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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Lower urinary tract symptoms (IPSS \>= 8);
* Poor efficacy after at least six months of medical therapy or intolerance to medical treatment for BPH;
* Prostate volume: 40ml-80ml;
* Ability to give informed consent.

Exclusion Criteria:

* Previous surgery for benign prostatic hyperplasia;
* Indwelling bladder catheter or intermittent bladder catheterization;
* Diagnosis of bladder stones;
* Recurrent urinary tract infections or intraprostatic abscesses;
* Severe detrusor hypocontractility or acontractility;
* Hydronefrosis due to urinary retention;
* Urethral strictures or diagnosis of neurogenic bladder;
* Diagnosis of bladder cancer;
* Diagnosis or clinical suspicion of prostate cancer.

Where it's running

• 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
• Email: marcellozingarelli86@gmail.com
• Phone: +393405135446

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.