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RECRUITING Not applicable ClinicalTrials.gov

Treatment for Benign Prostatic Obstruction: Transperineal Laser Ablation

Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari • ClinicalTrials.gov ID: NCT07289243

Registry updated: 2026-09-17
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Description

THIS STUDY IS A RANDOMIZED CLINICAL TRIAL COMPARING TRANSURETHRAL PROSTATE RESECTION (TURP) AND ECHOLASER SORACTELITE-TRANSPERINEAL LASER ABLATION (TPLA) IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC OBSTRUCTION. THE PRIMARY GOAL IS TO SHOW THE NON-INFERIORITY OF TPLA VERSUS TURP BY IPSS-SCORE.

Interventions

  • ECHOLASER-TPLA (Procedure)
    transperineal laser ablation of prostatic adenoma, by transrectal ultrasound guide.
  • TURP (Procedure)
    Transurethral resection of prostate, by uretrocistoscopy approach.

Eligibility criteria

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.

Conditions

RANDOMIZED

Locations

  • UOC Urologia e Trapianti di Rene Policlinico di Bari — Bari, ITALY/Bari, Italy
  • UOC Urologia e Trapianti di Rene Policlinico di Bari — Bari, ITALY/Bari, Italy
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record