Methenamine Hippurate After BOTOX-A Injections for Overactive Bladder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, non-inferiority trial will compare methenamine hippurate to routine antibiotic prophylaxis in preventing UTIs within 30 days after intradetrusor onabotulinumtoxinA injections for women with overactive bladder. Participants are 164 women randomized 1:1 to receive either methenamine hippurate or an antibiotic prophylaxis post-procedure, with UTIs within 30 days as the primary outcome and patient satisfaction as a secondary outcome measured by FACIT-TS-G. The study aims to determine non-inferiority of methenamine hippurate regarding infection rates and also explores patient-reported satisfaction with the prophylactic regimens. Conducted at Women & Infants Hospital in Providence, RI, the trial excludes men and individuals with certain medical histories or current conditions that may affect bladder function or infection risk.

Why it matters

Who can join: the full rules

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

Where it's running

• Women & Infants Hospital
  Providence, Rhode Island, United States Recruiting

Study contacts

• Principal investigator: Vivian Sung, MD, MPH — Women & Infants Hospital
• Study coordinator: Colin Russell, MD, MPH
• Email: CoRussell@wihri.org
• Phone: 401-453-7560

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.