Actively Recruiting
Prophylactic Antibiotics After Neurogenic Overactive Bladder Treatment With Intradetrusor Botox to Reduce Postoperative UTI: Randomized Placebo-Controlled Trial
Led by University of Alberta · Updated on 2026-05-07
160
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of preventative antibiotics to reduce the risk of bladder infection after Botox injections for neurogenic overactive bladder. This condition occurs in people with neurological disorders like multiple sclerosis, Parkinson's disease, spinal cord injury, or stroke. The trial aims to determine whether giving antibiotics at the time of Botox treatment lowers the rate of postoperative urinary tract infections. This is a randomized, double-blinded study led by the University of Alberta, providing training opportunities for new researchers. Participants will be randomly assigned to receive either ciprofloxacin, an antibiotic, or a placebo pill twice daily for three days after the bladder Botox procedure. The Botox injection technique usually involves a trigone-sparing method with 200 units spread across 10 to 20 sites, but the exact method is at the physician's discretion. A urine culture is taken before the procedure to check for existing infections. During the six weeks after treatment, patients will have regular follow-ups where questionnaires will screen for urinary infection symptoms, voiding issues, or other side effects possibly related to antibiotics. Urine cultures will confirm infections if symptoms appear. The main outcome measured is the rate of urinary tract infections two weeks after the procedure, with additional assessments at one and six weeks. The study also monitors other adverse events during this time.
CONDITIONS
Brief Title
Antibiotic Prophylaxis for Neurogenic Bladder Botox
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with neurogenic overactive bladder due to neurological conditions such as multiple sclerosis, Parkinson's disease, spinal cord injury, stroke, or other neurological causes
- Age 18 years or older
- Able to read, speak, and write in English
- No contraindications to Botox injection, including no hypersensitivity, no symptomatic urinary retention or post-void residual > 200 mL, and willingness to initiate clean intermittent catheterization if needed
- No contraindications to oral ciprofloxacin, including no allergy to fluoroquinolones and no concurrent use of Tizanidine or Agomelatine
- Not currently on antibiotic therapy for any reason at the time of Botox injection
- Not pregnant or breastfeeding
- No active symptomatic urinary tract infection on the day of the procedure
You will not qualify if you...
- Participants with idiopathic overactive bladder
- Age under 18 years
- Unable to read, speak, or write in English
- Contraindications to Botox injection, such as hypersensitivity, symptomatic urinary retention or post-void residual > 200 mL, or unwillingness/inability to start clean intermittent catheterization if required
- Contraindications to oral ciprofloxacin, including allergy to fluoroquinolones or concurrent use of Tizanidine or Agomelatine
- Receiving antibiotic therapy at the time of Botox injection
- Pregnant or breastfeeding individuals
- Active symptomatic urinary tract infection on the day of the procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive either ciprofloxacin or placebo pills every 12 hours for 3 days following the Botox injection procedure.
1 procedure day visit (in-person)
Duration - 6 weeks
Participants are monitored for postoperative urinary tract infection symptoms, voiding dysfunction, and other adverse events. Urine cultures are collected if symptoms occur.
Follow-up visits at 1, 2, and 6 weeks post-procedure
Trial Site Locations
Total: 1 location
1
University of Alberta
Edmonton, Alberta, Canada, T6G2R3
Actively Recruiting
Research Team
J
Joseph LaBossiere, MD FRCSC
P
Paul Groves, MR FRCSC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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