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Recruiting NCT07289243

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

No phase Interventional RANDOMIZED

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ECHOLASER-TPLA, TURP.
Who it may be relevant to
Registry conditions: RANDOMIZED. Basic parameters: 40 years — 85 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • IS TO SHOW THE NON-INFERIORITY OF TPLA VERSUS TURP BY IPSS-SCORE [Time frame: one, three, six, twelve mounth after treatment]
Secondary outcome measures (2)
  • COMPARE Q-MAX UROFLOW [Time frame: one, three, six, twelve mounth after treatment]
  • COMPARE INPATIENT-TIMING [Time frame: one, three, six, twelve mounth after treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Italy · 2 centers
  • UOC Urologia e Trapianti di Rene Policlinico di Bari — Bari
  • UOC Urologia e Trapianti di Rene Policlinico di Bari — Bari

Identifiers

NCT: NCT07289243 · TPLA-2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