Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Start Date
2/14/2022
Completion Date
12/30/2026
Summary
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
Detailed Description
Male subject diagnosed with a stricture in the anterior urethra that can be treated with the Optilume Urethral DCB. Thirty-Four (34) subjects will be enrolled at up to ten (10) sites in the United States. Clinical follow-up will be conducted at 30 days, 3 months, 6 months, and 12 months post-treatment evaluating Lower Urinary Tract Symptoms (LUTS), sexual function, and voiding function. Semen quality parameters will be assessed at Baseline, 3 months, and 6 months post-treatment. Subjects with an abnormal semen quality result at 6 months will have an additional assessment at 12 months post-treatment and periodically thereafter until results return to normal.
Eligibility Criteria
Age Range: 22 years to 65 years
Interventions
Optilume Urethral DCB
Conditions
Locations
Arkansas Urology
Little Rock, Arkansas 72211
United States
Orlando Health
Orlando, Florida 32806
United States
Florida Urology
Tampa, Florida 33615
United States
Regional Urology
Shreveport, Louisiana 71106
United States
Chesapeake
Hanover, Maryland 21076
United States
Freedman Urology
Las Vegas, Nevada 89144
United States
New Jersey Urolgy
Millburn, New Jersey 07041
United States
Western New York
Cheektowaga, New York 14225
United States
Urology Clinics of North Texas
Dallas, Texas 75231
United States