Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate

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

Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate. A Prospective Randomized Multicentric Study

Introduction: Multiple studies have demonstrated the superiority of HoLEP in aspects such as transfusión rates or postoperative stay. On the other hand, no differences have been observed in terms of functional outcomes between both techniques, and surgical times reported in different studies tend to be longer for HoLEP. These results likely contribute to TURP, especially with bipolar energy (Bi-TURP), continuing to be considered by many the gold standard for surgical treatment of BPH.

Sofware and hardware upgrades to the Lumenis Pulse 120H. system in 2017, delivered MOSES 2.0, a single-use laser fibre used to perform MOSES augmented HoLEP (MoLEP). MoLEP has shown to be superior in intraoperative outcomes when compared to traditional HoLEP. The availability of new morcellators might also decrease surgical time for HoLEP. This changing landscape for BPH endoscopic surgery deserves a re-evaluation of the differences between Bi-TURP and MoLEP.

Primary Objective: To compare the hospital stay of patients of patients undergoing MoLEP with those undergoing Bi-TURP.

Secondary objectives:

  • To compare the surgical time of MoLEP with that of Bi-TURP.
  • To compare the bladder catheterization time aCer MoLEP with that of Bi-TURP.
  • To compare the postoperative complication rate patients undergoing MoLEP with those undergoing Bi-TURP.
  • To compare functional results of patients undergoing MoLEP with those undergoing Bi-TURP.

This study is a prospective multicentric randomized and controlled trial. The study compares two types of BPH surgery without changing standard medical practice.

The study will include patients who are candidates according to standard medical practice for BPH surgery. Patients will be randomized to one of two groups of treatment.

  • The MoLEP group will receive surgical treatment with MoLEP.
  • The Bi-TURP group will receive surgical treatment with Bi-TURP. Surgical technique and postoperative care will follow standard clinical practice at each participating centre.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction: The evolution of surgery for benign prostatic hyperplasia (BPH) has come a long way since Freyer described his technique of open adenomectomy over 100 years ago. The advancement of instruments and surgical techniques has made surgery increasingly les invasive. Transurethral resection of the prostate (TURP) allowed endoscopic treatment of BPH and it is still regarded by many as the gold-standard for BPH surgical treatment. The application of Holmium laser for endoscopic enucleation of the prostate (HoLEP) in the last 20 years has allowed for the surgical treatment of BPH through an endoscopic approach, practically without limitations in prostate size.

Multiple studies have demonstrated the superiority of HoLEP in aspects such as transfusión rates or postoperative stay. On the other hand, no differences have been observed in terms of functional outcomes between both techniques, and surgical times reported in different studies tend to be longer for HoLEP. These results likely contribute to TURP, especially with bipolar energy (Bi-TURP) continuing to be considered by many the gold standard for surgical treatment of BPH.

However, the available studies often have short follow-up periods, most do not report on the surgeon's experience with HoLEP, and were based on early laser and morcellation technology. Sofware and hardware upgrades to the Lumenis Pulse 120H system in 2017, delivered MOSES 2.0, a single-use laser fibre used to perform MOSES augmented HoLEP (MoLEP). MoLEP has shown to be superior in intraoperative outcomes when compared to traditional HoLEP, resulting in shorter enucleation, haemostasis, and total surgical times for similar energy delivered. The availability of new morcellators might also decrease surgical time for HoLEP. This changing landscape for BPH endoscopic surgery deserves a re-evaluation of the differences between Bi-TURP and MoLEP.

Hypothesis: MoLEP surgery is superior to Bi-TURP in terms of postoperative stay, bladder catheter duration, blood loss and transfusion rate, without significant functional outcomes, and retreatment rate, with no significant differences in surgical time.

Objectives:

Primary Objective: To compare the hospital stay of patients of patients undergoing MoLEP with those undergoing Bi-TURP.

Secondary objectives:

  • To compare the surgical time of MoLEP with that of Bi-TURP.
  • To compare the bladder catheterization time aCer MoLEP with that of Bi-TURP.
  • To compare the postoperative complication rate patients undergoing MoLEP with those undergoing Bi-TURP.
  • To compare functional results of patients undergoing MoLEP with those undergoing Bi-TURP.

