Actively Recruiting

Age: 18Years +
MALE
NCT06564415

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

Led by University of Florence · Updated on 2024-08-21

2500

Participants Needed

1

Research Sites

520 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Prostate volume of 30 mL or more
  • Moderate-to-severe lower urinary tract symptoms with an International Prostatic Symptoms Score (IPSS) of 8 or higher
  • Consent to participate in the study
Not Eligible

You will not qualify if you...

  • No consent or withdrawal of consent
  • Diagnosis or suspicion of prostate cancer on multiparametric magnetic resonance
  • Documented bladder impaired contractility
  • Urethral stenosis
  • Previous prostate surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

AOU Careggi

Florence, Italy, 50134

Actively Recruiting

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Research Team

F

Francesco Sessa

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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