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Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)

NCT ID: NCT00199550

Last Updated: 2008-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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BPH Benign Prostatic Hyperplasia

Keywords

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Transurethral Resection of Prostate TURP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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2

Bipolar Electrosurgical Unit

Group Type ACTIVE_COMPARATOR

Bipolar Transurethral Resection of the Prostate

Intervention Type PROCEDURE

Bipolar TURP

1

Monopolar Electrosurgical Unit

Group Type ACTIVE_COMPARATOR

Monopolar Transurethral Resection of the Prostate

Intervention Type PROCEDURE

Monopolar TURP

Interventions

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Bipolar Transurethral Resection of the Prostate

Bipolar TURP

Intervention Type PROCEDURE

Monopolar Transurethral Resection of the Prostate

Monopolar TURP

Intervention Type PROCEDURE

Other Intervention Names

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Vista, Bipolar TURP Monopolar TURP

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Gyrus ACMI, Inc.

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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The University of Western Ontario

Principal Investigators

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Hassan Razvi, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Urology, St. Joseph's Hospital, University of Western Ontario

Locations

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Alberta Urology Institute Research Centre

Edmonton, Alberta, Canada

Site Status

Prostate Centre at Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Can-Med Clinical Research Inc

Victoria, British Columbia, Canada

Site Status

Hamilton District Urology Associaton

Hamilton, Ontario, Canada

Site Status

Centre for Advanced Urological Research at Queen's University

Kingston, Ontario, Canada

Site Status

Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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R-04-533

Identifier Type: -

Identifier Source: org_study_id