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

April 23, 2026 updated by: Ivan Schwartzmann, MD, Fundacio Puigvert

Prospective and Randomized Analysis of Endoscopic Prostate Enucleation Using Moses 2.0 Technology Versus the New Thulium Fiber Laser in Medium and Large Prostates.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Surgery and Follow-up Schedule

  • Surgeries will be performed between September 2024 and September 2025.
  • Initial follow-up at 3 months.
  • Completion of the first phase of the study: March 2026.

Scheduled of Visits: Selection Visit, 1-Month Postoperative Visit, 3-Month Follow-up, 6-Month Follow-up, Annual Follow-up Visit (1-3 years).

Sample size calculation was done using the main outcome variable (total surgical time). Previous studies indicate that surgical time for ThuFLEP is 71.6 minutes [8]. The time for MoLEP may be at least 5 minutes less. Accepting an alpha risk of 5% and a beta risk of 20% in a two-tailed test, a total of 120 patients are needed (60 in each study group). A common standard deviation of 9 minutes change is assumed. A loss to follow-up rate of 15% has been estimated.

Randomization between the two surgery groups will be performed using the Efron procedure to balance the groups in terms of the number of subjects. The calculation will be carried out with the !RndSeq macro for SPSS Statistics. It will be conducted centrally by a person independent of the surgeon.

Statistical Analysis: For quantitative variables, measures of central tendency and dispersion will be .provided. Normality tests will be conducted using the Shapiro-Wilk test. For qualitative variables, valid percentages will be shown. Sociodemographic and clinical data, as well as the main study variables, will be compared between study groups using the Student's t-test (Mann-Whitney U test in case of non-normality). Chi-square test or Fisher's test (if any observed frequency is <5) will be used for qualitative variables. A multivariate linear regression model will be constructed to determine variables related to surgical time. Beta coefficients and 95% confidence intervals (CI) will be determined. A preliminary study will be conducted on potential confounding and interacting factors. Adjustment will be made for clinically or bibliographically relevant variables. Interaction will be tested using the likelihood ratio test. A significant difference will be accepted in all tests with a p-value <0.05. R Studio statistical package (V2.5.1) will be used for data analysis.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • BARCELONA
      • Barcelona, BARCELONA, Spain, 08025
        • Recruiting
        • Fundacio Puigvert
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ivan Schwartzmann Jochamowitz, MD
        • Sub-Investigator:
          • Javier Ponce de León Roca, MD
      • Barcelona, BARCELONA, Spain, 08036
        • Recruiting
        • Clinic Hospital of Barcelona
        • Contact:
          • Javier Sanchez Macià, MD
          • Phone Number: 0034 93 227 54 00
        • Principal Investigator:
          • Maurizio d'Anna, MD
        • Sub-Investigator:
          • Javier Sanchez Macià, MD
        • Contact:
      • L'Hospitalet de Llobregat, BARCELONA, Spain, 08907
        • Recruiting
        • Hospital Univesitari de Bellvitge
        • Contact:
          • Sergi Beato, MD
          • Phone Number: 0034 932 60 75 00
        • Contact:
          • Andreu Alabat, MD
          • Phone Number: 0034 932 60 75 00
        • Principal Investigator:
          • Sergi Beato, MD
        • Sub-Investigator:
          • Andreu Alabat, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males aged between 40 and 90 years.
  • Patients who, due to their lower urinary tract symptoms, are candidates for

BPH surgery, including:

  • Obstructive urinary symptoms evaluated through IPSS with a score >7 and QoL > 2 or acute urinary reten on refractory to catheter removal.

  • Obstructive urinary flow evaluated through uroflowmetry with Qmax< 15 ml/s, obstruction demonstrated by pressure/flow study, prostatic origin haematuria refractory to medical treatment, or acute urinary retention refractory to catheter removal.

    • Prostatic volume measured by transabdominal ultrasound, transrectal ultrasound, or magnetic resonance imaging of more than 80 cc.
    • Prostate-specific antigen (PSA) < 4 ng/ml, or with multiparametric prostate magnetic resonance imaging reporting PIRADS < 3 or equal to 3 with PSA density < 15%.

