a real world study of ecoin for urgency urinary incontinence: post approval evaluation (recipe)

Conditions: Overactive Bladder; Urge Incontinence; Incontinence, Urinary; Urinary Urge Incontinence

Summary: 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).

the goal of this prospective, multicenter, single-arm study is to assess the long-term safety and effectiveness of the fda approved ecoin® implanted tibial nerve stimulator in a real world setting. eligible subjects having overactive bladder (oab) with urgency urinary incontinence (uui) will be implanted with the ecoin® implanted tibial stimulator and complete voiding diaries and questionnaires at follow-up visits through 5 years.

Eligibility criteria:
inclusion criteria: * women and men above 18 years old with gender percentages reflective of disease prevalence 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 three days 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 life questionnaire. * 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. * 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). * individual is determined to be a suitable surgical candidate by physician. * individual is appropriate for ecoin treatment based on the us fda-approved ifu requirements. exclusion criteria: * 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.