Status:
COMPLETED
Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Gyrus ACMI, Inc.
Conditions:
BPH
Benign Prostatic Hyperplasia
Eligibility:
MALE
50-85 years
Phase:
PHASE4
Brief Summary
This study will prospectively evaluate a new electrosurgical procedure (bipolar transurethral prostatectomy) in men with symptomatic benign prostatic hyperplasia.
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, allow...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00199550
Start Date
May 1 2004
End Date
June 1 2008
Last Update
July 29 2008
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Alberta Urology Institute Research Centre
Edmonton, Alberta, Canada, T5H 4B9
2
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 3J5
3
Can-Med Clinical Research Inc
Victoria, British Columbia, Canada, V8R 6T9
4
Hamilton District Urology Associaton
Hamilton, Ontario, Canada, L8N 1T8