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

Phase 2

Recruiting

• Conditions: Urologic Diseases; Overactive Bladder Syndrome; Urinary Incontinence; Overactive Bladder
• Interventions: Drug: OnabotulinumtoxinA

• Registration Number: NCT05878951
• Lead Sponsor: Northwestern University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-05-30
• Study Start: 2023-07-13
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-06-01
• Study Completion: 2026-08-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-detrusor OnabotulinumtoxinA Injection	OnabotulinumtoxinA	Injection of intra-detrusor OnabotulinumtoxinA into the bladder will be performed.

Primary Outcome Measures

Name	Time	Method
Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder.	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 Outcome Measures

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

Trial Locations

Locations (1)

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States