Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)

Phase 4

Completed

• Conditions: BPH; Benign Prostatic Hyperplasia

• Registration Number: NCT00199550
• Lead Sponsor: Lawson Health Research Institute

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, 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 Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2008-03
• Study Completion: 2008-06
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-25
• Last Update Posted: 2008-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of efficacy will be determined by comparing pre and post-operative symptom scores.	6 months

Secondary Outcome Measures

Name	Time	Method
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.	6 months

Trial Locations

Locations (6)

Alberta Urology Institute Research Centre; 🇨🇦 Edmonton, Alberta, Canada

Prostate Centre at Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Can-Med Clinical Research Inc; 🇨🇦 Victoria, British Columbia, Canada

Hamilton District Urology Associaton; 🇨🇦 Hamilton, Ontario, Canada

Centre for Advanced Urological Research at Queen's University; 🇨🇦 Kingston, Ontario, Canada

Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London; 🇨🇦 London, Ontario, Canada