New study pits two prostate procedures Head-to-Head for big glands
NCT ID NCT05155891
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at two procedures—prostate artery embolization (PAE) and holmium laser enucleation (HoLEP)—to see which better eases urinary symptoms caused by an enlarged prostate. It involves 45 men aged 50 or older with prostates larger than 80 grams. The main goal is to measure changes in symptom scores and recovery times.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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45 people
The number who actually took part.
- Started
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Jun 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patient is age 50 or older. 2. Patient has signed informed consent and agrees to attend all follow-up study visits. 3. Patient has had LUTS secondary to BPH or any complications secondary to BPH and qualifying for active intervention. 4. Patient has a baseline IPSS Score \> 13 at baseline. 5. Patient has a prostate size of at least 80 grams and not more than 250 grams, measured by magnetic resonance imaging (MRI) or transrectal ultrasonography (TRUS). 6. Patient has BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated, or refused. 7. Patient must be a candidate for HoLEP or PAE. Exclusion Criteria: 1. Subject has untreated active infection (e.g., active urinary tract infection or prostatitis) 2. Subject has a diagnosis or received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis). 3. Patients with indwelling urinary catheters or those performing self-catheterization. 4. Biopsy proven prostate or bladder cancer. \- Patient with elevated PSA will be counselled by urologist and a shared decision will be made with the patient after discussion about pros and cons of prostate biopsy. 5. Patients with neurogenic bladder disorder. 6. Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition. 7. Patients with prior history transurethral resection of the prostate (TURP), Green Light laser treatment, or other prostate surgical treatments within past year(12 months). 8. Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis. 9. Cardiac condition including congestive heart failure or arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease or known immunosuppression which required hospitalization within the previous 6 months. 10. Acute myocardial infarction, open heart surgery, or cardiac arrest within 180 days prior to the date of informed consent. 11. Patient is interested in future fertility and wish to preserve ejaculation will be excluded from HoLEP arm 12. History of coagulation cascade disorders (which are not normalized by medical treatment before the procedure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding. 13. History of major allergic reaction to iodinated contrast agents will be excluded from PAE arm. 14. History of hypersensitivity to gelatin products will be excluded from PAE arm. 15. Subject has a life expectancy of less than 2 yrs. 16. Post void residual more than 500 ml at baseline. 17. Participation in any other BPH trials during the time of study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Miami
Miami, Florida, 33136, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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