Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)

NCT00199550 | Completed Phase 4

• 1 other identifier: R-04-533
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

BPH; Benign Prostatic Hyperplasia

Keywords

Transurethral Resection of Prostate; TURP

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

• 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

Study Arms (2)

2

ACTIVE COMPARATOR

Bipolar Electrosurgical Unit

Procedure: Bipolar Transurethral Resection of the Prostate

1

ACTIVE COMPARATOR

Monopolar Electrosurgical Unit

Procedure: Monopolar Transurethral Resection of the Prostate

Interventions

Bipolar Transurethral Resection of the Prostate PROCEDURE

Bipolar TURP

Also known as: Vista, Bipolar TURP

2

Monopolar Transurethral Resection of the Prostate PROCEDURE

Monopolar TURP

Also known as: Monopolar TURP

1

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic benign prostatic hyperplasia including patients with acute urinary retention;
• Peak urinary flow rate \< 12 ml/sec;
• American Urological Association (AUA) symptom score \> 12.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Gyrus ACMI, Inc.: collaborator

Study Sites (6)

Alberta Urology Institute Research Centre

Edmonton, Alberta, T5H 4B9, Canada

Location

Prostate Centre at Vancouver General Hospital

Vancouver, British Columbia, V5Z 3J5, Canada

Location

Can-Med Clinical Research Inc

Victoria, British Columbia, V8R 6T9, Canada

Location

Hamilton District Urology Associaton

Hamilton, Ontario, L8N 1T8, Canada

Location

Centre for Advanced Urological Research at Queen's University

Kingston, Ontario, K7L 3J7, Canada

Location

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

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Hassan Razvi, MD, FRCSC

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: May 1, 2004
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 29, 2008

Record last verified: 2008-07

Locations

CA (6)