Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)

A Prospective Randomized Clinical Trial of 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.

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.

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.