The study objective is to compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy in sexually active men.
Who can participate
Age range
45 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
. Sexually active male subjects ≥ 45 years of age who have persistent non-neurogenic lower urinary tract symptoms refractory to first-line treatment with single agent Alpha Adrenoceptor Antagonist therapy
. Subject is willing and able to answer all domains of MSHQ
. Completed IPSS questionnaire with score ≥ 13 within 6 months prior to enrollment
. Peak urinary flow rate (Qmax): ≤ 15 ml/sec with minimum voided volume of ≥ 150 ml within 6 months prior to enrollment
. Post-void residual (PVR) ≤250 ml within 6 months prior to enrollment
. Prostate volume ≥ 30 ml as measured by transrectal ultrasound or Magnetic Resonance Imaging within 3 months prior to enrollment
. Subject is willing and capable of providing informed consent
. Subject is willing and capable of participating in all visits associated with this study at an approved clinical study site and at the intervals defined by this Clinical Investigational Plan (CIP)
Exclusion criteria
. Inability to participate in full duration of study
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
International Prostate Symptom Score (IPSS) change
Timeframe: From Baseline to 12 months
2
Male Sexual Health Questionnaire (MSHQ) total score change