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Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 30 days later Sep 1, 2026 → Oct 2026
See other at-risk trials from Northwestern University

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing Show 5 more changesShow less
    • Primary completion pushed from Sep 1, 2026 to Oct 2026
    • Study completion moved earlier from Dec 31, 2026 to Nov 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Site details revised
  2. Primary completion pushed from Jun 1, 2026 to Sep 1, 2026
    • Study completion pushed from Aug 24, 2026 to Dec 31, 2026
    v8
  3. Primary completion pushed from May 1, 2026 to Jun 1, 2026
    • Enrollment reduced: 80 → 66 participants
    v7
  4. Primary completion date: Oct 1, 2025 to May 1, 2026v6
  5. Primary completion date: Jun 1, 2025 to Oct 1, 2025v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Jun 1, 2024 to Jun 1, 2025
    • Study completion date: Aug 24, 2024 to Aug 24, 2026
    v4
  2. Site contact updated
    • Study title shortened, about 8 words
    v3
  3. Start date changed from estimate of Jun 1, 2023 to Jul 13, 2023v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The objective of our multi-center randomized single-blind study is to examine the safety and effect of intra-detrusor OnabotulinumtoxinA injections at the time of holium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.
Trial Details
NCT Number NCT05878951
Lead Sponsor Northwestern University
Collaborators: University of Calgary, Ohio State University, University of Alberta
Conditions
(from sponsor)		 Urinary Incontinence, Overactive Bladder Syndrome, Overactive Bladder, Urologic Diseases
Related terms Urinary Bladder, Overactive, Urinary Incontinence, Urologic Diseases
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov