Comparison of Holmium Laser Enucleation Prostatectomy and Open Transvesical Prostatectomy in Large Prostate

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Procedure: Holep

• Registration Number: NCT04471155
• Lead Sponsor: Ain Shams University

Brief Summary

comparison of holmium laser enucleation prostatectomy and open prostatectomy regarding safety and efficacy in men with prostate larger than 80 grams

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-22
• Status Verified: 2020-07
• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-13
• Last Update Submitted: 2020-07-13
• Study First Posted: 2020-07-15
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 110

Inclusion Criteria

• American Urological Association Symptom Score of eight or higher,
• Maximum urinary flow rate of 10ml/s or less,
• Post void residual urine volume of 50 ml or more,
• And a total prostate volume of 80 ml or more in transrectal ultrasound (TRUS).

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Exclusion Criteria

• A previous prostate or urethral surgery
• And non-BPH related voiding disorders
• Prostate cancer patients

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Holep	Holep	patient underwent laser prostatectomy
open prostatectomy	Holep	patient underwent open prostatectomy

Primary Outcome Measures

Name	Time	Method
efficacy in american urological association symptom score	1 year	change of american urological association symptom score pre and post operative by scale from 1 to 35
efficacy by measuring maximum urinary flow rate in millilitre per second	1 year	change of maximum urinary flow rate in mililiter per second pre and post opeartive
efficacy of evacuation by measuring post-voiding residual urine volume in millilitre	1 year	change of post-voiding residual urine volume in millilitre

Secondary Outcome Measures

Name	Time	Method
safety by doing blood picture to asses hemoglobin drop	immediate post-operative	rate of hemoglobin drop post-operatively by gram per decilitre

Trial Locations

Locations (1)

Mohamed Alnoomani; 🇪🇬 Cairo, القاهرة, Egypt