The Safety and Effectiveness of UroLift: LIFT Pivotal Study

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
NeoTract, Inc. Identifier:
First received: February 7, 2011
Last updated: July 15, 2015
Last verified: July 2015

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.

Condition Intervention Phase
Benign Prostatic Hyperplasia
Device: UroLift System
Other: Cystoscopy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of Lower Urinary Tract Symptoms

Resource links provided by NLM:

Further study details as provided by NeoTract, Inc.:

Primary Outcome Measures:
  • Collection of Post-treatment Catheterization for Safety [ Time Frame: Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 month ] [ Designated as safety issue: No ]

    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).


    0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic

  • Mean UroLift Improvement in IPSS at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    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.

Enrollment: 206
Study Start Date: February 2011
Estimated Study Completion Date: February 2017
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: UroLift System
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.
Device: UroLift System
The NeoTract UroLift System is a medical device approved for sale in the United States, European Union, and several other countries (see 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.
Sham Comparator: Cystoscopy
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.
Other: Cystoscopy
The Control Group will undergo cystoscopy.

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.


Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Size, volume,length of prostate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01294150

United States, California
SD Uro Research
San Diego, California, United States, 92103
Good Samaritan Hospital
San Jose, California, United States, 95124
United States, Colorado
Urology Associates of Denver
Englewood, Colorado, United States, 80113
United States, Florida
Atlantic Urological Associates
Daytona Beach, Florida, United States, 32114
Pinellas Urology
St. Petersburg, Florida, United States, 33710
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
Chesapeake Urology
Baltimore, Maryland, United States, 21237
United States, Nevada
Sheldon J. Freedman, M.D., Ltd.
Las Vegas, Nevada, United States, 89148
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Scott and White Healthcare
Temple, Texas, United States, 76504
United States, Utah
Western Urological Clinic
Salt Lake City, Utah, United States, 84107
Australia, New South Wales
Figtree Hospital
Figtree, New South Wales, Australia, 2525
Australia, Victoria
Austin Hospital
Heidelberg, Victoria, Australia
Port Macquarie Urology Centre
Port Macquarie, Australia, 2444
Canada, Ontario
Oakville Trafalgar Memorial Hospital
Oakville, Ontario, Canada, L6J 3L7
The Cosmetic Surgery Hospital
Woodbridge, Ontario, Canada, L4L 1S7
Sponsors and Collaborators
NeoTract, Inc.
Principal Investigator: Claus Roehrborn, MD University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: NeoTract, Inc. Identifier: NCT01294150     History of Changes
Other Study ID Numbers: 1012CP
Study First Received: February 7, 2011
Results First Received: April 1, 2014
Last Updated: July 15, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases
Signs and Symptoms
Urological Manifestations processed this record on October 08, 2015