Actively Recruiting

Phase Not Applicable
Age: 40Years - 90Years
MALE
NCT06565741

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

Led by Fundacio Puigvert · Updated on 2026-04-29

120

Participants Needed

3

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 40Years - 90Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 40 to 90 years
  • Candidates for BPH surgery due to lower urinary tract symptoms
  • Obstructive urinary symptoms with IPSS score greater than 7 and quality of life score greater than 2, or acute urinary retention refractory to catheter removal
  • Obstructive urinary flow with Qmax less than 15 ml/s, obstruction shown by pressure/flow study, prostatic origin hematuria refractory to medical treatment, or acute urinary retention refractory to catheter removal
  • Prostate volume over 80 cc measured by transabdominal ultrasound, transrectal ultrasound, or MRI
  • PSA less than 4 ng/ml, or multiparametric prostate MRI with PIRADS less than 3 or equal to 3 with PSA density less than 15%
Not Eligible

You will not qualify if you...

  • Diagnosis, suspicion, or history of urethral stenosis or urethral surgery
  • History of prostate surgery or pelvic radiotherapy
  • Diagnosis or suspicion of prostate cancer or urothelial cancer
  • Body mass index greater than 30

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Trial Site Locations

Total: 3 locations

1

Fundacio Puigvert

Barcelona, BARCELONA, Spain, 08025

Actively Recruiting

2

Clinic Hospital of Barcelona

Barcelona, BARCELONA, Spain, 08036

Actively Recruiting

3

Hospital Univesitari de Bellvitge

L'Hospitalet de Llobregat, BARCELONA, Spain, 08907

Actively Recruiting

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Research Team

I

Ivan Schwartzmann Jochamowitz, MD

CONTACT

S

Silvia Mateu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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