NCT05878951

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: Male
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	OnabotulinumtoxinA	Intra-detrusor OnabotulinumtoxinA is commonly known as botox

Timeline

• Start date: 2023-07-13
• Primary completion: 2026-05-01
• Completion: 2026-08-24
• First posted: 2023-05-30
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study