Antibiotic Prophylaxis for Bladder Botox

NCT04444440 | Recruiting Phase 4

• 1 other identifier: Pro00101838
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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

Keywords

prophylaxis

Outcome Measures

Primary Outcomes (1)

• Rate of Postoperative Urinary Tract Infection

  new or worsening symptoms (dysuria, hematuria, frequency, urgency, suprapubic/flank pain, fever) AND positive urine culture (\>10\^5 CFU/mL)

  2 weeks following the procedure

Secondary Outcomes (2)

• Rate of Postoperative Urinary Tract Infection Rate

  1 and 6 weeks following the procedure

• Rate of Other Adverse Events

  1, 2 and 6 weeks following the procedure

Study Arms (2)

Treatment Arm

ACTIVE COMPARATOR

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

Drug: Ciprofloxacin

Placebo Arm

PLACEBO COMPARATOR

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

Other: Placebo Pill

Interventions

Ciprofloxacin DRUG

Fluoroquinolone antibiotic.

Treatment Arm

Placebo Pill OTHER

Placebo Pill

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Women and Children's Health Research Institute, Canada: collaborator

Study Sites (1)

Urogynecology Clinic - Royal Alexandra Hospital

Edmonton, Alberta, T5H3V9, Canada

RECRUITING

MeSH Terms

Interventions

Ciprofloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Erin Kelly, MD FRCSC

CONTACT

780-735-5290; eckelly@ualberta.ca

Jane Schulz, MR FRCSC

CONTACT

780-970-4659; schulz@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized at a 1:1 allocation ratio to two parallel treatment arms - intervention versus placebo

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 23, 2020
• Study Start: June 28, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)