BPH-6: A UroLift® System Post Market Multi-Center Randomized Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Benign Prostatic Hyperplasia
- Sponsor
- NeoTract, Inc.
- Enrollment
- 80
- Locations
- 9
- Primary Endpoint
- Responder Analysis: A Subject is a Responder at the 12 Month Follow-up Time Point if All 6 Thresholds of the BPH-6 Endpoint Are Met
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to compare the UroLift System Treatment to Transurethral Resection of the Prostate (TURP) in improving a patient's overall quality of life, while evaluating healthcare expenditures associated with each therapy.
Detailed Description
The study is a prospective, consecutive, multi-center, 1:1 randomized study (UroLift System:TURP). The study is intended to be conducted at up to 20 different centers in Europe and Canada to enroll up to 100 subjects. Subject follow-up visits are at 2 weeks, 1, 3, 6, 12 and 24 months for all subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men \>50 years old with moderate-severe BPH
Exclusion Criteria
- •Size, width of prostate
- •Other medical condition or co-morbidity contraindicative for TURP or UroLift
Outcomes
Primary Outcomes
Responder Analysis: A Subject is a Responder at the 12 Month Follow-up Time Point if All 6 Thresholds of the BPH-6 Endpoint Are Met
Time Frame: Month 12
1. LUTS: ≥ 30% reduction in IPSS compared to baseline 2. Recovery Experience: Return to pre-operative activity levels by 1 month 3. Erectile function: Less than 6-point reduction in SHIM compared to baseline. 4. Ejaculatory function: Response on MSHQ-EjD that indicates emission of semen. This excludes the response "Could not ejaculate" 5. Continence: ISI score of 4 points or less at all follow-up time points 6. Safety: No procedure-related adverse event greater than Grade I on the Clavien-Dindo classification system modified for TURP at any time during procedure or follow up.