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Application of MOSES Technology in BPH

Primary Purpose

Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Moses technology
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH) focused on measuring laser, Holmium, HoLEP, Moses

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Vall d'Hebron University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

HoLEP

m-HoLEP

Arm Description

Conventional laser

Moses technology

Outcomes

Primary Outcome Measures

Hemoglobin
Hemoglobin change

Secondary Outcome Measures

Enucleation time
Enucleation time change
Hemostasis time
Hemostasis time change
Morcellating time
Morcellating time change
Surgery time
Surgery time change
Irrigated volume of serum
Irrigated volume of serum change
complication rate
difference of complication rate
urinary tract infection
urinary tract infection rate differences
lower urinary tract symptoms
lower urinary tract symptoms rate differences
sexual function
sexual function differences

Full Information

First Posted
March 6, 2020
Last Updated
November 27, 2020
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04648176
Brief Title
Application of MOSES Technology in BPH
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 6, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms
Keywords
laser, Holmium, HoLEP, Moses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HoLEP
Arm Type
Active Comparator
Arm Description
Conventional laser
Arm Title
m-HoLEP
Arm Type
Experimental
Arm Description
Moses technology
Intervention Type
Device
Intervention Name(s)
Moses technology
Intervention Description
Using Holmium laser with Moses technology or conventional one
Primary Outcome Measure Information:
Title
Hemoglobin
Description
Hemoglobin change
Time Frame
24 hours after the surgery
Secondary Outcome Measure Information:
Title
Enucleation time
Description
Enucleation time change
Time Frame
during the surgery
Title
Hemostasis time
Description
Hemostasis time change
Time Frame
during the surgery
Title
Morcellating time
Description
Morcellating time change
Time Frame
during the surgery
Title
Surgery time
Description
Surgery time change
Time Frame
during the surgery
Title
Irrigated volume of serum
Description
Irrigated volume of serum change
Time Frame
during the surgery
Title
complication rate
Description
difference of complication rate
Time Frame
one month after the surgery
Title
urinary tract infection
Description
urinary tract infection rate differences
Time Frame
one month after the surgery
Title
lower urinary tract symptoms
Description
lower urinary tract symptoms rate differences
Time Frame
through study completion, an average of 3 years
Title
sexual function
Description
sexual function differences
Time Frame
through study completion, an average of 3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adrià Piñero Zomeño, MD
Phone
934893000
Ext
6370
Email
adria.pinero@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Placer Santos, PhD
Organizational Affiliation
Vall d'Hebrón University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vall d'Hebron University Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrià Piñero, MD
First Name & Middle Initial & Last Name & Degree
Jose Placer Santos, PhD
First Name & Middle Initial & Last Name & Degree
Alonso Narváez Barros, PhD
First Name & Middle Initial & Last Name & Degree
Enric Miret Alomar, MD
First Name & Middle Initial & Last Name & Degree
Juan Morote Robles, PhD
First Name & Middle Initial & Last Name & Degree
Adrià Piñero Zomeño, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Application of MOSES Technology in BPH

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