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

A

Ain Shams University

Status

Completed

Conditions

Benign Prostatic Hyperplasia

Treatments

Procedure: Holep

Study type

Interventional

Funder types

Other

Identifiers

NCT04471155
MD/152/2018

Details and patient eligibility

About

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

Enrollment

110 patients

Sex

Male

Ages

55+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

110 participants in 2 patient groups

Holep
Active Comparator group
Description:
patient underwent laser prostatectomy
Treatment:
Procedure: Holep
open prostatectomy
Active Comparator group
Description:
patient underwent open prostatectomy
Treatment:
Procedure: Holep

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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