Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy

Helwan University64 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Benign Prostatic Hyperplasia

Interventions

transurethral bipolar enucleation and resection of the prostatePROCEDURE

transurethral bipolar enucleation and resection of the prostate

open surgical transvesical prostatectomyPROCEDURE

open surgical transvesical prostatectomy

Eligibility

Sex: MALEMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Helwan university faculty of medicine

Helwan, Egypt

Outcomes

Primary Outcomes

operative time

To measure the difference between the two procedure regarding operative time measured in minutes.

Time frame: 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

Time frame: Three months

Secondary Outcomes

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.

Time frame: Three months

weight of resected prostatic tissues

to measure the difference between the two procedures regarding weight of resected prostatic tissues Measured in gram

Time frame: 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

Time frame: Three months

Data from ClinicalTrials.gov

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