RecruitingNot ApplicableNCT07289243

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


Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Enrollment

80 participants

Start Date

Jul 14, 2024

Study Type

INTERVENTIONAL

Summary

THIS STUDY IS A 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. THE PRIMARY GOAL IS TO SHOW THE NON-INFERIORITY OF TPLA VERSUS TURP BY IPSS-SCORE.


Eligibility

Sex: MALEMin Age: 40 YearsMax Age: 85 Years

Inclusion Criteria1

  • 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 Criteria1

  • 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

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Interventions

PROCEDUREECHOLASER-TPLA

transperineal laser ablation of prostatic adenoma, by transrectal ultrasound guide.

PROCEDURETURP

Transurethral resection of prostate, by uretrocistoscopy approach.


Locations(2)

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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NCT07289243