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

Not Applicable

Recruiting

• Conditions: Benign Prostatic Hyperplasia

• Registration Number: NCT05678452
• Lead Sponsor: Al-Azhar University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-12-24
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-06-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Enucleation Efficiency	3 hours	Enucleated weight/min will be evaluated.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Urology department - AlAzhar university; 🇪🇬 Cairo, Egypt