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Clinical Trials/NCT04471155
NCT04471155
Completed
Not Applicable

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

Ain Shams University1 site in 1 country110 target enrollmentApril 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Benign Prostatic Hyperplasia
Sponsor
Ain Shams University
Enrollment
110
Locations
1
Primary Endpoint
efficacy in american urological association symptom score
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
April 22, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

mohamed alnoomani

mohamed nabil alnoomani, assistant lecturer of urology

Ain Shams University

Eligibility Criteria

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

Outcomes

Primary Outcomes

efficacy in american urological association symptom score

Time Frame: 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

Time Frame: 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

Time Frame: 1 year

change of post-voiding residual urine volume in millilitre

Secondary Outcomes

  • safety by doing blood picture to asses hemoglobin drop(immediate post-operative)

Study Sites (1)

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