Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection
- Conditions
- Overactive Bladder (OAB)Urinary Tract Infection (Diagnosis)
- Interventions
- Drug: Typically prescribed oral antibiotic prophylaxis
- Registration Number
- NCT06953271
- Lead Sponsor
- Women and Infants Hospital of Rhode Island
- 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 (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.
- 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 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 Methenamine hippurate is an oral non-antibiotic antiseptic medication widely used in the prevention of recurrent UTIs.
164 women will be randomly assigned to each treatment option: 82 to methenamine hippurate and 82 to routinely prescribed antibiotic prophylaxis. The primary outcome of UTI rates within 30 days of the BOTOX-A procedure will be calculated for each study arm. The FACIT-TS-G will be administered to participants at the conclusion of the 30-day period.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 164
- 18 years of age or older
- undergoing intradetrusor BOTOX-A injections in the office setting for overactive bladder
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Typically prescribed oral antibiotic prophylaxis 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. Methenamine hippurate prophylaxis Methenamine Hippurate Participants in the experimental arm will receive methenamine hippurate 1 gram by mouth twice daily for three days.
- Primary Outcome Measures
Name Time Method Acute Urinary Tract Infection Date of the BOTOX-A injection to 30 days after the procedure Presence of a urinary tract infection (UTI) within 30 days from intradetrusor BOTOX-A injection. UTI will be defined as positive lower urinary tract symptoms (dysuria, hematuria, and/or worsened urinary urgency or frequency) and a positive urine culture.
- Secondary Outcome Measures
Name Time Method Medication Satisfaction Completed over the phone >30 days after BOTOX-A injection. We will administer the validated Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G Version 4) survey assessing medication-related (i.e. typical antibiotic or methenamine hippurate) satisfaction and perceived adverse events over the phone \>30 days after intradetrusor BOTOX-A injection. The submission of the survey marks the conclusion of the participant's participation in the study.
Trial Locations
- Locations (1)
Women & Infants Hospital
🇺🇸Providence, Rhode Island, United States