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Antibiotic Prophylaxis for Bladder Botox

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Jun 30, 2026 → Jun 30, 2028
See other at-risk trials from University of Alberta

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jun 30, 2026 to Jun 30, 2028
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Collaborators: details revised at 1 of 1 entry
  2. Primary and study completion dates: Jun 30, 2025 to Jun 30, 2026v11
  3. Start date: Jul 6, 2021 to Jun 28, 2021v10
  4. Re-verified, no change to tracked fieldsv9
  5. Primary and study completion dates: Dec 31, 2023 to Jun 30, 2025v8
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  1. Primary and study completion dates: Dec 31, 2022 to Dec 31, 2023v7
  2. Re-verified, no change to tracked fieldsv6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2021 to Jul 6, 2021
    v5
  4. Start date: Jan 2021 to May 2021v4
  5. Start date: Sep 1, 2020 to Jan 2021v3
  6. Primary endpoint revised
    • Secondary endpoints revised (2)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04444440
Lead Sponsor University of Alberta
Collaborators: Women and Children's Health Research Institute, Canada
Conditions
(from sponsor)		 Idiopathic Overactive Bladder, Postoperative Urinary Tract Infection
Enrollment 202 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov