Registry for Transperineal Laser Ablation of Prostate for Urinary Symptoms
European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Obstruction (BPO)
This study is testing how well Transperineal Laser Ablation of the prostate helps men with urinary problems caused by an enlarged prostate and looks at how different patients respond to the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Florence Academic / other |
| Locations | 1 site (Florence) |
| Trial ID | NCT06564415 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the mid- and long-term effectiveness of Transperineal Laser Ablation of Prostate (TPLA) in treating lower urinary tract symptoms (LUTS) caused by benign prostatic obstruction. It will collect data on patient-reported outcomes, flowmetry parameters, and safety from patients undergoing TPLA. The study also seeks to identify differences in patient characteristics across treatment centers and explore optimal indications and limitations of TPLA for LUTS.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with moderate-to-severe LUTS and a prostate volume of at least 30 mL.
Not a fit: Patients with prostate cancer, bladder contractility issues, urethral stenosis, or those who have had previous prostate surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for patients suffering from lower urinary tract symptoms due to benign prostatic obstruction.
How similar studies have performed: Other studies have shown promising results with similar laser ablation techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Florence
- AOU Careggi — Florence, Italy (Recruiting)
Study contacts
- Study coordinator: Francesco Sessa
- Email: francesco_sessa@hotmail.it
- Phone: +39 3287305299
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.