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

Exclusion Criteria34

• Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements.
• Individual has clinically significant bladder outlet obstruction. (Suspected bladder outlet obstruction will be initially assessed by uroflow study with those having a maximum flow rate < 15mL/s requiring additional evaluation.)
• Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on 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 with interstitial cystitis or bladder pain syndrome.
• Individual has abnormal post void residual (i.e. greater than 200 cc initially and on repeat testing after double voiding)
• Individual has clinically significant urethral stricture disease or bladder neck contracture. (Suspected disease or contracture will be initially assessed by uroflow study with those having a maximum flow rate < 15mL/s requiring additional evaluation.)
• 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 good candidate 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 last year.
• Individual is pregnant or intends to become pregnant during the study.
• Individual has the presence of urinary fistula, bladder stone, or interstitial cystitis.
• Individual has uncontrolled diabetes mellitus (Hemoglobin A1C>7) or diabetes with significant peripheral complications. (Uncontrolled diabetes will be ruled out by blood test excluding those with Hemoglobin A1C>7).
• Individual has an implantable neurostimulator, pacemaker, or implantable cardiac defibrillator (ICD).
• Individual has been treated with onabotulinumtoxinA in the previous 9 months prior to enrollment, or more time if the principal investigator judges that the therapeutic effect is present.
• Individual has been treated with percutaneous tibial nerve stimulation (PTNS) within the previous 4 weeks prior to enrollment or more time if the principal investigator judges that the therapeutic effect is present.
• Individual is currently using transcutaneous electrical nerve stimulation (TENS) in the pelvic region, back, or legs.
• Individual is aware that he or she will need an MRI scan other than a head/neck/shoulder MRI during the study period.
• Individual has a clotting or bleeding disorder or is using anticoagulant therapies and 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 discretion of the investigator).
• Individual is neutropenic or immune-compromised.
• Individual has had previous surgery and/or significant scarring at the implant location.
• Individual has ongoing dermatologic condition at the implant site, including but not limited to dermatitis and autoimmune disorders.
• Individual has a clinically significant peripheral neuropathy in the lower extremities.
• 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 or inflammation 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 neoplasia will be ruled out with a urine dipstick showing no more than trace blood, and microscopic analysis (which should be done in that case) shows ≥3 PBC's /HPF unless that subject has been worked up and found negative for clinically significant disease such as malignant neoplasm or stones.)
• In the opinion of the investigator, Individual is not a good candidate for participation in the study.