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Antibiotic Prophylaxis for Bladder Botox

NCT04444440 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2025-09-03

No results posted yet for this 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.

Conditions

  • Idiopathic Overactive Bladder
  • Postoperative Urinary Tract Infection

Interventions

DRUG

Ciprofloxacin

Fluoroquinolone antibiotic.

OTHER

Placebo Pill

Placebo Pill

Sponsors & Collaborators

  • Women and Children's Health Research Institute, Canada

    collaborator OTHER

  • University of Alberta

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-28
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04444440 on ClinicalTrials.gov