UroLift System TOlerability and ReCovery When Administering Local Anesthesia (LOCAL)
The purpose of the study is to evaluate procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||L.O.C.A.L. Study -- UroLift System TOlerability and ReCovery When Administering Local Anesthesia|
- Quality of Recovery [ Time Frame: 1 Month ] [ Designated as safety issue: No ]Primary effectiveness will be achieved when 80% (95% lower confidence limit) of subjects achieve a score of 80 or more on the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.
- Resolution of BPH, Procedural Recovery Measures, and Health Economics [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]Over the 12 month follow-up period, lower urinary tract symptoms (LUTS), quality of life (QOL), uroflowmetry, sexual function, pain tolerability of procedure, health economic data, patient satisfaction and device related adverse events will be assessed.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||September 2018|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: UroLift® System
Single-arm of qualified subjects receiving UroLift® System intervention.
Device: UroLift® System
The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, and Canada. The UroLift® System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older. 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.
The randomized portion of the study is a prospective, multicenter, non-blinded, single arm trial evaluating procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia. All subjects undergo UroLift system treatment and will be followed through 5 years after receiving the investigational device.
|United States, California|
|Premier Urology/San Diego Uro-Research|
|San Diego, California, United States, 92103|
|United States, Florida|
|Atlantic Urological Associates|
|Daytona Beach, Florida, United States, 32114|
|St. Petersburg, Florida, United States, 33710|
|United States, Maryland|
|Baltimore, Maryland, United States, 21237|
|United States, Nevada|
|Sheldon J. Freedman, M.D., Ltd.|
|Las Vegas, Nevada, United States, 89148|
|United States, South Carolina|
|Carolina Urologic Research Center|
|Myrtle Beach, South Carolina, United States, 29572|
|United States, Utah|
|Jean Brown Research|
|Salt Lake City, Utah, United States, 84124|