Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)

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

Detailed Description
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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.

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

Conditions
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BPH, Benign Prostatic Hyperplasia

Intervention / Treatment
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* Procedure: Bipolar Transurethral Resection of the Prostate
* Procedure: Monopolar Transurethral Resection of the Prostate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Bipolar Electrosurgical Unit | Procedure: Bipolar Transurethral Resection of the Prostate<br>* Bipolar TURP<br>* Other names: Vista, Bipolar TURP;|
| Active Comparator: 1<br>Monopolar Electrosurgical Unit | Procedure: Monopolar Transurethral Resection of the Prostate<br>* Monopolar TURP<br>* Other names: Monopolar TURP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of efficacy will be determined by comparing pre and post-operative symptom scores. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transurethral Resection of Prostate, TURP