NCT04444440

Antibiotic Prophylaxis for Bladder Botox

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 202 (estimated)
• Sponsor: University of Alberta · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will be a single-centred, double-blinded, randomized, placebo-controlled trial. Recruitment will be undertaken at two Urogynecology/Urology sites associated with the University of Alberta in Edmonton, Alberta. Participants will be randomized to treatment or placebo arm with a 1:1 allocation ratio. Patients and surgeons will be blinded. On the day of the procedure, a urine culture will be collected preoperatively to identify pre-existing bacteriuria. Technique and dose of Botox injection will be at the discretion of the operating physician. Trigone-sparing technique with injection of 100 to 200 units of Botox distributed across 10 to 20 sites is generally used at our centre. Follow-up will occur over a six-week postoperative period. A questionnaire will be used at each follow-up encounter to screen patients for urinary tract infection symptoms, voiding dysfunction, and other adverse events potentially related to the prophylactic antibiotics. Urine cultures will be collected to confirm infection for patients developing postoperative symptoms.

Conditions

• Idiopathic Overactive Bladder
• Postoperative Urinary Tract Infection

Interventions

Type	Name	Description
DRUG	Ciprofloxacin	Fluoroquinolone antibiotic.
OTHER	Placebo Pill	Placebo Pill

Timeline

• Start date: 2021-06-28
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2020-06-23
• Last updated: 2025-09-03

Locations

1 site across 1 country: Canada