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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urologic Diseases; Overactive Bladder; Urinary Incontinence; Overactive Bladder Syndrome
• Intervention / Treatment: Drug: OnabotulinumtoxinA

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Allaa Fadl-Alla; Phone Number: 312-695-8146; Email: Allaa.Fadlalla@northwestern.edu
• Study Contact Backup: Name: Alyssa McDonald; Phone Number: 312-695-8146; Email: Alyssa.McDonald@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Medicine
      • Contact: Alyssa McDonald

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intra-detrusor OnabotulinumtoxinA Injection; Injection of intra-detrusor OnabotulinumtoxinA into the bladder will be performed.	Drug: OnabotulinumtoxinA; Intra-detrusor OnabotulinumtoxinA is commonly known as botox; Other Names: Botox
No Intervention: No intra-detrusor OnabotulinumtoxinA Injection; Injection of intra-detrusor OnabotulinumtoxinA into the bladder will not be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder.	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in safety/ adverse effects	Identifying changes in post-op urinary retention, gross hematuria, UTI, ED visits and any additional complications.	90 days
Difference in patient REDCap surveys (gross hematuria dysuria, incontinence)	Identifying symptom resolution at different time points (1 month, 3 months, 6 months)	6 months
Difference in efficacy endpoints (3-month clinic/telephone follow-up)	Identifying efficacy endpoints as they relate to the use of anti-cholinergics, incontinence survey, post void residuals, continence pads requirements if any.	3 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: University of Alberta; Ohio State University; University of Calgary
• Investigators: Principal Investigator: Amy Krambeck, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Urologic Diseases; Urinary Bladder, Overactive; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Hydrolases; Enzymes; Enzymes and Coenzymes; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Metalloproteases; Bacterial Proteins; Bacterial Toxins; Toxins, Biological; Botulinum Toxins, Type A
• Other Study ID Numbers: STU00218130

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes