Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)

This study has been completed.
Sponsor:
Collaborator:
GyrusACMI
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00199550
First received: September 13, 2005
Last updated: July 25, 2008
Last verified: July 2008
  Purpose

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


Condition Intervention Phase
BPH
Benign Prostatic Hyperplasia
Procedure: Bipolar Transurethral Resection of the Prostate
Procedure: Monopolar Transurethral Resection of the Prostate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Clinical Trial of Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Evaluation of efficacy will be determined by comparing pre and post-operative symptom scores. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 43
Study Start Date: May 2004
Study Completion Date: June 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Bipolar Electrosurgical Unit
Procedure: Bipolar Transurethral Resection of the Prostate
Bipolar TURP
Other Name: Vista, Bipolar TURP
Active Comparator: 1
Monopolar Electrosurgical Unit
Procedure: Monopolar Transurethral Resection of the Prostate
Monopolar TURP
Other Name: Monopolar TURP

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199550

Locations
Canada, Alberta
Alberta Urology Institute Research Centre
Edmonton, Alberta, Canada, T5H 4B9
Canada, British Columbia
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 3J5
Can-Med Clinical Research Inc
Victoria, British Columbia, Canada, V8R 6T9
Canada, Ontario
Hamilton District Urology Associaton
Hamilton, Ontario, Canada, L8N 1T8
Centre for Advanced Urological Research at Queen's University
Kingston, Ontario, Canada, K7L 3J7
Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
GyrusACMI
Investigators
Principal Investigator: Hassan Razvi, MD, FRCSC Urology, St. Joseph's Hospital, University of Western Ontario
  More Information

No publications provided

Responsible Party: Dr. Hassan Razvi, The University of Western Ontario
ClinicalTrials.gov Identifier: NCT00199550     History of Changes
Other Study ID Numbers: R-04-533
Study First Received: September 13, 2005
Last Updated: July 25, 2008
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
Transurethral Resection of Prostate
TURP

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014