Antibiotic Prophylaxis for Bladder Botox

NCT ID: NCT04444440

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-28
• Study Completion Date: 2026-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment Arm

Ciprofloxacin 500 mg PO every 12 hrs for 3 days following the procedure

Group Type: ACTIVE_COMPARATOR

Ciprofloxacin

Intervention Type: DRUG

Fluoroquinolone antibiotic.

Placebo Arm

Placebo pill PO every 12 hrs for 3 days following the procedure

Group Type: PLACEBO_COMPARATOR

Placebo Pill

Intervention Type: OTHER

Placebo Pill

Interventions

Ciprofloxacin

Fluoroquinolone antibiotic.

Intervention Type: DRUG

Placebo Pill

Placebo Pill

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Women and Children's Health Research Institute, Canada

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Urogynecology Clinic - Royal Alexandra Hospital

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Erin Kelly, MD FRCSC

Role: CONTACT

eckelly@ualberta.ca

780-735-5290

Jane Schulz, MR FRCSC

Role: CONTACT

schulz@ualberta.ca

780-970-4659

Facility Contacts

Erin Kelly, MD FRCSC

Role: primary

eckelly@ualberta.ca

7807355290

Paul Groves, MD FRCSC

Role: backup

pgroves@ualberta.ca

7809991561

Other Identifiers

Pro00101838

Identifier Type: -

Identifier Source: org_study_id