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MD",{"name":312,"role":67,"phone":18,"phoneExt":18,"email":18},{"facility":315,"status":28,"city":303,"state":291,"zip":304,"country":32,"countryCode":33,"cosmosGeoPoint":316,"geoPoint":318,"contacts":319},"The Methodist Hospital Research Institute",{"type":35,"coordinates":317},[307,308],{"lat":308,"lon":307},[320],{"name":321,"role":22,"phone":18,"phoneExt":18,"email":18},"Kathleen Kobashi, MD",{"type":323,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100491922","a-real-world-study-of-ecoin-for-urgency-urinary-incontinence-post-approval-evaluation-recipe-100491922",false,"NCT05685433","A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)","RECIPE","Inclusion Criteria:\n\n* Women and men above 18 years old with gender percentages reflective of disease prevalence in the U.S. population\n* Individual with diagnosis of overactive bladder with urgency urinary incontinence.\n* Individual has at least one urgency urinary incontinence episode on each of three days as determined on a 3-day voiding diary.\n* Individual gives written informed consent.\n* Individual is mentally competent and able to understand all study requirements.\n* Individual is willing and able to complete a 3-day voiding diary and quality of life questionnaire.\n* Individual is without pharmacological treatment of overactive bladder (anticholinergic and β3-adrenoceptor agonists) for 2 weeks prior to baseline or longer if the physician judges that the therapeutic effect is still present.\n* Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or who have undergone percutaneous tibial nerve stimulation (PTNS).\n* Individual is determined to be a suitable surgical candidate by physician.\n* Individual is appropriate for eCoin treatment based on the US FDA-approved IFU requirements.\n\nExclusion Criteria:\n\n* Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements.\n* 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 \\\u003C 15mL\u002Fs requiring additional evaluation.)\n* Individual has predominantly stress urinary incontinence (greater than 1\u002F3 of leaks on baseline diary are stress).\n* Individual has an active urinary tract infection at time of enrollment.\n* Individual has known polyuria.\n* Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome.\n* Individual has abnormal post void residual (i.e. greater than 200 cc initially and on repeat testing after double voiding)\n* 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 \\\u003C 15mL\u002Fs requiring additional evaluation.)\n* Individual has chronic venous insufficiency with a history of skin change (hyperpigmentation, lipodermatosclerosis, ulceration) in the ankle region.\n* Individual has morbid obesity and in the opinion of the investigator is not a good candidate for the study.\n* Individual has had diagnosis of bladder, urethral, or prostate cancer.\n* Individual has had a prior anti-stress incontinence sling surgery within the last year.\n* Individual is pregnant or intends to become pregnant during the study.\n* Individual has the presence of urinary fistula, bladder stone, or interstitial cystitis.\n* 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).\n* Individual has an implantable neurostimulator, pacemaker, or implantable cardiac defibrillator (ICD).\n* 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.\n* 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.\n* Individual is currently using transcutaneous electrical nerve stimulation (TENS) in the pelvic region, back, or legs.\n* Individual is aware that he or she will need an MRI scan other than a head\u002Fneck\u002Fshoulder MRI during the study period.\n* 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).\n* Individual is neutropenic or immune-compromised.\n* Individual has had previous surgery and\u002For significant scarring at the implant location.\n* Individual has ongoing dermatologic condition at the implant site, including but not limited to dermatitis and autoimmune disorders.\n* Individual has a clinically significant peripheral neuropathy in the lower extremities.\n* Individual has neurogenic bladder dysfunction.\n* Individual has pitting edema at implant location (≥ 2+ is excluded).\n* Individual has inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.\n* Individual has varicose veins and is symptomatic.\n* Individual has open wounds, trauma, or prior surgery in the lower extremities.\n* Individual has arterial disease in the lower extremities.\n* Individual has vasculitis in the lower extremities.\n* 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 \u002FHPF unless that subject has been worked up and found negative for clinically significant disease such as malignant neoplasm or stones.)\n* In the opinion of the investigator, Individual is not a good candidate for participation in the study.","ALL","18 Years",{"count":334,"type":335},200,"ESTIMATED","INTERVENTIONAL",[338],"NA","A prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the eCoin® implanted tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).",[341,342,343,344],"Overactive Bladder","Urge Incontinence","Incontinence, Urinary","Urinary Urge Incontinence","2026-01-26",{"date":347,"type":348},"2026-01-28","ACTUAL",{"date":350,"type":348},"2023-01-26",{"date":352,"type":335},"2031-12",{"name":5,"class":6},22]