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

Who is this study for? Patients with Idiopathic Overactive Bladder, Postoperative Urinary Tract Infection
What treatments are being studied? Ciprofloxacin
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with idiopathic OAB diagnosed clinically who have failed medical management

• Female

• Age ≥ 18

Locations
Other Locations
Canada
Urogynecology Clinic - Royal Alexandra Hospital
RECRUITING
Edmonton
Contact Information
Primary
Erin Kelly, MD FRCSC
eckelly@ualberta.ca
780-735-5290
Backup
Jane Schulz, MR FRCSC
schulz@ualberta.ca
780-970-4659
Time Frame
Start Date: 2021-06-28
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 202
Treatments
Active_comparator: Treatment Arm
Ciprofloxacin 500 mg PO every 12 hrs for 3 days following the procedure
Placebo_comparator: Placebo Arm
Placebo pill PO every 12 hrs for 3 days following the procedure
Sponsors
Collaborators: Women and Children's Health Research Institute, Canada
Leads: University of Alberta

This content was sourced from clinicaltrials.gov

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