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Completed

NCT Number: NCT00199550

Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)

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

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Key information

Conditions

BPH Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Alberta Urology Institute Research Centre, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bipolar transurethral resection of the prostate

Procedure

Bipolar TURP

Other names: Vista, Bipolar TURP

Monopolar transurethral resection of the prostate

Procedure

Monopolar TURP

Other names: Monopolar TURP

Primary outcomes

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

    Time frame: 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.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Gyrus ACMI, Inc.

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
Jul 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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