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

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05878951
• Other study ID #: STU00218130
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 13, 2023
• Est. completion date: August 24, 2024

Study information

• Verified date: October 2023
• Source: Northwestern University
• Contact: Alyssa McDonald
• Phone: 312-695-8146
• Email: Alyssa.McDonald[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 24, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• OnabotulinumtoxinA
Intra-detrusor OnabotulinumtoxinA is commonly known as botox

Locations

Country	Name	City	State
United States	Northwestern Medicine	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Northwestern University	Ohio State University, University of Alberta, University of Calgary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in safety/ adverse effects	Identifying changes in post-op urinary retention, gross hematuria, UTI, ED visits and any additional complications.	90 days
Secondary	Difference in patient REDCap surveys (gross hematuria dysuria, incontinence)	Identifying symptom resolution at different time points (1 month, 3 months, 6 months)	6 months
Secondary	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