BPH, Benign Prostatic Hyperplasia
Conditions
Keywords
Transurethral Resection of Prostate, TURP
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.
Interventions
Bipolar TURP
Monopolar TURP
Sponsors
Gyrus ACMI, Inc.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
50 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of efficacy will be determined by comparing pre and post-operative symptom scores. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada
Outcome results
None listed