Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexMale
Age18-89
SponsorNorthwestern University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- OnabotulinumtoxinA
Treatment groups
66 Participants
are divided into 2 treatment groupsSponsors and collaborators
Northwestern University
Lead sponsor
University of Calgary
Collaborator
Ohio State University
Collaborator
University of Alberta
Collaborator
Source ClinicalTrials.gov