Antibiotic Prophylaxis for Bladder Botox

NCT04444440 · tracked via the Priya Life Science Canada tracker

Sponsor

University of Alberta

Phase

Phase 4

Started

2021-06-28

Last updated

2026-09-22

Condition(s) studied

Idiopathic Overactive BladderPostoperative Urinary Tract Infection

Investigational drug(s) / intervention(s)

Ciprofloxacin →Placebo Pill

Ciprofloxacin: Fluoroquinolone antibiotic.

Placebo Pill: Placebo Pill

Study 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 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients with idiopathic OAB diagnosed clinically who have failed medical management * Female * Age ≥ 18 Exclusion Criteria: * 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

Primary outcome measure(s)

Rate of Postoperative Urinary Tract Infection — 2 weeks following the procedure
new or worsening symptoms (dysuria, hematuria, frequency, urgency, suprapubic/flank pain, fever) AND positive urine culture (\>10\^5 CFU/mL)

Trial sites (1)

Facility	City	Region	Status
Urogynecology Clinic - Royal Alexandra Hospital	Edmonton	Alberta	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04444440 on ClinicalTrials.gov ↗ ← All trials in Canada