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

NCT ID: NCT05678452

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

NONE

double blind

Study Groups

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LP-HoLEP

2J/25Hz setting

Group Type ACTIVE_COMPARATOR

HOLEP for treating BPH

Intervention Type PROCEDURE

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

HP-HoLEP.

2J/50Hz setting

Group Type ACTIVE_COMPARATOR

HOLEP for treating BPH

Intervention Type PROCEDURE

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

Interventions

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HOLEP for treating BPH

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Fawzy Abd Elfattah Salman

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Urology department - AlAzhar university

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed F Salman, MD

Role: CONTACT

+201111788996

Facility Contacts

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Mohamed F Salman, MD

Role: primary

+201111788996

Other Identifiers

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low and high power HOLEP

Identifier Type: -

Identifier Source: org_study_id

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