The Safety and Effectiveness of UroLift: LIFT Pivotal Study
The purpose of the study is to evaluate the safety and effectiveness of the UroLift(R) System when used in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the improvement of International Prostate Symptom Score (IPSS) and safety will be reviewed based on pertinent adverse events.
Benign Prostatic Hyperplasia
Device: UroLift System
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of Lower Urinary Tract Symptoms|
- Comparison of IPSS for Efficacy [ Time Frame: 3 month ] [ Designated as safety issue: No ]3 Month comparison between control and treatment arms of IPSS
- Collection of post-treatment catheterization for safety [ Time Frame: > 7 days ] [ Designated as safety issue: Yes ]Post-procedure catheterization will be collected.
- IPSS improvement of UroLift patients for efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]12 month comparison to baseline IPSS scores.
- Sexual Function [ Time Frame: 12 Months ] [ Designated as safety issue: No ]Over the 12 month follow-up period, the proportion of patients who experience de novo sustained erectile dysfunction and retrograde ejaculation will be reported.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||February 2017|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Active Comparator: UroLift System
The treatment group subjects will undergo the UroLift system procedure. The subject will be blinded as to whether he is in the control or treatment group. Unblinding will occur at 3 months post procedure after the assessments are completed. Subjects treated with the UroLift system may experience return of LUTS. Between 3 and 12 month follow-up assessments, a subject may be retreated with the UroLift system if he meets the retreatment inclusion and exclusion criteria or treated with other approved therapies. Patients that go on for retreatment within the first 12 months will be considered treatment failures. No matter which retreatment therapy, all subjects will be followed at a minimum of 5 years per the assessment schedule.
Device: UroLift 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.
Sham Comparator: Cystoscopy
The control group subjects will undergo a cystoscopy procedure. The subject will be blinded as to whether he is in the control or treatment group. Unblinding will occur at 3 months post procedure after follow-up assessments are completed. Subjects undergoing the cystoscopy procedure may experience return of LUTS. Between 3 and 12 month follow-up assessments, a subject may be treated with the UroLift system if he meets the retreatment inclusion and exclusion criteria. Subjects crossing over will then be followed for 5 years post-treatment. The subject can also be treated by other approved therapies after which follow-up through 12 months is required.
The Control Group will undergo cystoscopy.
The randomized portion of the study is a prospective, multicenter, multinational, 2:1 randomized, single-blinded controlled clinical trial comparing the IPSS of the treatment group to the IPSS of the control group at the 3 month follow-up. Subjects in the active treatment group undergo UroLift system treatment. Subjects in the control group undergo a cystoscopy procedure.
All subjects will be followed through 12 months, and through 5 years for those that receive the investigational device.
|United States, California|
|SD Uro Research|
|San Diego, California, United States, 92103|
|Good Samaritan Hospital|
|San Jose, California, United States, 95124|
|United States, Colorado|
|Urology Associates of Denver|
|Englewood, Colorado, United States, 80113|
|United States, Florida|
|Atlantic Urological Associates|
|Daytona Beach, Florida, United States, 32114|
|St. Petersburg, Florida, United States, 33710|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|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, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|United States, Pennsylvania|
|Geisinger Medical Center|
|Danville, Pennsylvania, United States, 17822|
|United States, South Carolina|
|Carolina Urologic Research Center|
|Myrtle Beach, South Carolina, United States, 29572|
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Scott and White Healthcare|
|Temple, Texas, United States, 76504|
|United States, Utah|
|Western Urological Clinic|
|Salt Lake City, Utah, United States, 84107|
|Australia, New South Wales|
|Figtree, New South Wales, Australia, 2525|
|Heidelberg, Victoria, Australia|
|Port Macquarie Urology Centre|
|Port Macquarie, Australia, 2444|
|Oakville Trafalgar Memorial Hospital|
|Oakville, Ontario, Canada, L6J 3L7|
|The Cosmetic Surgery Hospital|
|Woodbridge, Ontario, Canada, L4L 1S7|
|Principal Investigator:||Claus Roehrborn, MD||University of Texas Southwestern Medical Center|