Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-06-01

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.

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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).

Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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transurethral bipolar enucleation and resection of the prostate

Group Type ACTIVE_COMPARATOR

transurethral bipolar enucleation and resection of the prostate

Intervention Type PROCEDURE

transurethral bipolar enucleation and resection of the prostate

open prostatectomy

open surgical transvesical prostatectomy

Group Type ACTIVE_COMPARATOR

open surgical transvesical prostatectomy

Intervention Type PROCEDURE

open surgical transvesical prostatectomy

Interventions

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transurethral bipolar enucleation and resection of the prostate

Intervention Type PROCEDURE

open surgical transvesical prostatectomy

Intervention Type PROCEDURE

Other Intervention Names

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TUVERP Transvesical prostatectomy

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.

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No