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Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)

Primary Purpose

BPH, Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Bipolar Transurethral Resection of the Prostate
Monopolar Transurethral Resection of the Prostate
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BPH focused on measuring Transurethral Resection of Prostate, TURP

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Alberta Urology Institute Research Centre
  • Prostate Centre at Vancouver General Hospital
  • Can-Med Clinical Research Inc
  • Hamilton District Urology Associaton
  • Centre for Advanced Urological Research at Queen's University
  • Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

2

1

Arm Description

Bipolar Electrosurgical Unit

Monopolar Electrosurgical Unit

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 13, 2005
Last Updated
July 25, 2008
Sponsor
Lawson Health Research Institute
Collaborators
Gyrus ACMI, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00199550
Brief Title
Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)
Official Title
A Prospective Randomized Clinical Trial of Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lawson Health Research Institute
Collaborators
Gyrus ACMI, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPH, Benign Prostatic Hyperplasia
Keywords
Transurethral Resection of Prostate, TURP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Description
Bipolar Electrosurgical Unit
Arm Title
1
Arm Type
Active Comparator
Arm Description
Monopolar Electrosurgical Unit
Intervention Type
Procedure
Intervention Name(s)
Bipolar Transurethral Resection of the Prostate
Other Intervention Name(s)
Vista, Bipolar TURP
Intervention Description
Bipolar TURP
Intervention Type
Procedure
Intervention Name(s)
Monopolar Transurethral Resection of the Prostate
Other Intervention Name(s)
Monopolar TURP
Intervention Description
Monopolar TURP
Primary Outcome Measure Information:
Title
Evaluation of efficacy will be determined by comparing pre and post-operative symptom scores.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Razvi, MD, FRCSC
Organizational Affiliation
Urology, St. Joseph's Hospital, University of Western Ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Urology Institute Research Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 4B9
Country
Canada
Facility Name
Prostate Centre at Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3J5
Country
Canada
Facility Name
Can-Med Clinical Research Inc
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6T9
Country
Canada
Facility Name
Hamilton District Urology Associaton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1T8
Country
Canada
Facility Name
Centre for Advanced Urological Research at Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3J7
Country
Canada
Facility Name
Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

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Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)

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