NCT04791579

Antibiotic Prophylaxis for Neurogenic Bladder Botox

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Injection of Botox into the bladder is a procedure used to treat neurogenic overactive bladder at the Dianne and Irving Kipnes Urology Centre in the Kaye Edmonton Clinic. A common complication following bladder Botox is bladder infection. There are no well-studied preventative antibiotics given at the time of bladder Botox for the reduction of post-operative bladder infection. We are proposing a research study that will randomize participants into two groups - one receiving antibiotics and the other receiving placebo pills following bladder Botox. The main goal of our study is to determine if preventative antibiotics at the time of bladder Botox injection reduces post-operative bladder infection. It will provide a valuable learning opportunity for a trainee starting their academic career through working closely with established researchers across two disciplines. We hope the results of our study can ultimately be used to improve outcomes and safety for a common Urologic procedure. In addition, findings from our study could help reduce unnecessary use of antibiotics resulting in cost savings in the health care system and reduction in the risk of antibiotic resistance.

Detailed description

This study will be a single-centred, double-blinded, randomized, placebo- controlled trial. Recruitment will be undertaken in the Urology clinic in the Urology Centre at the Kaye Edmonton Clinic in Edmonton, AB. 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 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

• Neurogenic Bladder
• Post-operative Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Ciprofloxacin	Fluoroquinolone antibiotic
DRUG	Placebo	Placebo pill

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-03-31
• Completion: 2026-08-31
• First posted: 2021-03-10
• Last updated: 2026-03-16

Locations

1 site across 1 country: Canada