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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

NCT ID: NCT07289243

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-14

Study Completion Date

2026-12-25

Brief Summary

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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.

Detailed Description

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Conditions

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RANDOMIZED

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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TPLA

Patients underwent TPLA tretment

Group Type OTHER

ECHOLASER-TPLA

Intervention Type PROCEDURE

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

TURP

Patients underwent TURP tretment

Group Type OTHER

TURP

Intervention Type PROCEDURE

Transurethral resection of prostate, by uretrocistoscopy approach.

Interventions

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ECHOLASER-TPLA

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

Intervention Type PROCEDURE

TURP

Transurethral resection of prostate, by uretrocistoscopy approach.

Intervention Type PROCEDURE

Other Intervention Names

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TPLA

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

OTHER

Sponsor Role lead

Responsible Party

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Pasquale Ditonno

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UOC Urologia e Trapianti di Rene Policlinico di Bari

Bari, ITALY/Bari, Italy

Site Status RECRUITING

UOC Urologia e Trapianti di Rene Policlinico di Bari

Bari, ITALY/Bari, Italy

Site Status ACTIVE_NOT_RECRUITING

Countries

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Italy

Central Contacts

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Marcello MZ Zingarelli, medicine and surgery

Role: CONTACT

Phone: +393405135446

Email: [email protected]

Facility Contacts

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Pasquale PD Ditonno, medicine and surgery

Role: primary

Other Identifiers

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TPLA-2023

Identifier Type: -

Identifier Source: org_study_id