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OpenTrials
Completed

NCT Number: NCT04471155

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

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

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

55 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed Alnoomani

Cairo, Cairo Governorate, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Holep

Procedure

laser enucleation of the gland versus open enucleation

Other names: open prostatectomy

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. safety by doing blood picture to asses hemoglobin drop

    Time frame: immediate post-operative

    rate of hemoglobin drop post-operatively by gram per decilitre

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 15, 2020
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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