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Laser showdown: which prostate surgery technique is faster and safer?

NCT ID NCT06565741

Disease control Sponsor: Fundacio Puigvert 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial compares two laser methods (MoLEP and ThuFLEP) for removing prostate tissue in men with enlarged prostates (over 80cc). 120 men aged 40-90 who need surgery will be randomly assigned to one of the two lasers. The main goal is to see which technique is faster, while also checking for differences in bleeding, hospital stay, and symptom improvement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Laser (Holmium or Thulium Fiber) for prostate surgery
What this could lead to
If successful, this could show which laser technique removes prostate tissue faster with less bleeding, improving surgical outcomes for men with enlarged prostates.
What could go wrong
This is a small, early-stage trial (120 participants) comparing two established techniques, so differences may be minor. Results may not apply to all surgeons or hospitals.

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

About 120 people

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

Started

Sep 2024

Expected to finish

Sep 2028

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

40 to 90 years

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: * Males aged between 40 and 90 years. * Patients who, due to their lower urinary tract symptoms, are candidates for BPH surgery, including: * Obstructive urinary symptoms evaluated through IPSS with a score \>7 and QoL \> 2 or acute urinary reten on refractory to catheter removal. * Obstructive urinary flow evaluated through uroflowmetry with Qmax\< 15 ml/s, obstruction demonstrated by pressure/flow study, prostatic origin haematuria refractory to medical treatment, or acute urinary retention refractory to catheter removal. * Prostatic volume measured by transabdominal ultrasound, transrectal ultrasound, or magnetic resonance imaging of more than 80 cc. * Prostate-specific antigen (PSA) \< 4 ng/ml, or with multiparametric prostate magnetic resonance imaging reporting PIRADS \< 3 or equal to 3 with PSA density \< 15%. Exclusion Criteria: * Diagnosis, suspicion, or history of urethral stenosis or urethral surgery. * History of prostate surgery or pelvic radiotherapy. * Diagnosis or suspicion of prostate cancer or urothelial cancer. * Body mass index superior to 30.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia

As listed by the trial registrant

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

Endoscopic anatomical enucleation of the prostate (EEAP) Prostatic hyperplasia Surgery

How to take part

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

  1. The places running it

    3 sites. 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

  • Clinic Hospital of Barcelona

    RECRUITING

    Barcelona, BARCELONA, 08036, Spain

  • Fundacio Puigvert

    RECRUITING

    Barcelona, BARCELONA, 08025, Spain

  • Hospital Univesitari de Bellvitge

    RECRUITING

    L'Hospitalet de Llobregat, BARCELONA, 08907, Spain

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