European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Obstruction (BPO): study protocol of a prospective multicenter trial. (Preprint)

BACKGROUND Transperineal Laser Ablation of Prostate (TPLA) is an emerging minimally invasive technique for the treatment of Benign Prostatic Obstruction (BPO). OBJECTIVE To design a multicenter prospective registry to collect data on patients treated with TPLA for BPO at several European referral centers to overcome the current limited evidence. METHODS The study is designed as a nonprofit prospective multicentre observational cohort registry. The primary objective is to assess the mid- and long-term effectiveness of TPLA. Secondary objectives are to assess functional and safety outcomes and to identify possible predictors of efficacy or failure of the technique. All candidates for TPLA among the participant centres will be evaluated for enrollment. The estimated number of patients enrolled at the end of the study is 2500. Data collection will include preoperative characteristics, intraoperative and postoperative outcomes, patient-reported measures using validated tools as well as complications. Descriptive and advanced statistical analyses, such as uni- and multivariate analyses, will be performed as appropriate depending on the variable examined. RESULTS The results of this study could lay the groundwork for subsequent randomized and comparative studies on larger cohorts, further strengthening the evidence supporting TPLA as a valuable option for LUTS due to BPO. CONCLUSIONS This multicenter prospective registry aims to provide robust real-world data on the effectiveness, safety, and predictors of success for TPLA in the management of BPO. By generating comprehensive data across multiple centers, the study seeks to address current knowledge gaps and support the integration of TPLA into clinical practice guidelines, paving the way for future high-level comparative research. CLINICALTRIAL The study has been approved by the local Ethical Committee in July 2024 (CEAVC25691) and it has been registered on ClinicalTrials.gov (NCT06564415).