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RECRUITING
NCT04444440
PHASE4

Antibiotic Prophylaxis for Bladder Botox

Sponsor: University of Alberta

View on ClinicalTrials.gov

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.

Official title: Prophylactic Antibiotics During Treatment of Idiopathic Overactive Bladder With Intradetrusor onabotulinumtoxinA for the Reduction of Postoperative UTI: a Randomized Blinded Placebo-controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

202

Start Date

2021-06-28

Completion Date

2026-06-30

Last Updated

2025-09-03

Healthy Volunteers

No

Interventions

DRUG

Ciprofloxacin

Fluoroquinolone antibiotic.

OTHER

Placebo Pill

Placebo Pill

Locations (1)

Urogynecology Clinic - Royal Alexandra Hospital

Edmonton, Alberta, Canada