Outpatient Holmium LASER Enucleation of the Prostate: Benefit of MOSES(TM) 2.0 Technology (MOSES)

June 24, 2025 updated by: University Hospital, Bordeaux

To Compare the Effectiveness of the MOSES 2.0 Technology to the Non-MOSES Technology on the Success Rate of Holmium LASER Enucleation of the Prostate (HoLEP) Performed on an Outpatient Basis in the Context of Benign Prostatic Hypertrophy.

The aim of this study is to compare the success rate of outpatient surgery after holmium LASER enucleation of the prostate (HoLEP) for the treatment of BPH with and without the use of the MOSES 2.0 effect.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

HoLEP is in the process of becoming the new reference surgical treatment for BPH with the main advantages over monopolar transurethral resection (TURPm) and high approach adenomectomy (AVH): the significant reduction in morbidity perioperative period and therefore the reduction in the length of hospital stay. This reduction in length of stay has led to the development of outpatient care with encouraging results. The main cause of discharge failure on D0 is the persistence of postoperative hematuria requiring maintenance of bladder irrigation. MOSESTM 2.0 technology has the advantage of better hemostasis compared to the LASER LP100 currently used. The objective of this study is to evaluate the influence of MOSESTM 2.0 technology on the outpatient success rate in patients operated on for HoLEP for BPH.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France, 33075
        • CHU de Bordeaux

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  • Patients who require HoLEP for Begnign Prostate Hypertrophy eligible for outpatient management
  • Patients having been managed by HoLEP (without MOSES 2.0) in ambulatory care since January 2016 in the urology department of the Bordeaux University Hospital.

Description

Inclusion Criteria:

  • Subject over 50 years old
  • BPH whose symptoms require surgical management
  • Preoperative prostate volume measured by ultrasound (suprapubic or transrectal) ≥ 40g
  • IPSS score > 15 and Quality of Life score ≥ 3
  • Maximum urinary output (Qmax) < 15 ml/sec

Exclusion Criteria:

  • Inability to read or write French
  • Patients with comorbidities contraindicating general anesthesia
  • Patients not eligible for outpatient care according to French recommendations (high risk of complications after general anesthesia, place of residence more than 150 km from an emergency department, alone at home the night following the intervention) .
  • History of BPH surgery
  • History of prostate cancer
  • Preoperative prostate volume measured by ultrasound (suprapubic or transrectal) < 40g
  • Existence or history of urethral stricture
  • Existence or suspicion of a "neurological" bladder
  • Positive preoperative cytobacteriological examination not treated appropriately
  • Adult patients subject to a legal protection measure or unable to express their consent
  • Patients deprived of liberty by a judicial or administrative decision or hospitalized without consent or admitted to a health or social establishment for purposes other than research

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
HoLEP patients without MOSESTM 2.0 effect (open label)
control retrospective open label
Procedure: HoLEP patients without MOSES(TM) 2.0 effect (open label)
HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, without using MOSES technology
HoLEP patients with MOSESTM 2.0 effect (open label)
prospective open label
Procedure: HoLEP patients with MOSES(TM) 2.0 effect (open label)
HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, with the use of MOSES technology

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of patient who discharge on D0 (same day of his surgery)
Time Frame: baseline
baseline
Number of hour's hospitalization
Time Frame: baseline
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Intraoperative transfusion rate
Time Frame: baseline
baseline
Duration of post-operative sounding (hours)
Time Frame: baseline
baseline
Readmission rate within 48 hours of discharge from hospital
Time Frame: baseline
baseline
Mean change in IPSS before surgery and 3 months after surgery
Time Frame: 3 months after surgery
3 months after surgery
Mean change in QoL before surgery and 3 months after surgery
Time Frame: 3 months after surgery
3 months after surgery
Mean change in IIEF-5 before surgery and 3 months after surgery
Time Frame: 3 months after surgery
3 months after surgery
Mean change in ICIQ-short form score before surgery and 3 months after surgery
Time Frame: 3 months after surgery
3 months after surgery
Mean change in USP before surgery and 3 months after surgery
Time Frame: 3 months after surgery
3 months after surgery
Mean evolution of Qmax and post-void residual (RPM) before the intervention and at 3 months post-operative
Time Frame: 3 months after surgery
3 months after surgery
Number of hour's surgery time
Time Frame: baseline
baseline
Rate of enucleated prostate tissue By time treatment per patient
Time Frame: baseline
baseline
number of minutes use of the LASER during surgery
Time Frame: baseline
baseline
quantity of energy used during the intervention per patient
Time Frame: baseline
baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Grégoire ROBERT, PU-PH, University Hospital Bordeaux, France

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX2022/48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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