Clinical trial NCT06564415: European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms
Official title: European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Obstruction (BPO)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Benign Prostatic Hyperplasia
Prostatic Diseases
Keywords: TPLA
Transperineal Laser Ablation
LUTS
BPH
Benign Prostatic Obstruction
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 2500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred to the centers participating in the study

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.


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

Primary outcomes:
measure: Rate of partecipants needing for other surgery
timeFrame: 5 years
Secondary outcomes:
measure: Number of Participants with Treatment-Related Adverse Events according to Clavien-Dindo Scale
timeFrame: 6 months
measure: Number of Participants with Treatment-Related Adverse Events according to Comprehensive Complication Index
timeFrame: 6 months
measure: Change from Baseline in the International Prostatic Symptoms Score (IPSS)
timeFrame: 5 years
measure: Change from Baseline in the IPSS - Quality of Life score
timeFrame: 5 years
measure: Change from Baseline in the International Index of Erectile Function (IIEF-5)
timeFrame: 5 years
measure: Change from Baseline in the Male Sexual Health Questionnaire bother (MSHQ bother)
timeFrame: 5 years
measure: Change from Baseline in the Male Sexual Health Questionnaire 3-items (MSHQ 3-items)
timeFrame: 5 years
measure: Change from Baseline in maximum flow rate (ml/s)
timeFrame: 5 years
measure: Change from Baseline in post void residual volume (ml)
timeFrame: 5 years
Other outcomes:
Locations:
city: Florence
country: Italy
facility: AOU Careggi
Study officials:
References:
citation: Sessa F, Polverino P, Siena G, Bisegna C, Lo Re M, Spatafora P, Pecoraro A, Rivetti A, Moscardi L, Saladino M, Cocci A, Gacci M, Li Marzi V, Carini M, Minervini A, Campi R, Serni S. Transperineal Laser Ablation of the Prostate (TPLA) for Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction. J Clin Med. 2023 Jan 19;12(3):793. doi: 10.3390/jcm12030793.
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