Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Women and Infants Hospital of Rhode Island
Study ID
NCT06953271
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Overactive Bladder (OAB)
  • Urinary Tract Infection (Diagnosis)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methenamine Hippurate — DRUG
    Drug: Methenamine hippurate 1 gram by mouth twice daily for three days.
  • Typically prescribed oral antibiotic prophylaxis — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 15, 2025
Status verified
Apr 2025
Primary completion
May 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Acute Urinary Tract Infection [ Time Frame: Date of the BOTOX-A injection to 30 days after the procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Women & Infants HospitalProvidenceRhode Island02903-

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By research site
Women & Infants Hospital· Providence, RI

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