NCT05878951PHASE2, PHASE3Recruiting

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

Northwestern University

Start Date

7/13/2023

Completion Date

12/31/2026

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.

Eligibility Criteria

Age Range: 18 years to 89 years

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

Interventions

DRUG

OnabotulinumtoxinA

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Conditions

Urinary IncontinenceOveractive Bladder SyndromeOveractive BladderUrologic Diseases

Locations

Northwestern Medicine

Chicago, Illinois 60611

United States