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NCT Number: NCT04848181

The Effect of Pre-operative Use of Finasteride Versus Cyproterone Acetate on Blood Loss With Transurethral Resection of Prostate

Perioperative bleeding is the most common complication related to transurethral resection of prostate, the aim of the study is to compare the effect of pre-operative use of finasteride versus Cyproterone acetate on blood loss with mono polar TURP

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Key information

Conditions

Prostate Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Benha University

Banhā, Qalyubia Governorate, 15311, Egypt

About this study

This prospective randomized controlled study to compare the effect of pre-operative use of finasteride versus Cyproterone acetate on blood loss with mono polar TURP

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with benign prostatic hyperplasia with prostate size (60-100) grams
  • Lower urinary tract symptoms (LUTS) not responding to medical treatment
  • Recurrent prostatic bleeding
  • Recurrent acute urinary retention
  • Chronic urinary retention

Exclusion criteria

  • Patients with coagulation disorders
  • Previous prostatic surgery
  • Previous finasteride administration
  • Bladder pathology (urinary bladder stones - bladder mass)
  • Suspected or proved cancer prostate
  • Hepatic or renal impairment
  • Patients unfit for operation eg. Decompensated heart failure, poor chest condition

Treatment and study plan

cyproterone acetate

Drug

two weeks Cyproterone acetate administration before TURP

finasteride

Drug

two weeks finasteride administration before TURP

no treatment received

Drug

no treatment received before TURP

Primary outcomes

  1. post operative Hb

    Time frame: 24 hour post operative

    measuring serum haemoglobin level at first post operative

  2. post operative Hcv

    Time frame: 24 hour post operative

    measuring serum haematocrit value at first post operative

  3. operative duration

    Time frame: immediately after surgery

    assessment of the duration of the operation

  4. microvascular density(MVD)

    Time frame: 2 weeks after drug intake

    assesment of MVD of the prostate by histological examination using high power field microscope

  5. intraoperative blood loss

    Time frame: immediately after surgery

    assessment of intraoperative blood loss during TURP

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

The Effect of Short Term Use of Finasteride Versus Cyproterone Acetate on Perioperative Blood Loss With Mono Polar Transurethral Resection of Prostate

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 19, 2021
Registry last updated
Jul 21, 2021

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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