Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Sym… (NCT05878951) | Clinical Trial Compass
RecruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
United States66 participantsStarted 2023-07-13
Plain-language 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.
Who can participate
Age range
18 Years – 89 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder.