Application of MOSES Technology in BPH

Not Applicable

• Conditions: Benign Prostatic Hyperplasia (BPH); Lower Urinary Tract Symptoms
• Interventions: Device: Moses technology

• Registration Number: NCT04648176
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Timeline

• Study Start: 2020-03-06
• Study First Submitted: 2020-03-06
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-27
• Last Update Submitted: 2020-11-27
• Study First Posted: 2020-12-01
• Last Update Posted: 2020-12-01
• Primary Completion: 2022-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 400

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HoLEP	Moses technology	Conventional laser
m-HoLEP	Moses technology	Moses technology

Primary Outcome Measures

Name	Time	Method
Hemoglobin	24 hours after the surgery	Hemoglobin change

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vall d'Hebron University Hospital; 🇪🇸 Barcelona, Spain