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

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status: Enrolling

Conditions: RANDOMIZED

Treatments: Procedure: ECHOLASER-TPLA; Procedure: TURP

Study type: Interventional

Funder types: Other

Identifiers

NCT07289243

TPLA-2023

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Male

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

TPLA

Other group

Description:

Patients underwent TPLA tretment

Treatment:

Procedure: ECHOLASER-TPLA

TURP

Other group

Description:

Patients underwent TURP tretment

Treatment:

Procedure: TURP