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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
206
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.
The Control Group will undergo cystoscopy.
Subjects crossed over and received the UroLift System from the Control Group.
Genesis Research LLC
San Diego, California, United States
Shahram S. Gholami MD - A Professional Corp.
San Jose, California, United States
Collection of Post-treatment Catheterization for Safety
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.
Time frame: Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days
Comparison of IPSS for Efficacy
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). SCORING: 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic
Time frame: 3 month
Mean UroLift Improvement in IPSS at 12 Months
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%.
Time frame: 12 months
Sexual Function
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Urology Associates of Denver
Englewood, Colorado, United States
Advanced Urology Institute
Daytona Beach, Florida, United States
Pinellas Urology
St. Petersburg, Florida, United States
Northwestern University
Chicago, Illinois, United States
Chesapeake Urology
Baltimore, Maryland, United States
Sheldon J. Freedman, M.D., Ltd.
Las Vegas, Nevada, United States
Weill Cornell Medical College
New York, New York, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
...and 9 more locations
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.
Time frame: 12 Months