A prospective Multicenter Randomized Study Comparing Photoselective Vaporization of the Prostate with the GreenLight XPS Laser System and Transurethral resection of the Prostate for Treatment of benign Prostatis Hyperplasia
Phase 3
Completed
- Conditions
- 10036958Benign Prostate Hyperplasia
- Registration Number
- NL-OMON36344
- Lead Sponsor
- American Medical Systems
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
Inclusion Criteria
The patient is candidate for desobstructive surgery of the prostate due to symptomatic BPH by TURP or PVP
The IPSS score is > 12
Qmax < 15 ml/sec
Prostate Volume < 100 cc
Exclusion Criteria
Life expectancy < 2 years
Active Urinary Tract Infection
Prostatitis
Neurogenic bladder
Diagnosis prostate carcinoma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To demonstrate that BPH symptoms after PVP are not worse when compared to TURP<br /><br>at 6 months post procedure measured via international prostate symptom score<br /><br>(IPSS) for the treatment of BPH. </p><br>
- Secondary Outcome Measures
Name Time Method