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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 18 years of age or older
• undergoing intradetrusor BOTOX-A injections in the office setting for overactive bladder
Locations
United States
Rhode Island
Women & Infants Hospital
RECRUITING
Providence
Contact Information
Primary
Colin Russell, MD, MPH
CoRussell@wihri.org
401-453-7560
Backup
Kyle Wohlrab, MD
KWohlrab@CareNE.org
401-453-7560
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 164
Treatments
Active_comparator: Typically prescribed oral antibiotic prophylaxis
Typically prescribed oral antibiotic prophylaxis for the purposes of this study is defined as oral antibiotics that are routinely prescribed following BOTOX-A injections for UTI prophylaxis. Given known heterogeneity in antibiotic prophylaxis type and duration as well as the lack of standardized antibiotic recommendations for intradetrusor BOTOX-A injections, the choice of antibiotic prophylaxis is deferred to the physician performing the BOTOX-A injections. The duration of treatment will be standardized to three days, based off previous studies.
Experimental: Methenamine hippurate prophylaxis
Participants in the experimental arm will receive methenamine hippurate 1 gram by mouth twice daily for three days.
Related Therapeutic Areas
Sponsors
Leads: Women and Infants Hospital of Rhode Island