Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy

June 8, 2022 updated by: Mohamed Fawzy Hassan Mahdy Elsyaad, Helwan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Helwan, Egypt, 11731
        • Helwan university faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: transurethral bipolar enucleation and resection of the prostate
Procedure: transurethral bipolar enucleation and resection of the prostate
transurethral bipolar enucleation and resection of the prostate
Other Names:
  • TUVERP
Active Comparator: open prostatectomy
open surgical transvesical prostatectomy
Procedure: open surgical transvesical prostatectomy
open surgical transvesical prostatectomy
Other Names:
  • Transvesical prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: Three months
To measure the difference between the two procedure regarding operative time measured in minutes.
Three months
recovery outcome
Time Frame: Three months
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
Time Frame: 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.
Three months
weight of resected prostatic tissues
Time Frame: Three months
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.
Time Frame: 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
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helwan University

Investigators

  • Study Director: Tarek Salem, professor, Helwan university faculty of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

June 5, 2022

First Submitted That Met QC Criteria

June 8, 2022

First Posted (Actual)

June 13, 2022

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 8, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 51-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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