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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

ConditionRANDOMIZED
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-85
SponsorAzienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

age, Lower urinary tract simptoms (IPSS >= 8), uncompliance or no achived drugs treatment for IPB, prostate volume 40ml-80ml , ability to express informed consent.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • ECHOLASER-TPLA

    Procedure/Surgery

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

  • TURP

    Procedure/Surgery

    Transurethral resection of prostate, by uretrocistoscopy approach.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: TPLAOther 1 intervention
Group B: TURPOther 1 intervention

Trial outcomes

Primary outcomes

1

IS TO SHOW THE NON-INFERIORITY OF TPLA VERSUS TURP BY IPSS-SCORE

Time frame
one, three, six, twelve mounth after treatment

Secondary outcomes

1

COMPARE Q-MAX UROFLOW

Time frame
one, three, six, twelve mounth after treatment
2

COMPARE INPATIENT-TIMING

Time frame
one, three, six, twelve mounth after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Lead sponsor

Source ClinicalTrials.gov
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