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

Not Applicable
Recruiting
Conditions
Benign Prostatic Hyperplasia
Interventions
Procedure: HOLEP for treating BPH
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

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
Arm && Interventions
GroupInterventionDescription
LP-HoLEPHOLEP for treating BPH2J/25Hz setting
HP-HoLEP.HOLEP for treating BPH2J/50Hz setting
Primary Outcome Measures
NameTimeMethod
Enucleation Efficiency3 hours

Enucleated weight/min will be evaluated.

Secondary Outcome Measures
NameTimeMethod
The complications of both techniques3 months

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

Dysuria will be assessed by dysuria visual analog scale2 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

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