Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
ID04444440

Prophylactic Antibiotics During Treatment of Idiopathic Overactive Bladder With Intradetrusor OnabotulinumtoxinA for Reduction of Postoperative UTI: A Randomized Blinded Placebo-Controlled Trial

Led by University of Alberta · Updated on 2025-09-03

202

Participants Needed

1

Research Sites

N/A

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

Researchers are studying whether giving antibiotics at the time of bladder Botox injection can reduce the chance of bladder infections afterward in women with idiopathic overactive bladder. The study focuses on women aged 18 and older who have not responded to medical treatments and are receiving Botox injections to help manage their symptoms. The goal is to see if taking antibiotics after the procedure prevents urinary tract infections and to check for any side effects linked to antibiotic use. Participants will be randomly assigned to one of two groups: one receiving the antibiotic Ciprofloxacin and the other receiving placebo pills. Both groups will take their assigned pills twice daily for three days after the Botox procedure. The Botox injection technique and dose, usually between 100 and 200 units across 10 to 20 sites in the bladder, will be determined by the doctor. This trial is double-blinded, meaning neither the patients nor the doctors will know who receives antibiotics or placebo. During the six weeks following the procedure, participants will have regular follow-up visits where questionnaires will assess symptoms of urinary tract infection, voiding issues, and any side effects. Urine cultures will be taken before the procedure and if infection symptoms appear postoperatively to confirm infections. The primary outcome is the rate of urinary tract infections two weeks after treatment, with additional monitoring at one and six weeks. The study also tracks other adverse events potentially related to the antibiotic use.

CONDITIONS

Brief Title

Antibiotic Prophylaxis for Bladder Botox

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with idiopathic overactive bladder diagnosed clinically who have failed medical management
  • Female
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Patients with neurogenic overactive bladder caused by neurological conditions such as multiple sclerosis, spinal cord injury, or Parkinson's disease
  • Contraindication to Botox injection including hypersensitivity to botulinum toxin, current urinary tract infection, symptomatic urinary retention or post-void residual over 200 mL, or inability/unwillingness to use catheterization if needed
  • Contraindication to oral Ciprofloxacin such as allergy or concurrent use of Tizanidine or Agomelatine
  • Active antibiotic therapy at the time of Botox injection
  • Male
  • Age under 18 years
  • Pregnant or breastfeeding

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 3 days following the procedure

Participants receive intradetrusor Botox injection followed by 3 days of either antibiotic or placebo pills.

1 procedure day with medication taken twice daily for 3 days

Post-operative Follow-up

Duration - 6 weeks following the procedure

Participants are monitored for urinary tract infection symptoms and other adverse events with questionnaires and urine cultures if symptoms develop.

Multiple follow-up visits at 1, 2, and 6 weeks post-procedure

Trial Site Locations

Total: 1 location

1

Urogynecology Clinic - Royal Alexandra Hospital

Edmonton, Alberta, Canada, T5H3V9

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Research Team

E

Erin Kelly, MD FRCSC

J

Jane Schulz, MR FRCSC

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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