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

Description

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

Urinary Incontinence, Overactive Bladder Syndrome, Overactive Bladder, Urologic Diseases

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Study Overview

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Study Details

Study overview

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.

A Multicenter Randomized Controlled Trial Examining the Effects of Intra-detrusor Botulinum Toxin at Time of Holmium Laser Enucleation of the Prostate (HoLEP) in Men With Overactive Bladder (OAB) Symptoms

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

Condition
Urinary Incontinence
Intervention / Treatment

-

Contacts and Locations

Chicago

Northwestern Medicine, Chicago, Illinois, United States, 60611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Males 18 -89 undergoing HoLEP
  • * Component of OAB symptoms including frequency, nocturia, urgency, and/or urge related incontinence
  • * Willing to sign the Informed Consent Form
  • * Able to read, understand, and complete patient questionnaires.
  • * Allergy or hypersensitivity to OnabotulinumtoxinA injections
  • * Patients having a concurrent ureteroscopy +/- laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at the time of their HoLEP
  • * Anticipated need for perineal urethrostomy at the time of HoLEP
  • * Prior pelvic radiation or patients with a history of bladder cancer with or without BCG therapy
  • * Patients who lack decisional capacity
  • * Active urinary tract infection

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwestern University,

Amy Krambeck, MD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

2026-08-24