Application of MOSES Technology in BPH

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04648176
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 39.8
• Patients Per Site Per Month: 10.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia (BPH); Lower Urinary Tract Symptoms	Device: Moses technology	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 6, 2020
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: HoLEP Conventional laser	Device: Moses technology; Using Holmium laser with Moses technology or conventional one
Experimental: m-HoLEP Moses technology	Device: Moses technology; Using Holmium laser with Moses technology or conventional one

Outcome Measures

Primary Outcome Measures

1. Hemoglobin [24 hours after the surgery]

   Hemoglobin change

Secondary Outcome Measures

1. Enucleation time [during the surgery]

   Enucleation time change

2. Hemostasis time [during the surgery]

   Hemostasis time change

3. Morcellating time [during the surgery]

   Morcellating time change

4. Surgery time [during the surgery]

   Surgery time change

5. Irrigated volume of serum [during the surgery]

   Irrigated volume of serum change

6. complication rate [one month after the surgery]

   difference of complication rate

7. urinary tract infection [one month after the surgery]

   urinary tract infection rate differences

8. lower urinary tract symptoms [through study completion, an average of 3 years]

   lower urinary tract symptoms rate differences

9. sexual function [through study completion, an average of 3 years]

   sexual function differences

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vall d'Hebron University Hospital	Barcelona		Spain	08035

Sponsors and Collaborators

• Hospital Universitari Vall d'Hebron Research Institute

Investigators

• Principal Investigator: José Placer Santos, PhD, Vall d'Hebrón University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
• ClinicalTrials.gov Identifier: NCT04648176
• Other Study ID Numbers: PR(AG)501/2019
• First Posted: Dec 1, 2020
• Last Update Posted: Dec 1, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Hospital Universitari Vall d'Hebron Research Institute: laser; Holmium; HoLEP; Moses
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms

Study Results

No Results Posted as of Dec 1, 2020