determined per usual care. Duration of treatment will be standardized to three days.
Location
- Women & Infants HospitalProvidence, Rhode Island