Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 89Years
MALE
NCT05878951

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

Led by Northwestern University · Updated on 2026-04-30

66

Participants Needed

1

Research Sites

162 weeks

Total Duration

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Sponsors

N

Northwestern University

Lead Sponsor

U

University of Calgary

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 89Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Males 18 to 89 years old undergoing HoLEP
  • Presence of overactive bladder symptoms including frequency, nocturia, urgency, and/or urge incontinence
  • Willingness to sign the Informed Consent Form
  • Ability to read, understand, and complete patient questionnaires
Not Eligible

You will not qualify if you...

  • Allergy or hypersensitivity to OnabotulinumtoxinA injections
  • Undergoing concurrent ureteroscopy with or without laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery during HoLEP
  • Anticipated need for perineal urethrostomy at the time of HoLEP
  • Prior pelvic radiation or history of bladder cancer with or without BCG therapy
  • Lack of decisional capacity
  • Active urinary tract infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Northwestern Medicine

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

A

Alyssa McDonald

CONTACT

A

Allaa Fadl-Alla

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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