Benign Prostatic Hyperplasia
Conditions
Keywords
Transurethral enucleation, Transurethral enucleation and resection of the prostate, plasma enucleation, prostate enucleation, Open Prostatectomy, BPH, Benign prostatic hyperplasia
Brief summary
Benign prostatic hyperplasia (BPH) is a frequent disease in aging men accompanied by bladder outlet obstruction (BOO). Open prostatectomy (OP) is still considered the first-line treatment for more than 80 ml prostate size. In this study, a mixed technique called transurethral bipolar enucleation and resection of the prostate (TBERP) was compared to the standard open prostatectomy.
Detailed description
Benign prostatic hyperplasia (BPH) is a frequent disease in aging men accompanied by bladder outlet obstruction (BOO). Open prostatectomy (OP) is still considered the first-line treatment for more than 80 ml prostate size. In this study, a mixed technique called transurethral bipolar enucleation and resection of the prostate (TBERP) was compared to the standard open prostatectomy. This is a Comparative, Prospective Study conducted on men over 50 years.The patients were randomly distributed into two groups treated by TBERP and OP. Patients were evaluated preoperatively and at 1-week post catheter removal and 1-3-months postoperatively in terms of blood loss, operation time, the weight of resected prostatic tissues, post-operative catheterisation period, hospital stay, IPSS, PVR, prostate volume, early complications (recatheterization, urine retention, UTI and irritative symptoms) and late complications (urinary incontinence, urethral stricture and bladder neck contracture).
Interventions
PROCEDUREtransurethral bipolar enucleation and resection of the prostate
transurethral bipolar enucleation and resection of the prostate
PROCEDUREopen surgical transvesical prostatectomy
open surgical transvesical prostatectomy
Sponsors
Helwan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In this study, a hybrid technique, that combines two types of techniques using the same cutting current and technological setup, will be proposed enucleation of the prostate gland with the plasma vaporization electrode and resection with a TURis cutting loop. This technique is defined as transurethral vapor enucleation and resection of the prostate (TVERP) comparing it with open prostatectomy.
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male patients * Age more than 50 years * Prostate size of more than 80 ml * IPSS ≥ 8, and maximum urinary flow rate (Qmax) ≤ 15 mL/s * Indications for surgery * Refractory retention (failed ≥1 trial of voiding). * Associated bladder Stones. * Associated recurrent gross Hematuria. * Associated with recurrent Infections. * Associated renal insufficiency. * Bother symptoms refractory to medical treatment.
Exclusion criteria
* Uncorrectable coagulopathy. * Patient with active UTI. * Prostate less than 80 ml. * Severe associated comorbidities. * Previous urethral, prostate, and bladder surgeries, * Patients diagnosed with neurogenic bladder. * Patients diagnosed with prostate cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| operative time | Three months | To measure the difference between the two procedure regarding operative time measured in minutes. |
| recovery outcome | Three months | To measure the difference between the two procedure regarding mean hospital stays measured in days and catheterization period measured in days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| peri-operative complication | Three months | to measure the difference between the two procedures regarding incidence of early complications including re-catheterization, acute urinary retention, early irritative symptoms and urinary tract infections and incidence of late complications Including urinary incontinence, Urethral strictures,and bladder neck contracture. |
| weight of resected prostatic tissues | Three months | to measure the difference between the two procedures regarding weight of resected prostatic tissues Measured in gram |
| post-operative International Prostate Symptom Score (IPSS) score. | Three months | to measure the difference between the two procedures regarding IPSS score. Score 0 to 7 points considered mild symptoms, 8 to 19 points considered moderate symptoms, 20 to 35 points considered severe symptoms |
Countries
Egypt
Outcome results
None listed