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

January 9, 2023 updated by: Mohamed Fawzy Abd Elfattah Salman, Al-Azhar University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Urology department - AlAzhar university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LP-HoLEP
2J/25Hz setting
Procedure: 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.
Active Comparator: HP-HoLEP.
2J/50Hz setting
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enucleation Efficiency
Time Frame: 3 hours
Enucleated weight/min will be evaluated.
3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysuria will be assessed by dysuria visual analog scale
Time Frame: 2 weeks
burning micturation after the procedure. Dysuria will be assessed by dysuria visual analog scale
2 weeks
The complications of both techniques
Time Frame: 3 months
The complications will be classified according to the modified Clavien classification system.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

December 24, 2022

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Estimate)

January 10, 2023

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • low and high power HOLEP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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