European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Obstruction (BPO)

University of Florence1 site in 1 country2,500 target enrollmentJanuary 11, 2024

ConditionsBenign Prostatic Hyperplasia Prostatic Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Benign Prostatic Hyperplasia
Sponsor: University of Florence
Enrollment: 2500
Locations: 1
Primary Endpoint: Rate of partecipants needing for other surgery
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 11, 2024

End Date

January 2034

Last Updated

last year

Study Type

Observational

Sex

Male

Investigators

Sponsor

University of Florence

Responsible Party

Principal Investigator

Francesco Sessa

Principal Investigator

University of Florence

Eligibility Criteria

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

Outcomes

Primary Outcomes

Rate of partecipants needing for other surgery

Time Frame: 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 Outcomes

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