Recruiting

Antibiotic Prophylaxis

Sponsor:

University of Alberta

Code:

NCT04444440

Conditions

Idiopathic Overactive Bladder

Postoperative Urinary Tract Infection

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ciprofloxacin

Placebo Pill

Study Details

Brief 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.

Conditions

Idiopathic Overactive Bladder

Postoperative Urinary Tract Infection

Study ID

NCT04444440

Start date

Jun 28, 2021

Status verified date

Sep, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with idiopathic OAB diagnosed clinically who have failed medical management
  • Female
  • Age ≥ 18

Exclusion Criteria:

  • Patients with neurogenic OAB (OAB with potential underlying neurologic cause - multiple sclerosis, spinal cord injury, Parkinson's disease, other)
  • Contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, current urinary tract infection, symptomatic urinary retention or PVR > 200 mL, unwillingness or inability to initiate CIC post-treatment if required.
  • Contraindication to oral Ciprofloxacin - hypersensitivity or allergy to Ciprofloxacin or other fluoroquinolone, concurrently taking Tizanidine or Agomelatine.14
  • Active antibiotic therapy for any indication at the time of Botox injection - increased risk of adverse reaction with combining antibiotics, reduced risk of UTI with additional antibiotic.
  • Male
  • Age < 18
  • Pregnant and/or breastfeeding

Study Design

Enrollment

202 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Ciprofloxacin

Fluoroquinolone antibiotic.

Placebo Pill

Placebo Pill

Primary outcome measure

  • Rate of Postoperative Urinary Tract Infection [ Time Frame: 2 weeks following the procedure ]

Central Contacts and Locations

Central contacts

Erin Kelly, MD FRCSC

780-735-5290eckelly@ualberta.ca

Jane Schulz, MR FRCSC

780-970-4659schulz@ualberta.ca

Locations

Urogynecology Clinic - Royal Alexandra Hospital

Recruiting

Edmonton, Alberta, Canada, T5H3V9

Contacts

Erin Kelly, MD FRCSC

7807355290eckelly@ualberta.ca

Paul Groves, MD FRCSC

7809991561pgroves@ualberta.ca

Principal Investigator:

Erin Kelly, MD FRCSC

More Information

Sponsor

University of Alberta

Last update posted

Sep 3, 2025

Last verified

Sep, 2025

Keywords

  • prophylaxis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2025-09-03.