Holmium Laser Enucleation of Prostate(HOLEP) vs Greenlight(XPS) Laser Photoselective Vapo-Enuclea… (NCT01494337) | Clinical Trial Compass
CompletedPhase 4
Holmium Laser Enucleation of Prostate(HOLEP) vs Greenlight(XPS) Laser Photoselective Vapo-Enucleation of Prostate(PVEP)
Canada108 participantsStarted 2012-01
Plain-language summary
The investigators are now proposing to compare two laser techniques for treating Benign prostate hyperplasia (BPH); Holmium Laser Enucleation of the Prostate (HOLEP) versus (greenlight) XPS which is a recently available technology in our center and is more efficient hence our choice to include patients with any size prostate. This will confirm whether the two techniques are equivalent in efficacy and safety independent of size as well as cost. The two techniques are available world wide as standard of care
Who can participate
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
. Ability to give informed consent.
. Lower urinary symptoms (LUTS) secondary to bladder outlet obstruction from BPH.
. Failed medical treatment of BPH.
. International prostate symptom scores (IPSS) \> 15.
. Peak urinary flow rate (Qmax) \< 15 ml/sec.
. Preoperative TRUS (transrectal ultrasound) size of the gland (from 40 to 150 cc).
. Patients in retention secondary to BPH (with cystometrogram (CMG) confirming adequate detrusor pressure if the bladder capacity at time of catheterization is in excess of 1000 ml).
Exclusion criteria
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.
. Patient who have a neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease.
. Active urinary tract infection.
. Presence of active bladder cancer (within the last 2 years).
. Known cancer prostate patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.