Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199550
• Other study ID #: R-04-533
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: July 25, 2008
• Start date: May 2004
• Est. completion date: June 2008

Study information

• Verified date: July 2008
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• BPH
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• Bipolar Transurethral Resection of the Prostate
Bipolar TURP
• Monopolar Transurethral Resection of the Prostate
Monopolar TURP

Locations

Country	Name	City	State
Canada	Alberta Urology Institute Research Centre	Edmonton	Alberta
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	Prostate Centre at Vancouver General Hospital	Vancouver	British Columbia
Canada	Can-Med Clinical Research Inc	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	GyrusACMI

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of efficacy will be determined by comparing pre and post-operative symptom scores.		6 months	No
Secondary	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	Yes