Status:
RECRUITING
Antibiotic Prophylaxis for Bladder Botox
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Women and Children's Health Research Institute, Canada
Conditions:
Idiopathic Overactive Bladder
Postoperative Urinary Tract Infection
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 a...
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 i...
Eligibility Criteria
Inclusion
- Patients with idiopathic OAB diagnosed clinically who have failed medical management
- Female
- Age ≥ 18
Exclusion
- 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
Key Trial Info
Start Date :
June 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT04444440
Start Date
June 28 2021
End Date
June 30 2026
Last Update
September 3 2025
Active Locations (1)
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1
Urogynecology Clinic - Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H3V9