Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

Launched by VALENCIA TECHNOLOGIES CORPORATION · Jun 3, 2018

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Primary Inclusion Criteria:
• • 1. Women and men between 18 and 80 years old.
• • 2. Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and stress incontinence with a predominant urgency component (selfreported), for at least 6 months.
• • 3. Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists).
• • 4. Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or percutaneous tibial nerve stimulation.
• Primary Exclusion Criteria:
• • 1. Predominant stress urinary incontinence with more than 1/3 stress urinary incontinent episodes when compared to total urinary incontinent episodes.
• • 2. Clinically significant bladder outlet obstruction.
• • 3. Clinically significant pelvic organ prolapse beyond the hymenal ring.
• • 4. Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.