Registry for Transperineal Laser Ablation of Prostate for Urinary Symptoms
Official title: European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Obstruction (BPO)
Run by University of Florence · NCT06564415 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 2500 (estimated) |
| Sponsor | University of Florence Academic / other |
| Locations | 1 site (Florence) |
| Status | Recruiting |
| Started | January 11, 2024 |
| Main results expected | January 2034 |
| Study ends | January 2034 |
| Registry record updated | August 21, 2024 |
| Trial ID | NCT06564415 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include men aged 18 and older with moderate-to-severe LUTS and a prostate volume of at least 30 mL.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results with similar laser ablation techniques, indicating potential for success in this approach.
Who can join: the full rules
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 it's running
-
AOU Careggi
Florence, Italy Recruiting
Study contacts
- Study coordinator: Francesco Sessa
- Email: francesco_sessa@hotmail.it
- Phone: +39 3287305299
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Tamsulosin With or Without Tadalafil for a Trial Without Catheter After Acute Urinary Retention
This study tests whether adding tadalafil to tamsulosin helps men with a first episode of acute urinary retention due to enlarged prostate pass urine without needing a catheter.
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Tamsulosin dose change or switch to silodosin before catheter removal in men with BPH-related acute urinary retention
This trial tests whether continuing tamsulosin, increasing its dose, or switching to silodosin helps men with BPH-related acute urinary retention go without a catheter after seven days.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.