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|
- Collection of Post-treatment Catheterization for Safety [ Time Frame: Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days ] [ Designated as safety issue: Yes ]The primary safety endpoint is an assessment of the rate of extended post-operative urinary catheterization in the subjects randomized to the UroLift group of the study in the ITT group. The extended post-operative urinary catheterization rate is defined as including those subjects who required catheterization within the first 3 days as part of post-operative management for inability to void, and required the catheter for more than 7 days. 2/140 met this endpoint.
- Comparison of IPSS for Efficacy [ Time Frame: 3 month ] [ Designated as safety issue: No ]
The UroLift system will be considered superior to the Control if the mean International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 months demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for cystoscopy alone.
The IPSS is an 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH).
0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic
- Mean UroLift Improvement in IPSS at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic. To meet co-primary effectiveness endpoint, the lower bound of a one-sided 97.5% confidence interval of IPSS mean percent change from baseline at Month 12 in the UroLift group must be greater than or equal to 30%.
- Sexual Function [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]Over the 12 month follow-up period, the proportion of UroLift patients who experience de novo sustained erectile dysfunction and retrograde ejaculation will be reported. Control subjects are not included in this analysis since controls could crossover option opened at 3 months.
|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 underwent the UroLift system procedure. The subject was blinded to his randomization into control or treatment group. Unblinding will occurred at 3 months post procedure after the assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to retreat with the UroLift system if he met the retreatment inclusion and exclusion criteria. Subjects that went on to UL retreatment within the first 12 months started their follow-up schedule over and were considered treatment failures. All UL subjects will be followed a minimum of 5 years.
Device: UroLift System
The NeoTract UroLift System is a medical device approved for sale in the United States, European Union, and several other countries (see www.urolift.com). It was developed 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 underwent a cystoscopy procedure. The subject was blinded to his randomization into the control or treatment group. Unblinding will occurred at 3 months post procedure, after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo a UL procedure if he met crossover 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, or receive no treatment at all, which would require participation through 12 months.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294150
|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|