Post-Market Study to Assess iTind Safety in Comparison to UroLift
Start Date
9/26/2022
Completion Date
12/31/2031
Summary
The study objective is to evaluate the safety of the iTind device comparied to UroLift.
Detailed Description
Both iTind and UroLift are minimally invasive treatment options for relieving lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). The iTind device is a temporary, self-expanding nitinol implant that remains in place for 5 to 7 days to reshape the prostatic urethra through localized ischemic pressure and tissue remodeling. In contrast, the UroLift system involves the permanent placement of transprostatic implants that retract the enlarged lateral lobes of the prostate to widen the urethral lumen. This study is designed to directly compare the safety and effectiveness of the iTind device versus the UroLift system in treating LUTS due to BPH.
Eligibility Criteria
Age Range: 50 years to No maximum
Interventions
iTind
UroLift
Conditions
Locations
Mayo Clinic Arizona
Phoenix, Arizona 85054
United States
Arizona Urology Specialists
Tucson, Arizona 85704
United States
Urology Associates of Central California
Fresno, California 93720
United States
Golden State Urology
Sacramento, California 95823
United States
NorthShore University Health System Research Institute
Evanston, Illinois 60201
United States
Southeast Louisiana Veterans Health Care System
New Orleans, Louisiana 70119
United States
Minnesota Urology
Woodbury, Minnesota 55125
United States
Adult & Pediatric Urology
Omaha, Nebraska 68124
United States
Pacific West Urology
Las Vegas, Nevada 89121
United States
Feinstein Institutes for Medical Research / Northwell Health
Syosset, New York 11791
United States
The Conrad Pearson Clinic
Germantown, Tennessee 38138
United States
Midtown Urology Associates
Austin, Texas 78705
United States
Houston Metro Urology
Houston, Texas 77027
United States
The Urology Place
San Antonio, Texas 78240
United States
Potomac Urology Center
Alexandria, Virginia 22311
United States
Chelsea and Westminster Hospital
Isleworth, Middlesex TW7 6AF
United Kingdom
Queen Margaret Hospital
Dunfermline, KY12 0SU
United Kingdom
Frimley Park Hospital
London, GU16 7UJ
United Kingdom
Norfolk & Norwich University Hospital
Norwich, NR4 7UY
United Kingdom