Phase
Condition
Enuresis
Peyronie's Disease
Treatment
Optilume Urethral DCB
Clinical Study ID
Ages 22-65 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male subjects between 22 and 65 years of age
Subject diagnosed with a stricture in the anterior urethra that is able to betreated with the Optilume Urethral DCB in accordance with the approved Instructionsfor Use
Subject is willing to provide written informed consent and comply with studyrequired follow-up assessments
Subject able to provide viable semen samples and baseline semen qualitycharacteristics are above reference values based on below criteria (average of 2samples):
total sperm ≥39 million
sperm concentration ≥15 million/mL
total motility ≥40%
progressive motility ≥32%
morphology ≥4%
Exclusion
Exclusion Criteria:
Subjects with a known hypersensitivity to paclitaxel or structurally relatedcompounds
Subjects with a history of vasectomy or other condition that may inhibit semen/spermproduction or ejaculatory function
Subjects currently taking 5-alpha reductase inhibitors, alpha-blockers, selectiveserotonin reuptake inhibitors, or hormone replacement therapy without appropriatewashout
Subject is unwilling to abstain or utilize a condom for 30 days after the procedure
Subject is unwilling to utilize highly effective contraception for 6 months afterthe procedure if partner is of childbearing potential
History of cancer in any body system that is not considered in complete remission
Study Design
Study Description
Connect with a study center
Arkansas Urology
Little Rock, Arkansas 72211
United StatesActive - Recruiting
Orlando Health
Orlando, Florida 32806
United StatesActive - Recruiting
Florida Urology
Tampa, Florida 33615
United StatesActive - Recruiting
Regional Urology
Shreveport, Louisiana 71106
United StatesActive - Recruiting
Chesapeake
Hanover, Maryland 21076
United StatesCompleted
Freedman Urology
Las Vegas, Nevada 89144
United StatesActive - Recruiting
New Jersey Urolgy
Millburn, New Jersey 07041
United StatesSite Not Available
Western New York
Cheektowaga, New York 14225
United StatesActive - Recruiting
Urology Clinics of North Texas
Dallas, Texas 75231
United StatesActive - Recruiting
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