TURP versus EchoLaser transperineal laser ablation (TPLA) for men with urinary symptoms from benign prostate obstruction

RANDOMIZED CLINICAL TRIAL COMPARING TRANSURETHRAL PROSTATE RESECTION (TURP) AND ECHOLASER SORACTELITE-TPLA (TRANSPERINEAL LASER ABLATION) IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC OBSTRUCTION

This will test whether EchoLaser transperineal laser ablation (TPLA) works as well as standard TURP to reduce urinary symptoms in men with an enlarged prostate.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 40 Years to 85 Years
• Sex: Male
• Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari (Academic / other)
• Locations: 2 sites (Bari, ITALY/Bari and 1 other locations)
• Trial ID: NCT07289243 on ClinicalTrials.gov

What this trial studies

This randomized clinical comparison, conducted at Policlinico di Bari, will assign men with lower urinary tract symptoms from benign prostatic obstruction to either standard transurethral resection of the prostate (TURP) or EchoLaser Soractelite transperineal laser ablation (TPLA). Eligible participants have IPSS ≥8, prostate volume 40–80 mL, and have not had successful medical therapy. The primary outcome is non-inferiority of TPLA versus TURP measured by change in IPSS score, with additional outcomes likely to include complications, urinary flow, and recovery metrics. Patients with prior prostate surgery, indwelling catheters, bladder stones or tumors, active infections, urethral strictures, or neurologic bladder dysfunction are excluded.

Who should consider this trial

Good fit: Adult men with bothersome lower urinary tract symptoms due to benign prostatic obstruction, IPSS ≥8, prostate volume 40–80 mL, and who have not achieved symptom control with medical therapy are the ideal candidates.

Not a fit: Patients with prior prostate surgery, indwelling bladder catheters, bladder stones or tumors, active urinary or seminal infections, urethral strictures, or neurologic bladder dysfunction are excluded and unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, TPLA could offer similar symptom relief to TURP with a less invasive approach and potentially faster recovery or fewer procedure-related complications.

How similar studies have performed: Minimally invasive prostate ablation techniques have shown promising symptom improvements in prior work, and small series of transperineal laser ablation report favorable results, but randomized head-to-head evidence versus TURP remains limited.

Eligibility criteria

Inclusion Criteria:

* age, Lower urinary tract simptoms (IPSS \>= 8), uncompliance or no achived drugs treatment for IPB, prostate volume 40ml-80ml , ability to express informed consent.

Exclusion Criteria:

* previous surgical tretment for IPB, bladder catheter, bladder stones, urinary or seminal infections, hypo-/a-contractilitis of bladder, bladder tuomrs, urethral stricture, neurological bladder, refuse to sign informed consent

Where this trial is running

Bari, ITALY/Bari and 1 other locations

• UOC Urologia e Trapianti di Rene Policlinico di Bari — Bari, ITALY/Bari, Italy (Recruiting)
• UOC Urologia e Trapianti di Rene Policlinico di Bari — Bari, ITALY/Bari, Italy (Active_not_recruiting)

Study contacts

• Study coordinator: Marcello MZ Zingarelli, medicine and surgery

Conditions RANDOMIZED