Back to resultsThe Safety and Effectiveness of UroLift: LIFT Pivotal Study (LIFT)
Primary Purpose
Benign Prostatic Hyperplasia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
UroLift System
Cystoscopy
Crossover
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia
Eligibility Criteria
Inclusion Criteria:
- Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)
Exclusion Criteria:
- Size, volume,length of prostate
Sites / Locations
- Genesis Research LLC
- Shahram S. Gholami MD - A Professional Corp.
- Urology Associates of Denver
- Advanced Urology Institute
- Pinellas Urology
- Northwestern University
- Chesapeake Urology
- Sheldon J. Freedman, M.D., Ltd.
- Weill Cornell Medical College
- Geisinger Medical Center
- Carolina Urologic Research Center
- UT Southwestern Medical Center
- Scott and White Healthcare
- Jean Brown Research
- Figtree Private Hospital
- Austin Hospital
- Port Macquarie Urology Centre
- Oakville Trafalgar Memorial Hospital
- Cam Am HIFU
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Sham Comparator
Active Comparator
Arm Label
UroLift System
Cystoscopy
Crossover
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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
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%.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01294150
Brief Title
The Safety and Effectiveness of UroLift: LIFT Pivotal Study
Acronym
LIFT
Official Title
Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of Lower Urinary Tract Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
July 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeoTract, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
206 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UroLift System
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cystoscopy
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Crossover
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
UroLift System
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cystoscopy
Intervention Description
The Control Group will undergo cystoscopy.
Intervention Type
Device
Intervention Name(s)
Crossover
Intervention Description
Subjects crossed over and received the UroLift System from the Control Group.
Primary Outcome Measure Information:
Title
Collection of Post-treatment Catheterization for Safety
Description
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
Title
Comparison of IPSS for Efficacy
Description
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
Title
Mean UroLift Improvement in IPSS at 12 Months
Description
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
Secondary Outcome Measure Information:
Title
Sexual Function
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)
Exclusion Criteria:
Size, volume,length of prostate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Roehrborn, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Genesis Research LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Shahram S. Gholami MD - A Professional Corp.
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Facility Name
Urology Associates of Denver
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Advanced Urology Institute
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Pinellas Urology
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Chesapeake Urology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Sheldon J. Freedman, M.D., Ltd.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Scott and White Healthcare
City
Temple
State/Province
Texas
ZIP/Postal Code
76504
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Figtree Private Hospital
City
Figtree
State/Province
New South Wales
ZIP/Postal Code
2525
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
Port Macquarie Urology Centre
City
Port Macquarie
ZIP/Postal Code
2444
Country
Australia
Facility Name
Oakville Trafalgar Memorial Hospital
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 3L7
Country
Canada
Facility Name
Cam Am HIFU
City
Toronto
State/Province
Ontario
ZIP/Postal Code
MSG 1E2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Safety and Effectiveness of UroLift: LIFT Pivotal Study
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