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Phase 2
Phase 3
Age: 18Years - 89Years
MALE
ID05878951

Study of Botox Injections During Holmium Laser Surgery for Men with Overactive Bladder Symptoms

Led by Northwestern University · Updated on 2026-06-04

66

Participants Needed

1

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the safety and effects of injecting OnabotulinumtoxinA, also known as botox, into the bladder during holmium laser enucleation of the prostate HoLEP in men who have overactive bladder symptoms, including those with urge incontinence. The study focuses on men experiencing bothersome urinary urgency and incontinence related to benign prostatic hyperplasia BPH. Participants will be randomly assigned to one of two groups one receiving intra-detrusor OnabotulinumtoxinA injections into the bladder at the time of HoLEP, and the other not receiving these injections. The treatment is being studied during the HoLEP procedure to assess its impact on urinary symptoms. During the study, men will complete patient questionnaires and have follow-up assessments at various intervals including 3 months, 6 months, and 12 months to monitor symptom improvement and safety. Researchers will track changes in overactive bladder symptoms, adverse effects, and patient-reported urinary issues. The total observation period for the primary outcome is 12 months, with additional safety and efficacy evaluations throughout the study.

CONDITIONS

Brief Title

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

Research Team

A

Alyssa McDonald

A

Allaa Fadl-Alla

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