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Comparative Study Between Safety and Effectiveness of High Versus Low Power HOLEP

Primary Purpose

Benign Prostatic Hyperplasia

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

HOLEP for treating BPH

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring HOLEP, Enucleation, Prostate

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: large prostate indicated for surgical intervention. Exclusion Criteria: prostate cancer recurrent adenomas associated neurologic factors that may affect outcomes (e.g., neurogenic bladder)

Sites / Locations

Urology department - AlAzhar universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

LP-HoLEP

HP-HoLEP.

Arm Description

2J/25Hz setting

2J/50Hz setting

Outcomes

Primary Outcome Measures

Enucleation Efficiency

Enucleated weight/min will be evaluated.

Secondary Outcome Measures

Dysuria will be assessed by dysuria visual analog scale

burning micturation after the procedure. Dysuria will be assessed by dysuria visual analog scale

The complications of both techniques

The complications will be classified according to the modified Clavien classification system.

Full Information

NCT ID

NCT05678452

First Posted

December 24, 2022

Last Updated

January 9, 2023

Sponsor

Al-Azhar University

1. Study Identification

Unique Protocol Identification Number

NCT05678452

Brief Title

Comparative Study Between Safety and Effectiveness of High Versus Low Power HOLEP

Official Title

Comparative Study Between Safety and Efficacy of High Versus Low Power HOLEP in Enucleation of the Prostate; Prospective Randomized Double Blind Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Holmium laser enucleation (HOLEP) has became a standard of treatment of large prostates that indicates surgery. HOLEP is widely used nowadays. Many settings are used but no optimal setting was world wide adopted. The aim of this trial is to assess the Low-power Holmium laser enucleation of the prostate (LP-HoLEP)and compare to high-power (HP-HoLEP) for enucleation efficiency pertaining to the advantages of lower cost and minimal postoperative dysuria, storage symptoms, and negative sexual impact.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia

Keywords

HOLEP, Enucleation, Prostate

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

HoLEP will be performed using 100W Versapulse, Luminis Inc., with 2J/25Hz for LP-HoLEP and 2J/50Hz for HP-HoLEP.

Masking

None (Open Label)

Masking Description

double blind

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LP-HoLEP

Arm Type

Active Comparator

Arm Description

2J/25Hz setting

Arm Title

HP-HoLEP.

Arm Type

Active Comparator

Arm Description

2J/50Hz setting

Intervention Type

Procedure

Intervention Name(s)

HOLEP for treating BPH

Intervention Description

HoLEP will be performed using 100W Versapulse, Luminis Inc., with 2J/25Hz for LP-HoLEP and 2J/50Hz for HP-HoLEP.

Primary Outcome Measure Information:

Title

Enucleation Efficiency

Description

Enucleated weight/min will be evaluated.

Time Frame

3 hours

Secondary Outcome Measure Information:

Title

Dysuria will be assessed by dysuria visual analog scale

Description

burning micturation after the procedure. Dysuria will be assessed by dysuria visual analog scale

Time Frame

2 weeks

Title

The complications of both techniques

Description

The complications will be classified according to the modified Clavien classification system.

Time Frame

3 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed F Salman, MD

Phone

+201111788996

prof_mohamed_fawzy@yahoo.com

Facility Information:

Facility Name

Urology department - AlAzhar university

City

Cairo

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohamed F Salman, MD

Phone

+201111788996

Prof_mohamed_fawzy@yahoo.com

First Name & Middle Initial & Last Name & Degree

Mohamed F Salman, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Comparative Study Between Safety and Effectiveness of High Versus Low Power HOLEP

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