Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
The Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.
Arkansas Urology
Little Rock, Arkansas, United States
RECRUITINGOrlando Health
Orlando, Florida, United States
RECRUITINGFlorida Urology
Tampa, Florida, United States
Primary Safety Endpoint
Average Change in Sperm Concentration from baseline to 3-months
Time frame: 3-months
Secondary Safety Endpoint
Proportion of Subjects Experiencing ≥50% Decrease in Sperm Concentration from Baseline at 3 and 6 Months
Time frame: 6-months
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Regional Urology
Shreveport, Louisiana, United States
COMPLETEDChesapeake
Hanover, Maryland, United States
COMPLETEDFreedman Urology
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RECRUITINGNew Jersey Urolgy
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COMPLETEDWestern New York
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RECRUITINGUrology Clinics of North Texas
Dallas, Texas, United States
RECRUITING