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European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms

NCT06564415 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2024-08-21

No results posted yet for this study

Summary

The goal of this observational study is to assess mid- and long-term effectiveness of Transperineal Laser Ablation of Prostate (TPLA) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic obstruction measured by need and/or time until surgical retreatment.

Data regarding patient-reported outcomes measures (PROMs), flowmetry parameters and safety about consecutive patients undergoing TPLA will be collected in a dedicated platform.

Secondary objectives of the study are:

* To assess functional and safety outcomes in patients treated with transperineal laser ablation for LUTS due to benign prostatic obstruction;
* To identify possible differences in characteristics of patients treated with transperineal laser ablation among the centers and possible relations between treatment application and outcomes, in order to explore the optimal indications and possible limitations of TPLA for LUTS.

Conditions

  • Benign Prostatic Hyperplasia
  • Prostatic Diseases

Interventions

PROCEDURE

Transperineal Laser Ablation of Prostate

Transperineal Laser Ablation of the Prostate is an ultra minimally-invasive procedure that consists in the insertion trough the perineum skin of laser fibers into the prostatic adenoma, under US guidance. Laser energy generates an area of coagulative necrosis that will bring to a reduction of the prostatic volume.

Sponsors & Collaborators

  • University of Florence

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-11
Primary Completion
2034-01-31
Completion
2034-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06564415 on ClinicalTrials.gov