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New laser option for men whose prostate symptoms return after first treatment

NCT ID NCT07016620

Symptom relief Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a laser treatment for men over 40 whose enlarged prostate symptoms returned after a prior minimally invasive procedure. The treatment is done in the doctor's office and aims to improve urination and sexual function, potentially avoiding more invasive surgery. About 20 participants will be enrolled at the Cleveland Clinic.

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.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Sep 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.

Who is studied

Benign Prostatic Hyperplasia (BPH) salvage therapy patients

Ages

40 years and older

Sex

Male participants only

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: * Men \> 40 years old * History of Minimally invasive BPH procedure within the last 5 years. * IPSS \>= 12 * Prostate Volume 30 - 80 gr as assessed by CT, MRI or TRUS. * PSA \<4 or for patients with PSA 4-10 evaluation has been performed to rule out prostate cancer using biopsy, MRI, biomarker, or surgeon judgement. Labs within 1 year of study initiation * PVR \> 150cc or reduced flow on uroflow likely due to obstruction based on clinical judgement * IIEF-6\>or =10 without medication Exclusion Criteria: * Indwelling catheter or intermittent catheterization * History of urethral strictures * Previous diagnosis of Prostate cancer * Active UTI or prostatitis * Hypoactive detrusor function * Neurogenic bladder (secondary to stroke, Multiple Sclerosis, Parkinson's disease, Spinal cord injury) * Ejaculatory dysfunction (retrograde ejaculation, anorgasmia or anejaculation) * Prior traditional BPH surgery (TURP, PVP, Aquablation, HOLEP, SP) * Presence of obstructive median lobe * Moderate to severe or severe ED based on IIEF-6/SHIM (SHIM of 10) * Peyronie's disease

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia Lower Urinary Tract Symptoms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Benign prostatic hyperplasia (BPH)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

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