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NCT04648176 Clinical Trial

Application of MOSES Technology in BPH

Lower Urinary Tract Symptoms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04648176
Other study ID # PR(AG)501/2019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 6, 2020
Est. completion date June 30, 2023

Study information
Verified date November 2020
Source Hospital Universitari Vall d'Hebron Research Institute
Contact Adrià Piñero Zomeño, MD
Phone 934893000
Email adria.pinero@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date June 30, 2023
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 100 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Spain Vall d'Hebron University Hospital Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemoglobin Hemoglobin change 24 hours after the surgery
Secondary Enucleation time Enucleation time change during the surgery
Secondary Hemostasis time Hemostasis time change during the surgery
Secondary Morcellating time Morcellating time change during the surgery
Secondary Surgery time Surgery time change during the surgery
Secondary Irrigated volume of serum Irrigated volume of serum change during the surgery
Secondary complication rate difference of complication rate one month after the surgery
Secondary urinary tract infection urinary tract infection rate differences one month after the surgery
Secondary lower urinary tract symptoms lower urinary tract symptoms rate differences through study completion, an average of 3 years
Secondary sexual function sexual function differences through study completion, an average of 3 years
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