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

NCT06565741 | Recruiting DMC

• 1 other identifier: C-2024-23
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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)

Keywords

Medium and Large Prostates; Endoscopic Prostate Enucleation; Endoscopic anatomical enucleation of the prostate (EEAP); Holmium laser; Thulium Fiber laser; Moses 2.0 Technology

Outcome Measures

Primary Outcomes (1)

• SURGICAL TIME

  Difference in surgical time between MoLEP and ThuFLEP in prostates larger than 80 cc.

  Total time of Surgery procedure

Secondary Outcomes (7)

• Perioperative bleeding

  From date of preoperative blood test to date of control blood test postoperatively within 24 hours after surgery

• Postoperative hospital stay

  From date and time of end of surgery to date and time of hospital discharge assessed up to 1 month

• Perioperative complications

  From date of surgery to date of the end of follow-up 3 years

• Urinary symptoms

  From date of enrollment to date of the end of follow-up 3 years

• Flowmetric variables maximum flow

  From date of surgery to date of the end of follow-up 3 years

Study Arms (2)

Endoscopic Prostate Enucleation Using Moses 2.0 Technology

ACTIVE COMPARATOR

Pulse modulation technology in Moses 2.0 applied to Holmium Laser Endoscopic Prostate (MoLEP).

Procedure: MoLEP

Endoscopic Prostate Enucleation Using the New Thulium Fiber Laser

ACTIVE COMPARATOR

Thulium Fiber laser to endoscopic prostate enucleation (ThuFLEP).

Procedure: ThuFLEP

Interventions

MoLEP PROCEDURE

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.

Also known as: Moses 2.0 Technology

Endoscopic Prostate Enucleation Using Moses 2.0 Technology

ThuFLEP PROCEDURE

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.

Also known as: New Thulium Fiber Laser

Endoscopic Prostate Enucleation Using the New Thulium Fiber Laser

Eligibility Criteria

• Age: 40 Years - 90 Years
• Gender Eligibility Details: Males with an indication for BPH surgery through EAEP with a prostatic volume \>80cc.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio Puigvert: lead

Study Sites (3)

Fundacio Puigvert

Barcelona, BARCELONA, 08025, Spain

RECRUITING

Clinic Hospital of Barcelona

Barcelona, BARCELONA, 08036, Spain

RECRUITING

Hospital Univesitari de Bellvitge

L'Hospitalet de Llobregat, BARCELONA, 08907, Spain

RECRUITING

Related Publications (7)

• Enikeev D, Glybochko P, Okhunov Z, Alyaev Y, Rapoport L, Tsarichenko D, Enikeev M, Sorokin N, Dymov A, Taratkin M. Retrospective Analysis of Short-Term Outcomes After Monopolar Versus Laser Endoscopic Enucleation of the Prostate: A Single Center Experience. J Endourol. 2018 May;32(5):417-423. doi: 10.1089/end.2017.0898. Epub 2018 Mar 13.

  PMID: 29430969 BACKGROUND

• Nottingham CU, Large T, Agarwal DK, Rivera ME, Krambeck AE. Comparison of Newly Optimized Moses Technology vs Standard Holmium:YAG for Endoscopic Laser Enucleation of the Prostate. J Endourol. 2021 Sep;35(9):1393-1399. doi: 10.1089/end.2020.0996. Epub 2021 Jul 15.

  PMID: 33813861 BACKGROUND

• Wani MM, Sriprasad S, Bhat T, Madaan S. Is Thulium laser enucleation of prostate an alternative to Holmium and TURP surgeries - A systematic review? Turk J Urol. 2020 Nov;46(6):419-426. doi: 10.5152/tud.2020.20202. Epub 2020 Oct 9.

  PMID: 33052829 BACKGROUND

• Fraundorfer MR, Gilling PJ. Holmium:YAG laser enucleation of the prostate combined with mechanical morcellation: preliminary results. Eur Urol. 1998;33(1):69-72. doi: 10.1159/000019535.

  PMID: 9471043 BACKGROUND

• Elmansy H, Hodhod A, Elshafei A, Noureldin YA, Mehrnoush V, Zakaria AS, Hadi RA, Fathy M, Abbas L, Kotb A, Shahrour W. Comparative analysis of MOSESTM technology versus novel thulium fiber laser (TFL) for transurethral enucleation of the prostate: A single-institutional study. Arch Ital Urol Androl. 2022 Jun 29;94(2):180-185. doi: 10.4081/aiua.2022.2.180.

  PMID: 35775343 BACKGROUND

• Zhang Y, Yuan P, Ma D, Gao X, Wei C, Liu Z, Li R, Wang S, Liu J, Liu X. Efficacy and safety of enucleation vs. resection of prostate for treatment of benign prostatic hyperplasia: a meta-analysis of randomized controlled trials. Prostate Cancer Prostatic Dis. 2019 Dec;22(4):493-508. doi: 10.1038/s41391-019-0135-4. Epub 2019 Feb 28.

  PMID: 30816336 BACKGROUND

• Enikeev D, Netsch C, Rapoport L, Gazimiev M, Laukhtina E, Snurnitsyna O, Alekseeva T, Becker B, Taratkin M, Glybochko P. Novel thulium fiber laser for endoscopic enucleation of the prostate: A prospective comparison with conventional transurethral resection of the prostate. Int J Urol. 2019 Dec;26(12):1138-1143. doi: 10.1111/iju.14115. Epub 2019 Sep 22.

  PMID: 31544290 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ivan Schwartzmann Jochamowitz, MD

  Fundacio Puigvert

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan Schwartzmann Jochamowitz, MD

CONTACT

0034934169700; ischwartzm@fundacio-puigvert.es

Silvia Mateu, MD

CONTACT

0034934169700; smateu@fundacio-puigvert.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 22, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be available when the study results are published.
• Access Criteria: Open

Locations

ES (3)