European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms
European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Obstruction (BPO)
University of Florence
2,500 participants
Jan 11, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria4
- Age ≥18 years;
- Prostate volume ≥ 30 mL;
- Moderate-to-severe LUTS according to International Prostatic Symptoms Score (IPSS ≥8)
- Consent to participate;
Exclusion Criteria6
- 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
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Interventions
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.
Locations(1)
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NCT06564415