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

Recruiting now · Phase 2/Phase 3

Conditions studied: Urinary Incontinence, Overactive Bladder Syndrome, Overactive Bladder, Urologic Diseases

In brief

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.

Key facts

Study ID

NCT05878951

Run by

Northwestern University

People needed

66

Starts

2023-07-13

Expected to finish

2026-12-31

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older, up to 89. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Northwestern Medicine — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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