Actively Recruiting
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
Eligibility Criteria
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%
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here