Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)

Lawson Health Research Institute

Status and phase

Completed

Phase 4

Conditions

Benign Prostatic Hyperplasia

BPH

Treatments

Procedure: Bipolar Transurethral Resection of the Prostate

Procedure: Monopolar Transurethral Resection of the Prostate

Study type

Interventional

Funder types

Other

Identifiers

NCT00199550

R-04-533

Details and patient eligibility

About

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

Full 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.

Enrollment

43 patients

Sex

Male

Ages

50 to 85 years old

Volunteers

No 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.