Clinical trial NCT01294150: The Safety and Effectiveness of UroLift: LIFT Pivotal Study
Official title: Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of Lower Urinary Tract Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: NeoTract, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-11
Enrollment: 206
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Collection of Post-treatment Catheterization for Safety
timeFrame: Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days
measure: Comparison of IPSS for Efficacy
timeFrame: 3 month
measure: Mean UroLift Improvement in IPSS at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Sexual Function
timeFrame: 12 Months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Genesis Research LLC
state: California
city: San Jose
country: United States
facility: Shahram S. Gholami MD - A Professional Corp.
state: California
city: Englewood
country: United States
facility: Urology Associates of Denver
state: Colorado
city: Daytona Beach
country: United States
facility: Advanced Urology Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Pinellas Urology
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: Chesapeake Urology
state: Maryland
city: Las Vegas
country: United States
facility: Sheldon J. Freedman, M.D., Ltd.
state: Nevada
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Temple
country: United States
facility: Scott and White Healthcare
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: Figtree
country: Australia
facility: Figtree Private Hospital
state: New South Wales
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Port Macquarie
country: Australia
facility: Port Macquarie Urology Centre
city: Oakville
country: Canada
facility: Oakville Trafalgar Memorial Hospital
state: Ontario
city: Toronto
country: Canada
facility: Cam Am HIFU
state: Ontario
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Claus Roehrborn, MD
role: PRINCIPAL_INVESTIGATOR
References: