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NOT YET RECRUITING
NCT06953271
PHASE4

Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection

Sponsor: Women and Infants Hospital of Rhode Island

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

164

Start Date

2025-05-15

Completion Date

2027-01-01

Last Updated

2025-05-01

Healthy Volunteers

No

Interventions

DRUG

Methenamine Hippurate

Drug: Methenamine hippurate 1 gram by mouth twice daily for three days.

DRUG

Typically 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.

Locations (1)

Women & Infants Hospital

Providence, Rhode Island, United States