Application of MOSES Technology in BPH

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms

Intervention / Treatment
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* Device: Moses technology


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HoLEP<br>Conventional laser | Device: Moses technology<br>* Using Holmium laser with Moses technology or conventional one<br>|
| Experimental: m-HoLEP<br>Moses technology | Device: Moses technology<br>* Using Holmium laser with Moses technology or conventional one<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser, Holmium, HoLEP, Moses