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

NCT05878951 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

OnabotulinumtoxinA

Intra-detrusor OnabotulinumtoxinA is commonly known as botox

Sponsors & Collaborators

  • University of Calgary

    collaborator OTHER

  • Ohio State University

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • Northwestern University

    lead OTHER

Principal Investigators

  • Amy Krambeck, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-13
Primary Completion
2026-06-01
Completion
2026-08-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT05878951 on ClinicalTrials.gov