Exclusion Criteria:

  • 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 superior to 30.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Endoscopic Prostate Enucleation Using Moses 2.0 Technology
Pulse modulation technology in Moses 2.0 applied to Holmium Laser Endoscopic Prostate (MoLEP).
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.
Other Names:
  • Moses 2.0 Technology
Active Comparator: Endoscopic Prostate Enucleation Using the New Thulium Fiber Laser
Thulium Fiber laser to endoscopic prostate enucleation (ThuFLEP).
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.
Other Names:
  • New Thulium Fiber Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SURGICAL TIME
Time Frame: Total time of Surgery procedure
Difference in surgical time between MoLEP and ThuFLEP in prostates larger than 80 cc.
Total time of Surgery procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative bleeding
Time Frame: From date of preoperative blood test to date of control blood test postoperatively within 24 hours after surgery
Differences in perioperative bleeding between MoLEP and ThuFLEP. Difference in haemoglobin level between preoperative blood test and control blood test postoperatively within 24 hours after surgery).
From date of preoperative blood test to date of control blood test postoperatively within 24 hours after surgery
Postoperative hospital stay
Time Frame: From date and time of end of surgery to date and time of hospital discharge assessed up to 1 month
Difference in postoperative hospital stay time between MoLEP and ThuFLEP. Number of days of hospitalization after surgery. Three categories will be recorded: Ambulatory (<16 hours of stay), Less than 24 hours, More than 24 hours (individual length of stay will be recorded).
From date and time of end of surgery to date and time of hospital discharge assessed up to 1 month
Perioperative complications
Time Frame: From date of surgery to date of the end of follow-up 3 years
Difference in the incidence of perioperative complications between MoLEP and ThuFLEP. All possible complications will be recorded and classified according to the Clavien- Dindo scale from date of surgery to end of study.
From date of surgery to date of the end of follow-up 3 years
Urinary symptoms
Time Frame: From date of enrollment to date of the end of follow-up 3 years
Difference in improvement of urinary symptoms after MoLEP compared to ThuFLEP. IPSS questionnaire will be performed in all study visits: Changes in total score and quality of life score before and after surgery will be compared between patients undergoing MoLEP and ThuFLEP.
From date of enrollment to date of the end of follow-up 3 years
Flowmetric variables maximum flow
Time Frame: From date of surgery to date of the end of follow-up 3 years

Difference in improvement of flowmetric values after MoLEP compared to ThuFLEP. Uroflowmetry will be performed at baseline, 3 months, 6 months and annual follow-up visits: Changes in maximum flow measured in ml/s before and after surgery will be compared between patients undergoing MoLEP and ThuFLEP.

A uroflowmetry will be considered valid if the patient reports that it is representative of their current voiding quality and if it presents a voided volume > 150 ml.
From date of surgery to date of the end of follow-up 3 years
Flowmetric variables average flow
Time Frame: From date of surgery to date of the end of follow-up 3 years

Difference in improvement of flowmetric values after MoLEP compared to ThuFLEP. Uroflowmetry will be performed at baseline, 3 months, 6 months and annual follow-up visits: Changes in average flow measured in ml/s before and after surgery will be compared between patients undergoing MoLEP and ThuFLEP.

A uroflowmetry will be considered valid if the patient reports that it is representative of their current voiding quality and if it presents a voided volume > 150 ml.
From date of surgery to date of the end of follow-up 3 years
Flowmetric variables post-void residual
Time Frame: From date of surgery to date of the end of follow-up 3 years

Difference in improvement of flowmetric values after MoLEP compared to ThuFLEP. Uroflowmetry will be performed at baseline, 3 months, 6 months and annual follow-up visits: Changes in post-void residual measured in ml before and after surgery will be compared between patients undergoing MoLEP and ThuFLEP.

A uroflowmetry will be considered valid if the patient reports that it is representative of their current voiding quality and if it presents a voided volume > 150 ml.
From date of surgery to date of the end of follow-up 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio Puigvert

Investigators

  • Principal Investigator: Ivan Schwartzmann Jochamowitz, MD, Fundacio Puigvert

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2024

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 19, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-2024-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A total of two publications with study results will be made, each differing in the follow-up time. A publication of preliminary results will be made when the last patient included in the study has completed the three-month follow-up. A second publication will be made when the last included patient completes two years of follow-up.

IPD Sharing Time Frame

The data will be available when the study results are published.

IPD Sharing Access Criteria

Open

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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