European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorUniversity of Florence
About this trial
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
Qualifiers
Age ≥18 years;
Prostate volume ≥ 30 mL;
Moderate-to-severe LUTS according to International Prostatic Symptoms Score (IPSS ≥8)
Consent to participate;
Disqualifiers
Absence of consent;
Subsequent withdrawal of consent;
Diagnosis or suspicion of prostate cancer at multiparametric magnetic resonance
Documented bladder impaired contractility
Trial design
Treatments tested in this trial
- Transperineal Laser Ablation of Prostate
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov