Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05878951

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Overactive Bladder Overactive Bladder Syndrome Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–89 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Alyssa McDonald

CONTACT

About this study

Patients with significant preoperative urgency and/or urge urinary incontinence (UUI) along with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) may require post-HoLEP anticholinergic, B-3 agonist, or intravesical OnabotulinumtoxinA administration. This injection is a guideline recommended for treatment in patients with severe irritative LUTS (urgency, UUI) and overactive bladder.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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.

Exclusion criteria

  • 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

Treatment and study plan

OnabotulinumtoxinA

Drug

Intra-detrusor OnabotulinumtoxinA is commonly known as botox

Other names: Botox

Primary outcomes

  1. Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder.

    Time frame: 12 months

    Examine the safety and effect of intra-detrusor botulinum toxin injections at the time of helium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.

Secondary outcomes

  1. Difference in safety/ adverse effects

    Time frame: 90 days

    Identifying changes in post-op urinary retention, gross hematuria, UTI, ED visits and any additional complications.

  2. Difference in patient REDCap surveys (gross hematuria dysuria, incontinence)

    Time frame: 6 months

    Identifying symptom resolution at different time points (1 month, 3 months, 6 months)

  3. Difference in efficacy endpoints (3-month clinic/telephone follow-up)

    Time frame: 3 months

    Identifying efficacy endpoints as they relate to the use of anti-cholinergics, incontinence survey, post void residuals, continence pads requirements if any.

Study contacts

Contact information is provided by the study sponsor or research team.

Allaa Fadl-Alla

CONTACT

[email protected]

312-695-8146

Alyssa McDonald

CONTACT

[email protected]

312-695-8146

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Ohio State University
  • University of Alberta
  • University of Calgary

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 30, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.