Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

This study enrolled and implanted 133 subjects at 15 sites in the US under the original IDE.

Subjects were given the option to extend out to 3 years post activation, with annual visits at 2 and 3 years post activation (96 and 144 weeks post-activation).

Subjects who are still active in the original IDE study will be offered consecutive enrollment in the post approval study and will be given the option to receive a new implant. Subjects who are no longer active, or have exited the study will be given the option to reenter the study and complete two follow-up visits. Subjects re-entering the study will not have the option to receive a new implant. Post approval follow-up of subjects will occur through the year 5 visit (257 weeks post-activation of their original device). Reimplantation of a new eCoin would not reset their follow-up clock.

Primary Inclusion Criteria:

• Women and men between 18 and 80 years old.
• 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.
• Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists).
• 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:

• Predominant stress urinary incontinence with more than 1/3 stress urinary incontinent episodes when compared to total urinary incontinent episodes.
• Clinically significant bladder outlet obstruction.
• Clinically significant pelvic organ prolapse beyond the hymenal ring.
• Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.