A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
- Conditions
- Urinary Urge IncontinenceOveractive BladderUrge IncontinenceIncontinence, Urinary
- Interventions
- Device: eCoin Tibial Nerve Stimulation
- Registration Number
- NCT05685433
- Lead Sponsor
- Valencia Technologies Corporation
- Brief 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).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description eCoin Tibial Nerve Stimulation eCoin Tibial Nerve Stimulation Subcutaneous stimulation of the tibial nerve using the eCoin device.
- Primary Outcome Measures
Name Time Method Responder Rate 12 months Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
Safety: 12 months rate of all device or procedure related AEs. 12 months Rate of all device or procedure related AEs.
- Secondary Outcome Measures
Name Time Method Responder Rate 24 months Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
Safety Data 24 months Rate of all device or procedure related AEs through 24 months post activation of eCoin.
Safety data through 7 months post-reimplantation. 7 months post reimplantation Rate of device or procedure-related AEs through 7 months post reimplantation.
Related Research Topics
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Trial Locations
- Locations (40)
UPNT Research Institute
🇺🇸Arlington, Texas, United States
The Emory Clinic
🇺🇸Atlanta, Georgia, United States
The Methodist Hospital Research Institute
🇺🇸Houston, Texas, United States
Cypress Medical Research
🇺🇸Wichita, Kansas, United States
Rush University
🇺🇸Chicago, Illinois, United States
Weill Cornell Medicine: Department of Urology
🇺🇸New York, New York, United States
USA Health
🇺🇸Mobile, Alabama, United States
Specialty Clinical Research of St. Louis
🇺🇸Saint Louis, Missouri, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Kansas Medical Center Research Institute, Inc
🇺🇸Kansas City, Kansas, United States
Minnesota Urology
🇺🇸Woodbury, Minnesota, United States
Southern Urogynecology
🇺🇸West Columbia, South Carolina, United States
Louisiana State University Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
The Oregon Clinic
🇺🇸Portland, Oregon, United States
Urology Centers of Alabama
🇺🇸Homewood, Alabama, United States
Arkansas Urology
🇺🇸Little Rock, Arkansas, United States
University of California, Irvine
🇺🇸Irvine, California, United States
AIR Research
🇺🇸Los Angeles, California, United States
Stanford Health
🇺🇸Stanford, California, United States
Urology Centers of Alabama
🇺🇸Homewood, Alabama, United States
USA Health
🇺🇸Mobile, Alabama, United States
Arkansas Urology
🇺🇸Little Rock, Arkansas, United States
University of California, Irvine
🇺🇸Irvine, California, United States
AIR Research
🇺🇸Los Angeles, California, United States
Stanford Health
🇺🇸Stanford, California, United States
The Emory Clinic
🇺🇸Atlanta, Georgia, United States
Rush University
🇺🇸Chicago, Illinois, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Kansas Medical Center Research Institute, Inc
🇺🇸Kansas City, Kansas, United States
Cypress Medical Research
🇺🇸Wichita, Kansas, United States
Louisiana State University Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Minnesota Urology
🇺🇸Woodbury, Minnesota, United States
Specialty Clinical Research of St. Louis
🇺🇸Saint Louis, Missouri, United States
Weill Cornell Medicine: Department of Urology
🇺🇸New York, New York, United States
The Oregon Clinic
🇺🇸Portland, Oregon, United States
Southern Urogynecology
🇺🇸West Columbia, South Carolina, United States
UPNT Research Institute
🇺🇸Arlington, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
The Methodist Hospital Research Institute
🇺🇸Houston, Texas, United States