RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-07-13
Study Completion:2026-08-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05878951

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.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males 18 -89 undergoing HoLEP
  2. * Component of OAB symptoms including frequency, nocturia, urgency, and/or urge related incontinence
  3. * Willing to sign the Informed Consent Form
  4. * Able to read, understand, and complete patient questionnaires.
  1. * Allergy or hypersensitivity to OnabotulinumtoxinA injections
  2. * Patients having a concurrent ureteroscopy +/- laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at the time of their HoLEP
  3. * Anticipated need for perineal urethrostomy at the time of HoLEP
  4. * Prior pelvic radiation or patients with a history of bladder cancer with or without BCG therapy
  5. * Patients who lack decisional capacity
  6. * Active urinary tract infection

Contacts and Locations

Study Contact

Alyssa McDonald
CONTACT
312-695-8146
Alyssa.McDonald@northwestern.edu
Allaa Fadl-Alla
CONTACT
312-695-8146
Allaa.Fadlalla@northwestern.edu

Principal Investigator

Amy Krambeck, MD
PRINCIPAL_INVESTIGATOR
Northwestern University

Study Locations (Sites)

Northwestern Medicine
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Amy Krambeck, MD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-13
Study Completion Date2026-08-24

Study Record Updates

Study Start Date2023-07-13
Study Completion Date2026-08-24

Terms related to this study

Additional Relevant MeSH Terms

  • Urinary Incontinence
  • Overactive Bladder Syndrome
  • Overactive Bladder
  • Urologic Diseases