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
• Trial end date: 2024-08-24
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborators: Ohio State University; University of Alberta; University of Calgary
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

Criteria

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