EEAP Using Moses 2.0 Technology vs the Thulium Fiber Laser in Medium-Large Prostates

Summary

Introduction: Endoscopic anatomical enucleation of the prostate (EEAP) with lasers has emerged as an effective and less invasive surgical option compared to traditional methods. Among the various available laser options, Holmium laser and Thulium Fiber laser have stood out as two prominent approaches for performing endoscopic prostate enucleation. These technologies have 3 showcased their effectiveness in ablating prostatic tissue and improving urinary symptoms. Nevertheless, differences in their physical properties and modes of action may impact their success rates and clinical outcomes. In our institution it is standard practice to use one laser or the other according to their availability in the operating room.

Primary Objective: To demonstrate the superiority of MoLEP over ThuFLEP in terms of enucleation efficiency.

Secondary Objectives: a) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of perioperative bleeding.

b) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of postoperative hospital stay.

c) To demonstrate the non-inferiority of ThuFLEP compared to ThuFLEP in terms of perioperative complications.

d) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in urinary symptoms.

e) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in flowmetric variables.

Study Type: Prospective, randomized, non-blind, multicentric clinical trial. Intervention: Patients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or ThuFLEP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50 cases) and possessing experience with both laser types, will perform the surgical procedure.

Conditions

• Prostatic Hyperplasia
• Surgery
• Endoscopic Anatomical Enucleation of the Prostate (EEAP)

Interventions

PROCEDURE

MoLEP

Patients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or ThuFLEP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50 cases) and possessing experience with both laser types, will perform the surgical procedure.

PROCEDURE

ThuFLEP

Patients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or ThuFLEP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50 cases) and possessing experience with both laser types, will perform the surgical procedure.

Sponsors & Collaborators

• Fundacio Puigvert

  lead OTHER

Principal Investigators

• Ivan Schwartzmann Jochamowitz, MD · Fundacio Puigvert

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

90 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-03

Primary Completion

2028-09-30

Completion

2028-09-30

Countries

• Spain

Study Locations