The Safety and Effectiveness of UroLift: LIFT Pivotal Study
LIFT
Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of Lower Urinary Tract Symptoms
1 other identifier
interventional
206
3 countries
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2011
Longer than P75 for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 7, 2011
CompletedFirst Posted
Study publicly available on registry
February 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedResults Posted
Study results publicly available
August 13, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2017
CompletedSeptember 5, 2018
August 1, 2018
2 years
February 7, 2011
April 1, 2014
August 31, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (1)
Sexual Function
12 Months
Study Arms (3)
UroLift System
ACTIVE COMPARATORThe 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.
Cystoscopy
SHAM COMPARATORThe 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.
Crossover
ACTIVE COMPARATORBetween 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.
Interventions
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.
Subjects crossed over and received the UroLift System from the Control Group.
Eligibility Criteria
You may qualify if:
- Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)
You may not qualify if:
- Size, volume,length of prostate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NeoTract, Inc.lead
Study Sites (19)
Genesis Research LLC
San Diego, California, 92123, United States
Shahram S. Gholami MD - A Professional Corp.
San Jose, California, 95124, United States
Urology Associates of Denver
Englewood, Colorado, 80113, United States
Advanced Urology Institute
Daytona Beach, Florida, 32114, United States
Pinellas Urology
St. Petersburg, Florida, 33710, United States
Northwestern University
Chicago, Illinois, 60611, United States
Chesapeake Urology
Baltimore, Maryland, 21237, United States
Sheldon J. Freedman, M.D., Ltd.
Las Vegas, Nevada, 89144, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Scott and White Healthcare
Temple, Texas, 76504, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Figtree Private Hospital
Figtree, New South Wales, 2525, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Port Macquarie Urology Centre
Port Macquarie, 2444, Australia
Oakville Trafalgar Memorial Hospital
Oakville, Ontario, L6J 3L7, Canada
Cam Am HIFU
Toronto, Ontario, MSG 1E2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Emily Hergenreter Director of Clinical Affairs
- Organization
- NeoTract
Study Officials
- PRINCIPAL INVESTIGATOR
Claus Roehrborn, MD
University of Texas Southwestern Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2011
First Posted
February 11, 2011
Study Start
February 1, 2011
Primary Completion
February 1, 2013
Study Completion
July 5, 2017
Last Updated
September 5, 2018
Results First Posted
August 13, 2015
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share