Study Design: This study is a prospective multicentric randomized and controlled trial. The study compares two types of BPH surgery without changing standard medical practice. The CONSORT guidelines for randomized clinical trials will be followed.

Participants: Patients who are candidates according to standard medical practice for BPH surgery with a prostate volume ≤ 80 cc measured by urological ultrasound or magnetic resonance imaging (MRI).

Intervention: The study will include patients who are candidates according to standard medical practice for BPH surgery. Patients will be randomized to one of two groups of treatment.

  • The MoLEP group will receive surgical treatment with MoLEP.
  • The Bi-TURP group will receive surgical treatment with Bi-TURP. Surgical technique and postoperative care will follow standard clinical practice at each participating centre.

Surgery and Follow-up Schedule:

  • Surgeries will be conducted between November 2024 and April 2025
  • Initial 6-month follow-up. Database construction and refinement: 2 months. Statistical analysis: 2 months. Preparation of the final report: 2 months. Completion of the first phase of the study: April 2026.
  • Second phase follow-up: 24 months. Database construction and refinement: 2 months. Statistical analysis: 2 months. Preparation of the final report: 2 months. Dissemination of results: 2 months. Completion of the second phase of the study: October 2027
  • Third phase follow-up: 5 years. Database construction and refinement: 2 months. Statistical analysis: 2 months. Preparation of the final report: 2 months. Dissemination of results: 2 months. Completion of the third phase of the study: October 2030.

Sample size calculation was calculated based on length of hospital stay. Previous studies indicate that the mean days of hospital stay is around 2,5 days in patients with RTU. The length of hospital stay for patients with MoLEP may be at least 1 day less. Around 10% of patients are treated with antiplatelet agents. In order to perform an analysis according to patients with and without this treatment, the sample size will be increased by 10%. Accepting an alpha risk of 5% and a beta risk of 20% in a two-tailed test, a total of 130 patients are needed (65 in each study group). A common standard deviation of 1 day is assumed. A loss to follow-up rate of 12% has been also estimated.

Statistical Analysis: Qualitative variables will be described with absolute frequencies and percentages. The description of quantitative variables will be performed using the mean, standard deviation (SD), median and quartiles. The Kolmogorov-Smirnov test will be used to assess the normality of distributions.

An initial bivariate intention to treat analysis will be performed in order to analyze potential differences according study groups. The relationship between two qualitative variables will be calculated using the chi-squared test or Fisher's exact test (frequency <5). Quantitative variables will be compared using the Student's t-test (Mann Whitney. For non-normal distributions), analysis of variance [ANOVA] (> 2 categories), linear regression test and Schea's multiple comparisons test. The linear relationship between the quantitative variables will be calculated using Pearson's correlation coefficient or Spearman's rank correlation test (when variable not normally distributed). Changes at the end of follow up in the main outcomes will be analyzed by Wilcoxon nonparametric test in the case of quantitative variables. The McNemar test will be used for the comparison of categorical variables. A backward stepwise linear regression analysis will be performed in order to determine which factors are independently associated to higher length of hospital stay. Study groups and variables with a p value <0.2 in the univariate analysis will be included as independent variables. The results will be described with beta coefficient , 95% confidence interval (CI) and p-values. For all the tests, p-values < 0.05 were considered statistically significant. The statistical package R Studio (V2.5.1) was used for the analyses.

Publications will be made with the results of the study, whether they are positive or negative. There will be at least 3 publication scheduled. This will be the results at 6 months, 2 years, and 5 years of follow up.

Study Type

Interventional

Enrollment (Estimated)

