Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)

Phase 4CompletedNCT00199550

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's43 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

BPH Benign Prostatic Hyperplasia

Interventions

Bipolar Transurethral Resection of the ProstatePROCEDURE

Bipolar TURP

Monopolar Transurethral Resection of the ProstatePROCEDURE

Monopolar TURP

Eligibility

Sex: MALEMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

Evaluation of efficacy will be determined by comparing pre and post-operative symptom scores.

Time frame: 6 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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