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

Comparison of Holmium Laser Enucleation Prostatectomy and Open Transvesical Prostatectomy in Large Prostate More Than 80 Grams in Egyptian Men

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

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Procedure: Holep

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • القاهرة
    • Cairo, القاهرة, Egypt
      • Mohamed Alnoomani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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).

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Holep; patient underwent laser prostatectomy	Procedure: Holep; laser enucleation of the gland versus open enucleation; Other Names: open prostatectomy
Active Comparator: open prostatectomy; patient underwent open prostatectomy	Procedure: Holep; laser enucleation of the gland versus open enucleation; Other Names: open prostatectomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety by doing blood picture to asses hemoglobin drop	rate of hemoglobin drop post-operatively by gram per decilitre	immediate post-operative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 22, 2020

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: MD/152/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No