130

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
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Recruiting
        • Complejo Hospitalario Universitario de Santiago de Compostela
        • Contact:
        • Contact:
          • Lucía Mosquera, MD
          • Phone Number: 0034 981 95 00 00
        • Sub-Investigator:
          • Lucía Mosquera, MD
        • Principal Investigator:
          • Daniel Adolfo Pérez Fentes, MD
    • BARCELONA
      • Barcelona, BARCELONA, Spain, 08025
        • Recruiting
        • Fundacio Puigvert
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ivan Schwartzmann Jochamowitz, MD
        • Sub-Investigator:
          • Javier Ponce de León, MD
      • L'Hospitalet de Llobregat, BARCELONA, Spain, 08907
        • Not yet recruiting
        • Hospital Univesitari de Bellvitge
        • Contact:
          • Sergi Beato, MD
          • Phone Number: 0034 932 60 75 00
        • Contact:
        • Principal Investigator:
          • Andreu Alabat Roca, MD
        • Sub-Investigator:
          • Sergi Beato, MD
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecillas
        • Contact:
        • Principal Investigator:
          • Ester Fernández, MD
    • Principality of Asturias
      • Gijón, Principality of Asturias, Spain, 33394
        • Recruiting
        • Hospital Universitario de Cabueñes
        • Contact:
        • Principal Investigator:
          • Rebeca Blanco Fernández, MD
    • Valladolid
      • Valladolid, Valladolid, Spain, 47012
        • Recruiting
        • Hospital Universitario Rio Hortega
        • Contact:
          • Alejandro García Viña, MD
          • Phone Number: 0034 983 42 04 00
          • Email: ax_gv@hotmail.com
        • Principal Investigator:
          • Alejandro García Viña, 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with maximum flow rate < 15 ml/sec before obstructive surgery or with maximum flow rate > 15 ml/sec and urodynamic study showing high-flow obstruction defined as bladder outlet obstruction index > 40.
  • Patients with moderate to severe lower urinary tract symptoms (LUTS) according to the International Prostate Symptom Score (IPSS). Score between 8 and 35.
  • Patients with a prostate volume between 40 and 80 cc, measured by urological ultrasound or MRI.

Exclusion Criteria:

  • History of prior prostatic obstructive or urethral surgery.
  • Diagnosis of prostate neoplasia.
  • Diagnosis of urothelial neoplasia.
  • Lack of flowmetry or IPSS data before surgery.
  • Diagnosis or suspicion of hypo/acontractile detrusor before prostatic obstructive surgery.
  • Diagnosis or suspicion of neurogenic bladder or neurological disease.
  • History of pelvic radiation therapy.

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: MoLEP
Endoscopic Prostate Enucleation Using Moses 2.0 Technology Pulse modulation technology in Moses 2.0applied to Holmium Laser Endoscopic Prostate (MoLEP).
Device: 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 BiTURP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50cases) and possessing experience with both laser types, will perform the surgical procedure.
Active Comparator: BiTURP
Bipolar Transurethral Resection of the Prostate
Device: BiTURP
Patients with an indication for surgery for BPH viaEEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or BiTURP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50cases) and possessing experience with both laser types, will perform the surgical procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Variation in length of hospital stay after each procedure. Difference in postoperative hospital stay time between MoLEP and BiTURP. Number of hours in the hospital after the procedure if finished, organized in the following categories: Outpatient procedure (less than 16 hours), 1 day of hospitalization (≤ 24 hours), 2 days of hospitalization (≤ 48 hours), 3 days of hospitalization (≤ 72 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SURGICAL TIME
Time Frame: Total time of Surgery procedure
Difference in surgical time between MoLEP and BiTURP in prostates larger than 80 cc.
Total time of Surgery procedure
The bladder catheterization time
Time Frame: Total time of bladder catheterization procedure
Difference in the bladder catheterization time after MoLEP with that of Bi-TURP
Total time of bladder catheterization procedure
Perioperative complications
Time Frame: From date of surgery to date of the end of follow-up 5 years
Difference in the incidence of perioperative complications between MoLEP and ThuFLEP. All possible complications will berecorded and classifi ed 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 5 years
TREATMENT
Time Frame: From date of surgery to date of the end of follow-up 5 years
Variation in treatment efficacy between groups. Difference in improvement after MoLEP compared to BiTURP
From date of surgery to date of the end of follow-up 5 years
Urinary symptoms
Time Frame: From date of enrollment to date of the end of follow-up 5 years
Incidence of additional treatment requirement for lower urinary tract symptoms after the treatment. Difference in improvement of urinary symptoms after MoLEP compared to BiTRUP. 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 BiTURP.
From date of enrollment to date of the end of follow-up 5 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)

April 1, 2025

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2030

Study Registration Dates

First Submitted

October 17, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 18, 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

  • C2024 35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Publications will be made with the results of the study, whether they are positive or negative. There will be at least 3 publications scheduled. This will be the results at 6 months, 2 years, and 5 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

Yes

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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