European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms
NCT Number: NCT06564415
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Benign Prostatic Hyperplasia|Prostatic Diseases
Interventions: PROCEDURE: Transperineal Laser Ablation of Prostate
Sponsor: University of Florence
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 2500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-11
Completion Date: 2034-01
Locations: AOU Careggi, Florence, 50134, Italy

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.

Primary Outcome Measures: Rate of partecipants needing for other surgery, Mid- and long-term effectiveness of TPLA measured by need and/or time until surgical retreatment for BPO (e.g. Transurethral resection of prostate (TURP), endoscopic enucleation, simple prostatectomy), 5 years
Secondary Outcome Measures: Number of Participants with Treatment-Related Adverse Events according to Clavien-Dindo Scale, Number of Participants with Treatment-Related Adverse Events as Assessed by Clavien-Dindo scale (score from I to V - higher scores mean a worse outcome), 6 months|Number of Participants with Treatment-Related Adverse Events according to Comprehensive Complication Index, Number of Participants with Treatment-Related Adverse Events as Assessed by Comprehensive Complication Index. The Comprehensive Complication Index (CCI) reflects the gravity of the overall complication burden on the patient on a scale from 0 (no complication) to 100 (death), 6 months|Change from Baseline in the International Prostatic Symptoms Score (IPSS), Patient-reported outcome measure about urinary symptoms evaluated by International Prostatic Symptoms Score (IPSS) - values from 0 to 35 (higher scores mean a worse outcome), 5 years|Change from Baseline in the IPSS - Quality of Life score, Patient-reported outcome measure about impact of urinary symptoms on quality of life evaluated by IPSS - Quality of Life (QoL) questionnaire (values from 0 to 6 - higher scores mean a worse outcome), 5 years|Change from Baseline in the International Index of Erectile Function (IIEF-5), Patient-reported outcome measure about erectile function evaluated by International Index of Erectile Function (IIEF-5) - values from 0 to 25 (higher values mean a better outcome), 5 years|Change from Baseline in the Male Sexual Health Questionnaire bother (MSHQ bother), Patient-reported outcome measure about impact of ejaculatory disfunctions in quality of life evaluated by Male Sexual Health Questionnaire bother (MSHQ bother) - values from 0 to 5 (higher scores mean a worse outcome), 5 years|Change from Baseline in the Male Sexual Health Questionnaire 3-items (MSHQ 3-items), Patient-reported outcome measure about ejaculatory function evaluated by Male Sexual Health Questionnaire 3-items (MSHQ 3-items) - values from 0 to 15 (higher scores mean a better outcome), 5 years|Change from Baseline in maximum flow rate (ml/s), Change from Baseline in maximum flow rate (ml/s) evaluated at uroflowmetry, 5 years|Change from Baseline in post void residual volume (ml), Change from Baseline in post void residual volume (ml) evaluated with sovrapubic ultrasound or bladderscan after spontaneous micturition, 5 years