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

University of Florence (UNIFI)

Status: Enrolling

Conditions: Benign Prostatic Hyperplasia; Prostatic Diseases

Treatments: Procedure: Transperineal Laser Ablation of Prostate

Study type: Observational

Funder types: Other

Identifiers

NCT06564415

25691

Details and patient eligibility

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.

Enrollment: 2,500 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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