A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
NCT ID: NCT05685433
Last Updated: 2025-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-01-26
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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eCoin Tibial Nerve Stimulation
Subcutaneous stimulation of the tibial nerve using the eCoin device.
eCoin Tibial Nerve Stimulation
Subcutaneous stimulation of the tibial nerve using the eCoin device.
Interventions
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eCoin Tibial Nerve Stimulation
Subcutaneous stimulation of the tibial nerve using the eCoin device.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Valencia Technologies Corporation
INDUSTRY
Responsible Party
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Locations
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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
Urological Research Network Corp
Hialeah, Florida, United States
The Emory Clinic
Atlanta, Georgia, United States
Rush University
Chicago, Illinois, United States
The Iowa Clinic
Ankeny, Iowa, 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
St 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
Countries
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Central Contacts
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Facility Contacts
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Alison Pickering, MD
Role: primary
Lauren Hendrix, MD
Role: primary
Dena Moskowitz, MD
Role: primary
John Kowalczyk, DO
Role: primary
Craig Comiter, MD
Role: primary
Sarah Adelstein, MD
Role: primary
Annah Vollstedt, MD
Role: primary
Kirk Redger, MD
Role: primary
Kevin Miller, MD
Role: primary
Michael Ehlert, MD
Role: primary
Travis Bullock, MD
Role: primary
Larissa Rodriguez, MD
Role: primary
Andrea Pezzella, MD
Role: primary
Tracy Cannon-Smith, MD
Role: primary
Christopher Smith, MD
Role: primary
Kathleen Kobashi, MD
Role: primary
Other Identifiers
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111-5702
Identifier Type: -
Identifier Source: org_study_id
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