Clinical Trial

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

Recruiting Phase 2/3
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 4 changes
notable Primary completion pushed: 2026-06-01 -> 2026-09-01 2026-06-05
minor Completion pushed: 2026-08-24 -> 2026-12-31 2026-06-05
notable Enrollment reduced: 80 -> 66 participants 2026-05-01
notable Primary completion pushed: 2026-05-01 -> 2026-06-01 2026-05-01
Trial Details
NCT Number NCT05878951
Lead Sponsor Northwestern University
Collaborators: University of Calgary, Ohio State University, University of Alberta
Conditions Urinary Incontinence, Overactive Bladder Syndrome, Overactive Bladder, Urologic Diseases
Enrollment 66 participants
Start Date 2023-07-13
Primary Completion 2026-09-01 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-04