Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy

Study Overview
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Brief Summary
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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
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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).

Official Title
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Transurethral Bipolar Enucleation and Resection of the Prostate Versus Open Prostatectomy for the Treatment of Benign Prostatic Hyperplasia

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Procedure: transurethral bipolar enucleation and resection of the prostate
* Procedure: open surgical transvesical prostatectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: transurethral bipolar enucleation and resection of the prostate<br>transurethral bipolar enucleation and resection of the prostate | Procedure: transurethral bipolar enucleation and resection of the prostate<br>* transurethral bipolar enucleation and resection of the prostate<br>* Other names: TUVERP;|
| Active Comparator: open prostatectomy<br>open surgical transvesical prostatectomy | Procedure: open surgical transvesical prostatectomy<br>* open surgical transvesical prostatectomy<br>* Other names: Transvesical prostatectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | To measure the difference between the two procedure regarding operative time measured in minutes. | Three months | 
| recovery outcome | To measure the difference between the two procedure regarding mean hospital stays measured in days and catheterization period measured in days | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peri-operative complication | 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. | Three months | 
| weight of resected prostatic tissues | to measure the difference between the two procedures regarding weight of resected prostatic tissues Measured in gram | Three months | 
| post-operative International Prostate Symptom Score (IPSS) score. | 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 | Three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transurethral enucleation, Transurethral enucleation and resection of the prostate, plasma enucleation, prostate enucleation, Open Prostatectomy, BPH, Benign prostatic hyperplasia