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NCT05678452 Clinical Trial

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

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05678452
Other study ID # low and high power HOLEP
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date September 1, 2024

Study information
Verified date December 2022
Source Al-Azhar University
Contact Mohamed F Salman, MD
Phone +201111788996
Email prof_mohamed_fawzy@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date September 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender Male
Age group 45 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Egypt Urology department - AlAzhar university Cairo

Sponsors (1)
Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Enucleation Efficiency Enucleated weight/min will be evaluated. 3 hours
Secondary Dysuria will be assessed by dysuria visual analog scale burning micturation after the procedure. Dysuria will be assessed by dysuria visual analog scale 2 weeks
Secondary The complications of both techniques The complications will be classified according to the modified Clavien classification system. 3 months
See also
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