Benign Prostatic Hyperplasia Clinical Trial
— LIFTOfficial title:
Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of Lower Urinary Tract Symptoms
NCT number | NCT01294150 |
Other study ID # | 1012CP |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2011 |
Est. completion date | July 5, 2017 |
Verified date | August 2018 |
Source | NeoTract, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 206 |
Est. completion date | July 5, 2017 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH) Exclusion Criteria: - Size, volume,length of prostate |
Country | Name | City | State |
---|---|---|---|
Australia | Figtree Private Hospital | Figtree | New South Wales |
Australia | Austin Hospital | Heidelberg | Victoria |
Australia | Port Macquarie Urology Centre | Port Macquarie | |
Canada | Oakville Trafalgar Memorial Hospital | Oakville | Ontario |
Canada | Cam Am HIFU | Toronto | Ontario |
United States | Chesapeake Urology | Baltimore | Maryland |
United States | Northwestern University | Chicago | Illinois |
United States | UT Southwestern Medical Center | Dallas | Texas |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Advanced Urology Institute | Daytona Beach | Florida |
United States | Urology Associates of Denver | Englewood | Colorado |
United States | Sheldon J. Freedman, M.D., Ltd. | Las Vegas | Nevada |
United States | Carolina Urologic Research Center | Myrtle Beach | South Carolina |
United States | Weill Cornell Medical College | New York | New York |
United States | Pinellas Urology | Saint Petersburg | Florida |
United States | Jean Brown Research | Salt Lake City | Utah |
United States | Genesis Research LLC | San Diego | California |
United States | Shahram S. Gholami MD - A Professional Corp. | San Jose | California |
United States | Scott and White Healthcare | Temple | Texas |
Lead Sponsor | Collaborator |
---|---|
NeoTract, Inc. |
United States, Australia, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days | |
Primary | 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 |
3 month | |
Primary | 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%. | 12 months | |
Secondary | Sexual Function | 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. | 12 Months |
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