Application of MOSES Technology in BPH

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 30, 2022

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.

Interventions

  • Device: Moses technology
    • Using Holmium laser with Moses technology or conventional one

Arms, Groups and Cohorts

  • Active Comparator: HoLEP
    • Conventional laser
  • Experimental: m-HoLEP
    • Moses technology

Clinical Trial Outcome Measures

Primary Measures

  • Hemoglobin
    • Time Frame: 24 hours after the surgery
    • Hemoglobin change

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Universitari Vall d’Hebron Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • José Placer Santos, PhD, Principal Investigator, Vall d’Hebrón University Hospital
  • Overall Contact(s)
    • Adrià Piñero Zomeño, MD, 934893000, adria.pinero@gmail.com

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