Actively Recruiting
Antibiotic Prophylaxis for Bladder Botox
Led by University of Alberta · Updated on 2025-09-03
202
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
Sponsors
U
University of Alberta
Lead Sponsor
W
Women and Children's Health Research Institute, Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Antibiotic Prophylaxis for Bladder Botox
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Age 18 years or older
- Diagnosed with idiopathic overactive bladder who have not responded to medical management
You will not qualify if you...
- Neurogenic overactive bladder caused by neurologic diseases like multiple sclerosis, spinal cord injury, or Parkinson's disease
- Allergy or hypersensitivity to Botox or its components
- Current urinary tract infection
- Symptomatic urinary retention or post-void residual urine greater than 200 mL
- Unwilling or unable to start clean intermittent catheterization after treatment if needed
- Allergy or hypersensitivity to Ciprofloxacin or other fluoroquinolones
- Taking Tizanidine or Agomelatine medications
- Currently on antibiotic therapy for any reason
- Male
- Younger than 18 years
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Urogynecology Clinic - Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H3V9
Actively Recruiting
Research Team
E
Erin Kelly, MD FRCSC
CONTACT
J
Jane Schulz, MR FRCSC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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