The Safety and Effectiveness of UroLift: LIFT Pivotal Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NeoTract, Inc.
ClinicalTrials.gov Identifier:
NCT01294150
First received: February 7, 2011
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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:
  • Comparison of IPSS for Efficacy [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    3 Month comparison between control and treatment arms of IPSS

  • Collection of post-treatment catheterization for safety [ Time Frame: > 7 days ] [ Designated as safety issue: Yes ]
    Post-procedure catheterization will be collected.

  • IPSS improvement of UroLift patients for efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    12 month comparison to baseline IPSS scores.


Secondary Outcome Measures:
  • Sexual Function [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Over the 12 month follow-up period, the proportion of patients who experience de novo sustained erectile dysfunction and retrograde ejaculation will be reported.


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 will undergo the UroLift system procedure. The subject will be blinded as to whether he is in the control or treatment group. Unblinding will occur at 3 months post procedure after the assessments are completed. Subjects treated with the UroLift system may experience return of LUTS. Between 3 and 12 month follow-up assessments, a subject may be retreated with the UroLift system if he meets the retreatment inclusion and exclusion criteria or treated with other approved therapies. Patients that go on for retreatment within the first 12 months will be considered treatment failures. No matter which retreatment therapy, all subjects will be followed at a minimum of 5 years per the assessment schedule.
Device: UroLift System
The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and 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 will undergo a cystoscopy procedure. The subject will be blinded as to whether he is in the control or treatment group. Unblinding will occur at 3 months post procedure after follow-up assessments are completed. Subjects undergoing the cystoscopy procedure may experience return of LUTS. Between 3 and 12 month follow-up assessments, a subject may be treated with the UroLift system if he meets the retreatment 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 after which follow-up through 12 months is required.
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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01294150

Locations
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
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.
Investigators
Principal Investigator: Claus Roehrborn, MD University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: NeoTract, Inc.
ClinicalTrials.gov Identifier: NCT01294150     History of Changes
Other Study ID Numbers: 1012CP
Study First Received: February 7, 2011
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014