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Clinical Trials in Italy / NCT07289243
Recruiting Not applicable

Treatment for Benign Prostatic Obstruction: Transperineal Laser Ablation

NCT07289243 · tracked via the Priya Life Science Italy tracker
Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Phase
Not applicable
Started
2024-07-14
Last updated
2026-09-17

Condition(s) studied

RANDOMIZED

Investigational drug(s) / intervention(s)

ECHOLASER-TPLATURP

ECHOLASER-TPLA: transperineal laser ablation of prostatic adenoma, by transrectal ultrasound guide.

TURP: Transurethral resection of prostate, by uretrocistoscopy approach.

Study summary

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.

Eligibility

Sex
MALE
Min age
40 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Symptomatology Improvement by International Prostate Symptoms Score (PSS-SCORE) — one, three, six, twelve months after treatment
    After 3,6 and 12 months of follow-up International Prostate Symptom Score (IPSS) questionnaire will be administered to all participants to evaluate changes in subjective symptoms and quality of life (Lower IPSS values indicate an improvement in the symptoms reported by the patient). The IPSS ranges from 0 to 35, with scores interpreted as follows: 0-7 indicates mild symptoms, 8-19 indicates moderate symptoms, and 20-35 indicates severe symptoms

Trial sites (2)

FacilityCityRegionStatus
UOC Urologia e Trapianti di Rene Policlinico di Bari Bari ITALY/Bari Recruiting
UOC Urologia e Trapianti di Rene Policlinico di Bari Bari ITALY/Bari Active Not Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07289243 on ClinicalTrials.gov ↗ ← All trials in Italy