NCT06564415 European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms
| NCT ID | NCT06564415 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florence |
| Condition | Benign Prostatic Hyperplasia |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2024-01-11 |
| Primary Completion | 2034-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2024-01-11 with a primary completion date of 2034-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06564415 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Benign Prostatic Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06564415 currently recruiting?
Yes, NCT06564415 is actively recruiting participants. Contact the research team at francesco_sessa@hotmail.it for enrollment information.
Where is the NCT06564415 trial being conducted?
This trial is being conducted at Florence, Italy.
Who is sponsoring the NCT06564415 clinical trial?
NCT06564415 is sponsored by University of Florence. The trial plans to enroll 2,500 participants.