BPH-6: Comparison of the UroLift System to TURP for Benign Prostatic Hyperplasia
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.
Benign Prostatic Hyperplasia
Device: UroLift(R) System
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||BPH-6: A UroLift® System Post Market Multi-Center Randomized Study|
- 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 ] [ Designated as safety issue: Yes ]
- LUTS: ≥ 30% reduction in IPSS compared to baseline
- Recovery Experience: Return to pre-operative activity levels by 1 month
- Erectile function: Less than 6-point reduction in SHIM compared to baseline.
- Ejaculatory function: Response on MSHQ-EjD that indicates emission of semen. This excludes the response "Could not ejaculate"
- Continence: ISI score of 4 points or less at all follow-up time points
- 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.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: UroLift System treatment||
Device: UroLift(R) System
The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra.
|Active Comparator: Transurethral Resection of the Prostate||
Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck.
|Cologne, Germany, 50667|
|University Hospital Freiburg|
|Freiburg, Germany, 79106|
|Ludwigs-Maximilians Universität / Klinikum Großhadern|
|Munich, Germany, 81377|
|University Hospital Tuebingen|
|The Royal Hallamshire Hospital|
|Sheffield, United Kingdom|
|City Hospitals Sunderland NHS Foundation Trust|
|Sunderland, United Kingdom|
|Frimley Park Hospital|
|Surrey, United Kingdom, GU16 7UJ|
|Musgrove Park Hospital|
|Taunton, United Kingdom, TA1 5DA|
|Principal Investigator:||Francesco Montorsi, MD||University Vita Salute San Raffaele|