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Transperineal Laser Ablation vs Transurethral Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial

NCT04781049 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2023-02-21

No results posted yet for this study

Summary

The primary objective of the study is to compare Trans-Perineal Laser Ablation of Prostate versus Trans-Urethral Resection of Prostate in the immediate impact on post-operative pain; in terms of relief in benign prostatic obstruction and preservation of the ejaculatory function in the short term (at 1, 3 and 6 months).

The secondary objective of the study is the evaluation of the long-term deobstructive effectiveness (12 months).

Conditions

  • Prostate Hyperplasia
  • Benign Prostatic Hyperplasia
  • Benign Prostatic Hypertrophy
  • Benign Prostatic Hypertrophy With Outflow Obstruction

Interventions

PROCEDURE

Trans-Perineal Laser Ablation of Prostate

TPLA treatment will be performed using the EchoLaser EVO system (Elesta SpA - Calenzano, FI, Italy). EchoLaser EVO consists of four echolasers, a multi-source laser system with a wavelength of 1064nm and Echolaser Smart Interface (ESI), a treatment planning device for safely inserting introductor needles and optical fibers into prostate tissue. EchoLaser therapy is a micro-invasive percutaneous procedure that uses laser light transmitted through applicators (optical fibers) for a few minutes, causing a heating of the affected tissue to its irreversible damage in "situ", without the need to remove it. EchoLaser therapy, through flat-tip fibers, produces an ellipsoidal clotting area (area where the tissue has irreversible damage). EchoLaser therapy will be performed under ultrasound guidance.

PROCEDURE

Trans-Urethral Resection of Prostate

TURP is the gold standard for the treatment of benign prostatic obstruction. It will be performed by using a bipolar energy resectoscope. The procedure will be carried out with patient in a lithotomic position.

Sponsors & Collaborators

  • Elesta S.R.L.

    collaborator INDUSTRY

  • San Carlo di Nancy Hospital

    lead OTHER

Principal Investigators

  • Pierluigi Bove, MD · San Carlo di Nancy Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-09-20
Completion
2022-10-06

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04781049 on ClinicalTrials.gov