Clinical Trial

Antibiotic Prophylaxis for Bladder Botox

Recruiting Phase 4
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Record status
This record was last updated September 3, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
Injection of Botox into the bladder is a common treatment for overactive bladder. Postoperative bladder infection is one of the more frequently reported complications of this procedure. Prophylactic antibiotics given at the time of bladder Botox for the reduction of postoperative bladder infection have not been well studied. The main goal of our study is to determine if prophylactic antibiotics at the time of bladder Botox injection for the treatment of overactive bladder in women reduces postoperative bladder infection. The investigators are proposing a study which will randomize participants into two groups - one receiving Ciprofloxacin and the other receiving placebo pills for three days following the procedure. The primary outcome evaluated will be the difference in postoperative bladder infection between the two groups. The investigators will also investigate differences in reported side effects between the two groups possibly related to antibiotic use. Follow-up will be over six weeks following the procedure.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2020-06-19; most recent amendment 2025-09-02.
Status change: Not Yet Recruiting → Recruiting 2021-10-01
Trial Details
NCT Number NCT04444440
Lead Sponsor University of Alberta
Collaborators: Women and Children's Health Research Institute, Canada
Conditions Idiopathic Overactive Bladder, Postoperative Urinary Tract Infection
Enrollment 202 participants
Start Date 2021-06-28
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-03