Benign Prostatic Hyperplasia
Conditions
Brief summary
comparison of holmium laser enucleation prostatectomy and open prostatectomy regarding safety and efficacy in men with prostate larger than 80 grams
Interventions
PROCEDUREHolep
laser enucleation of the gland versus open enucleation
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
MALE
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy by measuring maximum urinary flow rate in millilitre per second | 1 year | change of maximum urinary flow rate in mililiter per second pre and post opeartive |
| efficacy in american urological association symptom score | 1 year | change of american urological association symptom score pre and post operative by scale from 1 to 35 |
| efficacy of evacuation by measuring post-voiding residual urine volume in millilitre | 1 year | change of post-voiding residual urine volume in millilitre |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety by doing blood picture to asses hemoglobin drop | immediate post-operative | rate of hemoglobin drop post-operatively by gram per decilitre |
Countries
Egypt
Outcome results
None listed