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

Last updated: August 18, 2024
Sponsor: University of Florence
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Disorders

Interstitial Cystitis

Bladder Disorders

Treatment

Transperineal Laser Ablation of Prostate

Clinical Study ID

NCT06564415
25691
  • Ages > 18
  • Male

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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 2500
Treatment Group(s): 1
Primary Treatment: Transperineal Laser Ablation of Prostate
Phase:
Study Start date:
January 11, 2024
Estimated Completion Date:
January 31, 2034

Connect with a study center

  • AOU Careggi

    Florence, 50134
    Italy

    Active - Recruiting

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