Clinical trial Recruiting at 1 site Observational Ages 18 and up Men only

Registry for Transperineal Laser Ablation of Prostate for Urinary Symptoms

Official title: European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Obstruction (BPO)

Run by University of Florence · NCT06564415 · Data updated 2026-11-12

This study is testing how well Transperineal Laser Ablation of the prostate helps men with urinary problems caused by an enlarged prostate and looks at how different patients respond to the treatment.

More Benign Prostatic Hyperplasia trials

Quick facts

Study typeObservational
Ages18 Years and up
SexMen only
Enrollment2500 (estimated)
SponsorUniversity of Florence
Academic / other
Locations1 site (Florence)
StatusRecruiting
StartedJanuary 11, 2024
Main results expectedJanuary 2034
Study endsJanuary 2034
Registry record updatedAugust 21, 2024
Trial IDNCT06564415 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men aged 18 and older with moderate-to-severe LUTS and a prostate volume of at least 30 mL.

Probably not a fit

Patients with prostate cancer, bladder contractility issues, urethral stenosis, or those who have had previous prostate surgery may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the mid- and long-term effectiveness of Transperineal Laser Ablation of Prostate (TPLA) in treating lower urinary tract symptoms (LUTS) caused by benign prostatic obstruction. It will collect data on patient-reported outcomes, flowmetry parameters, and safety from patients undergoing TPLA. The study also seeks to identify differences in patient characteristics across treatment centers and explore optimal indications and limitations of TPLA for LUTS.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients suffering from lower urinary tract symptoms due to benign prostatic obstruction.

How similar studies have gone: Other studies have shown promising results with similar laser ablation techniques, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age ≥18 years;
* Prostate volume ≥ 30 mL;
* Moderate-to-severe LUTS according to International Prostatic Symptoms Score (IPSS ≥8)
* Consent to participate;

Exclusion Criteria:

* Absence of consent;
* Subsequent withdrawal of consent;
* Diagnosis or suspicion of prostate cancer at multiparametric magnetic resonance
* Documented bladder impaired contractility
* Urethral stenosis
* Previous prostate surgery

Where it's running

  • AOU Careggi
    Florence, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.