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

Recruiting

• Conditions: Prostatic Diseases; Benign Prostatic Hyperplasia

• Registration Number: NCT06564415
• Lead Sponsor: University of Florence

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-11
• Status Verified: 2024-08
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-18
• Last Update Submitted: 2024-08-18
• Study First Posted: 2024-08-21
• Last Update Posted: 2024-08-21
• Primary Completion: 2034-01
• Study Completion: 2034-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 2500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of partecipants needing for other surgery	5 years	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)

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Treatment-Related Adverse Events according to Clavien-Dindo Scale	6 months	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)
Change from Baseline in the Male Sexual Health Questionnaire bother (MSHQ bother)	5 years	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)
Change from Baseline in the International Prostatic Symptoms Score (IPSS)	5 years	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)
Change from Baseline in the International Index of Erectile Function (IIEF-5)	5 years	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)
Change from Baseline in the IPSS - Quality of Life score	5 years	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)
Change from Baseline in maximum flow rate (ml/s)	5 years	Change from Baseline in maximum flow rate (ml/s) evaluated at uroflowmetry
Number of Participants with Treatment-Related Adverse Events according to Comprehensive Complication Index	6 months	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)
Change from Baseline in the Male Sexual Health Questionnaire 3-items (MSHQ 3-items)	5 years	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)
Change from Baseline in post void residual volume (ml)	5 years	Change from Baseline in post void residual volume (ml) evaluated with sovrapubic ultrasound or bladderscan after spontaneous micturition

Trial Locations

Locations (1)

AOU Careggi; 🇮🇹 Florence, Italy