Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)

July 25, 2008 updated by: Lawson Health Research Institute

A Prospective Randomized Clinical Trial of Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)

This study will prospectively evaluate a new electrosurgical procedure (bipolar transurethral prostatectomy) in men with symptomatic benign prostatic hyperplasia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to demonstrate that the Bipolar TURP using the Vista Controlled Tissue Resection System is safe and efficacious as a surgical treatment for men with symptomatic BPH, allowing a reduction in the post-operative hospitalization. It is expected that bipolar TURP will be safe and efficacious for the surgical treatment of BPH and will allow a < 24 hour post-operative hospital stay in > 50% of patients undergoing this procedure.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 4

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5H 4B9
        • Alberta Urology Institute Research Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3J5
        • Prostate Centre at Vancouver General Hospital
      • Victoria, British Columbia, Canada, V8R 6T9
        • Can-Med Clinical Research Inc
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1T8
        • Hamilton District Urology Associaton
      • Kingston, Ontario, Canada, K7L 3J7
        • Centre for Advanced Urological Research at Queen's University
      • London, Ontario, Canada, N6A 4V2
        • Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London

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

46 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Symptomatic benign prostatic hyperplasia including patients with acute urinary retention;
  • Peak urinary flow rate < 12 ml/sec;
  • American Urological Association (AUA) symptom score > 12.

Exclusion Criteria:

  • Previous open or transurethral prostatic surgery;
  • History of urethral stricture;
  • Failure to discontinue alpha-adrenergic blocking agents for at least 14 days prior to surgery;
  • Failure to discontinue 5-alpha reductase inhibitor for at least 1 month prior to surgery;
  • Patient interested in future fertility;
  • Patient with known neurogenic bladder dysfunction;
  • Untreated urinary tract infection;
  • American Society of Anesthesiologist (ASA) Class >III;
  • Patients requiring anticoagulation with Coumadin or Heparin;
  • Patient unable or unwilling to comply with follow-up schedule.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Bipolar Electrosurgical Unit
Procedure: Bipolar Transurethral Resection of the Prostate
Bipolar TURP
Other Names:
  • Vista, Bipolar TURP
Active Comparator: 1
Monopolar Electrosurgical Unit
Procedure: Monopolar Transurethral Resection of the Prostate
Monopolar TURP
Other Names:
  • Monopolar TURP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of efficacy will be determined by comparing pre and post-operative symptom scores.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pre and post-operative objective and subjective data for each treatment group will be assessed to determine safety and efficacy. Complications related to the surgical procedure will be noted by flexible cystoscopy at 6 months.
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Lawson Health Research Institute

Collaborators

Gyrus ACMI, Inc.

Investigators

  • Principal Investigator: Hassan Razvi, MD, FRCSC, Urology, St. Joseph's Hospital, University of Western Ontario

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

May 1, 2004

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

July 29, 2008

Last Update Submitted That Met QC Criteria

July 25, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-04-533

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.

Clinical Trials on Benign Prostatic Hyperplasia

Clinical Trials on Bipolar Transurethral Resection of the Prostate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe