Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection

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

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.

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.

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
• 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