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NCT07289243
Treatment for Benign Prostatic Obstruction: Transperineal Laser Ablation
Conditions: RANDOMIZED
Sex: Male
Ages: 40 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Location: UOC Urologia e Trapianti di Rene Policlinico di Bari Bari ITALY/Bari
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 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.
Source: ClinicalTrials.gov (NCT07289243). StuddyBuddy aggregates publicly available trial information.
