A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
Purpose
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).
Conditions
- Overactive Bladder
- Urge Incontinence
- Incontinence, Urinary
- Urinary Urge Incontinence
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental eCoin Tibial Nerve Stimulation |
Subcutaneous stimulation of the tibial nerve using the eCoin device. |
|
Recruiting Locations
University of Kansas Medical Center Research Institute, Inc
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Contact:
Kirk Redger, MD
Kirk Redger, MD
More Details
- Status
- Recruiting
- Sponsor
- Valencia Technologies Corporation
Detailed Description
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.