The Safety and Effectiveness of UroLift: LIFT Pivotal Study

Not Applicable

Completed

Conditions: Benign Prostatic Hyperplasia

Registration Number: NCT01294150

Lead Sponsor: NeoTract, Inc.

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 206

Inclusion Criteria

Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)

Exclusion Criteria

Size, volume,length of prostate

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Collection of Post-treatment Catheterization for Safety	Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days	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	3 month	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
Mean UroLift Improvement in IPSS at 12 Months	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%.

Secondary Outcome Measures

Name	Time	Method
Sexual Function	12 Months	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.

Trial Locations

Locations (19): Genesis Research LLC
🇺🇸
San Diego, California, United States
Shahram S. Gholami MD - A Professional Corp.
🇺🇸
San Jose, California, United States
Urology Associates of Denver
🇺🇸
Englewood, Colorado, United States
Advanced Urology Institute
🇺🇸
Daytona Beach, Florida, United States
Pinellas Urology
🇺🇸
Saint 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
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Genesis Research LLC
🇺🇸San Diego, California, United States