Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)

Last updated: July 25, 2008
Sponsor: Lawson Health Research Institute
Overall Status: Completed

Phase

4

Condition

Benign Prostatic Hyperplasia (Enlarged Prostate)

Bladder Disorders

Prostate Disorders

Treatment

N/A

Clinical Study ID

NCT00199550
R-04-533
  • Ages 50-85
  • Male

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Symptomatic benign prostatic hyperplasia including patients with acute urinaryretention;

  • Peak urinary flow rate < 12 ml/sec;

  • American Urological Association (AUA) symptom score > 12.

Exclusion

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 tosurgery;

  • Failure to discontinue 5-alpha reductase inhibitor for at least 1 month prior tosurgery;

  • 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 Design

Total Participants: 43
Study Start date:
May 01, 2004
Estimated Completion Date:
June 30, 2008

Study 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.

Connect with a study center

  • Alberta Urology Institute Research Centre

    Edmonton, Alberta T5H 4B9
    Canada

    Site Not Available

  • Prostate Centre at Vancouver General Hospital

    Vancouver, British Columbia V5Z 3J5
    Canada

    Site Not Available

  • Can-Med Clinical Research Inc

    Victoria, British Columbia V8R 6T9
    Canada

    Site Not Available

  • Hamilton District Urology Associaton

    Hamilton, Ontario L8N 1T8
    Canada

    Site Not Available

  • Centre for Advanced Urological Research at Queen's University

    Kingston, Ontario K7L 3J7
    Canada

    Site Not Available

  • Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London

    London, Ontario N6A 4V2
    Canada

    Site Not Available

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