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 Sex
- 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
Urology Centers of Alabama
Homewood 4067927, Alabama 4829764 35209
Homewood 4067927, Alabama 4829764 35209
Contact:
Alison Pickering, MD
Alison Pickering, MD
Arkansas Urology
Little Rock 4119403, Arkansas 4099753 72211
Little Rock 4119403, Arkansas 4099753 72211
Contact:
Lauren Hendrix, MD
Lauren Hendrix, MD
University of California, Irvine
Irvine 5359777, California 5332921 92697
Irvine 5359777, California 5332921 92697
Contact:
Dena Moskowitz, MD
Dena Moskowitz, MD
AIR Research
Los Angeles 5368361, California 5332921 90017
Los Angeles 5368361, California 5332921 90017
Contact:
John Kowalczyk, DO
John Kowalczyk, DO
Stanford Health
Stanford 5398563, California 5332921 94305
Stanford 5398563, California 5332921 94305
Contact:
Craig Comiter, MD
Craig Comiter, MD
Urological Research Network Corp
Hialeah 4158476, Florida 4155751 33016
Hialeah 4158476, Florida 4155751 33016
The Emory Clinic
Atlanta 4180439, Georgia 4197000 30322
Atlanta 4180439, Georgia 4197000 30322
Rush University
Chicago 4887398, Illinois 4896861 60612
Chicago 4887398, Illinois 4896861 60612
Contact:
Sarah Adelstein, MD
Sarah Adelstein, MD
The Iowa Clinic
Ankeny 4846960, Iowa 4862182 50023
Ankeny 4846960, Iowa 4862182 50023
University of Iowa
Iowa City 4862034, Iowa 4862182 52242
Iowa City 4862034, Iowa 4862182 52242
Contact:
Annah Vollstedt, MD
Annah Vollstedt, MD
University of Kansas Medical Center Research Institute, Inc
Kansas City 4273837, Kansas 4273857 66160
Kansas City 4273837, Kansas 4273857 66160
Contact:
Kirk Redger, MD
Kirk Redger, MD
Cypress Medical Research
Wichita 4281730, Kansas 4273857 67226
Wichita 4281730, Kansas 4273857 67226
Contact:
Kevin Miller, MD
Kevin Miller, MD
Minnesota Urology
Woodbury 5053358, Minnesota 5037779 55125
Woodbury 5053358, Minnesota 5037779 55125
Contact:
Michael Ehlert, MD
Michael Ehlert, MD
Specialty Clinical Research of St. Louis
St Louis 4407066, Missouri 4398678 63141
St Louis 4407066, Missouri 4398678 63141
Contact:
Travis Bullock, MD
Travis Bullock, MD
Weill Cornell Medicine: Department of Urology
New York 5128581, New York 5128638 10065
New York 5128581, New York 5128638 10065
Contact:
Larissa Rodriguez, MD
Larissa Rodriguez, MD
Southern Urogynecology
West Columbia 4600541, South Carolina 4597040 29169
West Columbia 4600541, South Carolina 4597040 29169
Contact:
Andrea Pezzella, MD
Andrea Pezzella, MD
UPNT Research Institute
Arlington 4671240, Texas 4736286 76017
Arlington 4671240, Texas 4736286 76017
Contact:
Tracy Cannon-Smith, MD
Tracy Cannon-Smith, MD
Baylor College of Medicine
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Contact:
Christopher Smith, MD
Christopher Smith, MD
The Methodist Hospital Research Institute
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Contact:
Kathleen Kobashi, MD
Kathleen Kobashi, MD
More Details
- NCT ID
- NCT05685433
- 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.