A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)

Inclusion Criteria:

• Women and men above 18 years old with gender percentages reflective of diseaseprevalence in the U.S. population

• Individual with diagnosis of overactive bladder with urgency urinary incontinence.

• Individual has at least one urgency urinary incontinence episode on each of threedays as determined on a 3-day voiding diary.

• Individual gives written informed consent.

• Individual is mentally competent and able to understand all study requirements.

• Individual is willing and able to complete a 3-day voiding diary and quality of lifequestionnaire.

• Individual is without pharmacological treatment of overactive bladder (anticholinergic and β3-adrenoceptor agonists) for 2 weeks prior to baseline orlonger if the physician judges that the therapeutic effect is still present.

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

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

• Individual is appropriate for eCoin treatment based on the US FDA-approved IFUrequirements.

Exclusion Criteria:

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

• Individual has clinically significant bladder outlet obstruction. (Suspected bladderoutlet obstruction will be initially assessed by uroflow study with those having amaximum flow rate < 15mL/s requiring additional evaluation.)

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

• Individual has an active urinary tract infection at time of enrollment.

• Individual has known polyuria.

• Individual has significant lower urinary tract pain or has been diagnosed withinterstitial cystitis or bladder pain syndrome.

• Individual has abnormal post void residual (i.e. greater than 200 cc initially andon repeat testing after double voiding)

• Individual has clinically significant urethral stricture disease or bladder neckcontracture. (Suspected disease or contracture will be initially assessed by uroflowstudy with those having a maximum flow rate < 15mL/s requiring additionalevaluation.)

• Individual has chronic venous insufficiency with a history of skin change (hyperpigmentation, lipodermatosclerosis, ulceration) in the ankle region.

• Individual has morbid obesity and in the opinion of the investigator is not a goodcandidate for the study.

• Individual has had diagnosis of bladder, urethral, or prostate cancer.

• Individual has had a prior anti-stress incontinence sling surgery within the lastyear.

• Individual is pregnant or intends to become pregnant during the study.

• Individual has the presence of urinary fistula, bladder stone, or interstitialcystitis.

• Individual has uncontrolled diabetes mellitus (Hemoglobin A1C>7) or diabetes withsignificant peripheral complications. (Uncontrolled diabetes will be ruled out byblood test excluding those with Hemoglobin A1C>7).

• Individual has an implantable neurostimulator, pacemaker, or implantable cardiacdefibrillator (ICD).

• Individual has been treated with onabotulinumtoxinA in the previous 9 months priorto enrollment, or more time if the principal investigator judges that thetherapeutic effect is present.

• Individual has been treated with percutaneous tibial nerve stimulation (PTNS) withinthe previous 4 weeks prior to enrollment or more time if the principal investigatorjudges that the therapeutic effect is present.

• Individual is currently using transcutaneous electrical nerve stimulation (TENS) inthe pelvic region, back, or legs.

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

• Individual has a clotting or bleeding disorder or is using anticoagulant therapiesand in the opinion of the investigator is not a good candidate for the study (antiplatelet and anticoagulant therapy may be continued or held at the discretionof the investigator).

• Individual is neutropenic or immune-compromised.

• Individual has had previous surgery and/or significant scarring at the implantlocation.

• Individual has ongoing dermatologic condition at the implant site, including but notlimited to dermatitis and autoimmune disorders.

• Individual has a clinically significant peripheral neuropathy in the lowerextremities.

• Individual has neurogenic bladder dysfunction.

• Individual has pitting edema at implant location (≥ 2+ is excluded).

• Individual has inadequate skin integrity or any evidence of an infection orinflammation in either lower leg.

• Individual has varicose veins and is symptomatic.

• Individual has open wounds, trauma, or prior surgery in the lower extremities.

• Individual has arterial disease in the lower extremities.

• Individual has vasculitis in the lower extremities.

• Individual has bladder stones or neoplasia. (Suspected bladder stones or neoplasiawill be ruled out with a urine dipstick showing no more than trace blood, andmicroscopic analysis (which should be done in that case) shows ≥3 PBC's /HPF unlessthat subject has been worked up and found negative for clinically significantdisease such as malignant neoplasm or stones.)

• In the opinion of the investigator, Individual is not a good candidate forparticipation in the study.