BPH-6: Comparison of the UroLift System to TURP for Benign Prostatic Hyperplasia
- Conditions
- Benign Prostatic Hyperplasia
- Registration Number
- NCT01533038
- Lead Sponsor
- NeoTract, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 80
• Men >50 years old with moderate-severe BPH
- Size, width of prostate
- Other medical condition or co-morbidity contraindicative for TURP or UroLift
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Herlev Hospital
🇩🇰Herlev, Denmark
PAN Klinik
🇩🇪Cologne, Germany
University Hospital Freiburg
🇩🇪Freiburg, Germany
Ludwigs-Maximilians Universität / Klinikum Großhadern
🇩🇪Munich, Germany
University Hospital Tuebingen
🇩🇪Tuebingen, Germany
Frimley Park Hospital
🇬🇧Frimley, United Kingdom
The Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
City Hospitals Sunderland NHS Foundation Trust
🇬🇧Sunderland, United Kingdom
Musgrove Park Hospital
🇬🇧Taunton, United Kingdom
Herlev Hospital🇩🇰Herlev, Denmark