Clinical trial NCT00199550: Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)
Official title: A Prospective Randomized Clinical Trial of Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: BPH
Benign Prostatic Hyperplasia
Keywords: Transurethral Resection of Prostate
TURP
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Gyrus ACMI, Inc.
First posted: 2005-09-20
Enrollment: 43
Sex: MALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of efficacy will be determined by comparing pre and post-operative symptom scores.
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Alberta Urology Institute Research Centre
state: Alberta
city: Vancouver
country: Canada
facility: Prostate Centre at Vancouver General Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Can-Med Clinical Research Inc
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton District Urology Associaton
state: Ontario
city: Kingston
country: Canada
facility: Centre for Advanced Urological Research at Queen's University
state: Ontario
city: London
country: Canada
facility: Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London
state: Ontario
Study officials:
affiliation: Urology, St. Joseph's Hospital, University of Western Ontario
name: Hassan Razvi, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: