Application of MOSES Technology in BPH

November 27, 2020 updated by: Hospital Universitari Vall d'Hebron Research Institute

Evaluation of Surgical and Functional Results of the Application of MOSES Technology in the Holmium Laser Prostate Enucleation as a Treatment for Tract Symptoms Lower Urinary Secondary to Benign Prostatic Hyperplasia

In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation using MOSES technology.

Study Type

Interventional

Enrollment (Anticipated)

400

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 Locations

  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Vall D'Hebron University Hospital
        • Contact:
          • Adrià Piñero, MD
        • Principal Investigator:
          • Jose Placer Santos, PhD
        • Sub-Investigator:
          • Alonso Narváez Barros, PhD
        • Sub-Investigator:
          • Enric Miret Alomar, MD
        • Sub-Investigator:
          • Juan Morote Robles, PhD
        • Sub-Investigator:
          • Adrià Piñero Zomeño, 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

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Prostatic volume between 70-200cc
  • Acceptance to participate in the study.

Exclusion Criteria:

  • Previous urethra stricture
  • Previous prostate surgery
  • Neurogenic bladder
  • Bladder tumor
  • Neurological disease with repercussion in the lower urinary tract.
  • Severe psychiatric illness
  • Inability of the patient to consent

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: HoLEP
Conventional laser
Device: Moses technology
Using Holmium laser with Moses technology or conventional one
EXPERIMENTAL: m-HoLEP
Moses technology
Device: Moses technology
Using Holmium laser with Moses technology or conventional one

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin
Time Frame: 24 hours after the surgery
Hemoglobin change
24 hours after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enucleation time
Time Frame: during the surgery
Enucleation time change
during the surgery
Hemostasis time
Time Frame: during the surgery
Hemostasis time change
during the surgery
Morcellating time
Time Frame: during the surgery
Morcellating time change
during the surgery
Surgery time
Time Frame: during the surgery
Surgery time change
during the surgery
Irrigated volume of serum
Time Frame: during the surgery
Irrigated volume of serum change
during the surgery
complication rate
Time Frame: one month after the surgery
difference of complication rate
one month after the surgery
urinary tract infection
Time Frame: one month after the surgery
urinary tract infection rate differences
one month after the surgery
lower urinary tract symptoms
Time Frame: through study completion, an average of 3 years
lower urinary tract symptoms rate differences
through study completion, an average of 3 years
sexual function
Time Frame: through study completion, an average of 3 years
sexual function differences
through study completion, an average of 3 years

Collaborators and Investigators

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

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: José Placer Santos, PhD, Vall D'Hebron University Hospital

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)

March 6, 2020

Primary Completion (ANTICIPATED)

June 30, 2022

Study Completion (ANTICIPATED)

June 30, 2023

Study Registration Dates

First Submitted

March 6, 2020

First Submitted That Met QC Criteria

November 27, 2020

First Posted (ACTUAL)

December 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2020

Last Update Submitted That Met QC Criteria

November 27, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)501/2019

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

product manufactured in and exported from the U.S.

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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