Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
NCT04444440

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female
  • Age 18 years or older
  • Diagnosed with idiopathic overactive bladder who have not responded to medical management
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Urogynecology Clinic - Royal Alexandra Hospital

Edmonton, Alberta, Canada, T5H3V9

Actively Recruiting

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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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Antibiotic Prophylaxis for Bladder Botox | DecenTrialz