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

Launched by NORTHWESTERN UNIVERSITY · May 24, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether injecting a medication called OnabotulinumtoxinA (often known as Botox) directly into the bladder during a specific surgery called HoLEP (Holmium Laser Enucleation of the Prostate) can help men who suffer from overactive bladder symptoms. These symptoms can include needing to urinate frequently, waking up at night to use the bathroom, a sudden urge to urinate, or leaking urine when feeling that urgency. The study aims to find out if this treatment is safe and effective for men experiencing these issues.

To participate in this trial, you need to be a male aged between 18 and 89 who is scheduled for the HoLEP surgery and has overactive bladder symptoms. You should be able to read and understand the study materials and be willing to sign a consent form. However, some people may not qualify, such as those with allergies to Botox, certain prior medical treatments, or active urinary infections. If you join the study, you can expect to receive care and monitoring related to your surgery and the treatment being tested.

Gender

MALE

Eligibility 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