Effectiveness of eCoin at Sensory and Subsensory Amplitudes

Key Inclusion Criteria:

1. Individual with diagnosis of overactive bladder with urgency urinary incontinence -daily UUI with a predominantly urgency component

2. Individual is intolerant of or has an inadequate response to any ofanticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or who haveundergone percutaneous tibial nerve stimulation (PTNS).

3. Individual is determined to be a suitable surgical candidate by physician.

Key Exclusion Criteria:

1. Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFUrequirements.

2. Individual has predominantly stress urinary incontinence (greater than 1/3 of leakson baseline diary are stress).

3. Individual has clinically significant bladder outlet obstruction.

4. Individual has an active urinary tract infection at time of enrollment or has hadfour or more symptomatic UTI's in the last 12 months.

5. Individual has significant lower urinary tract pain or has been diagnosed withinterstitial cystitis or bladder pain syndrome that is actively being managed.

6. Individual has post void residual greater than 200 cc.

7. Individual has an active diagnosis of bladder, urethral, or prostate cancer.

8. Individual has had a prior anti-stress incontinence surgery within the last year.

9. Individual has uncontrolled diabetes mellitus (Hemoglobin A1C>7).

10. Individual is neutropenic or immune-compromised.

11. Individual has lower extremity pathology such as:

12. Previous surgery and/or significant scarring at the planned implant location

13. Ongoing dermatologic condition at the implant site, including but not limitedto dermatitis and autoimmune disorders

14. Clinically significant peripheral neuropathy in the lower extremities

15. Pitting edema at the implant location (≥ 2+ is excluded)

16. Inadequate skin integrity or any evidence of an infection or inflammation ineither lower leg

17. Moderate to severe varicose veins

18. Open wounds or recent trauma

19. Arterial and/or vasculitis disease in the lower extremities

20. Chronic venous insufficiency with a history of skin change (hyperpigmentation,lipodermatosclerosis, ulceration) in the ankle region

21. Individual has neurogenic bladder dysfunction.

22. Individual is aware that he or she will need an MRI scan other than ahead/neck/shoulder MRI during the study period.

23. Any condition that, in the investigator's opinion, would preclude participation inthe study (e.g., comorbidity that places subject at increased risk for surgicalintervention, medical condition that may increase the risk associated with studyparticipation or may interfere with interpretation of study results, inability toadhere to the visit schedule, such as morbid obesity, clotting or bleeding disorder)