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New study pits two prostate procedures Head-to-Head for big glands

NCT ID NCT05155891

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

45 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

50 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • University of Miami

    Miami, Florida, 33136, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.