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

• Sponsor: Northwestern University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05878951
• Collaborator: University of Calgary (Other), Ohio State University (Other), University of Alberta (Other)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14.8
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence; Overactive Bladder Syndrome; Overactive Bladder; Urologic Diseases	Drug: OnabotulinumtoxinA	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Aug 24, 2024

Arms and Interventions

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
No Intervention: No intra-detrusor OnabotulinumtoxinA Injection Injection of intra-detrusor OnabotulinumtoxinA into the bladder will not be performed.

Outcome Measures

Primary Outcome Measures

1. 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

1. Difference in safety/ adverse effects [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) [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) [3 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Medicine	Chicago	Illinois	United States	60611

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amy Krambeck, Professor of Urology, Northwestern University
• ClinicalTrials.gov Identifier: NCT05878951
• Other Study ID Numbers: STU00218130
• First Posted: May 30, 2023
• Last Update Posted: May 30, 2023
• Last Verified: May 1, 2023

• 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
• Additional relevant MeSH terms: Urinary Incontinence; Urinary Bladder, Overactive; Urologic Diseases; Botulinum Toxins, Type A; abobotulinumtoxinA

Study Results

No Results Posted as of May 30, 2023