A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
RECIPE
1 other identifier
interventional
200
1 country
22
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2023
CompletedFirst Posted
Study publicly available on registry
January 17, 2023
CompletedStudy Start
First participant enrolled
January 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2031
January 28, 2026
April 1, 2025
4.1 years
January 5, 2023
January 26, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Responder Rate
Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
12 months
Safety: 12 months rate of all device or procedure related AEs.
Rate of all device or procedure related AEs.
12 months
Secondary Outcomes (3)
Responder Rate
24 months
Safety Data
24 months
Safety data through 7 months post-reimplantation.
7 months post reimplantation
Other Outcomes (14)
Proportion of responders (50% improvement) after 12, 24, 36, 48, and 60 months of therapy.
12, 24, 36, 48, and 60 months
Proportion of responders (75% improvement) after 12, 24, 36, 48, and 60 months of therapy.
12, 24, 36, 48, and 60 months
Proportion of responders (100% improvement) after 12, 24, 36, 48, and 60 months of therapy.
12, 24, 36, 48, and 60 months
- +11 more other outcomes
Study Arms (1)
eCoin Tibial Nerve Stimulation
EXPERIMENTALSubcutaneous stimulation of the tibial nerve using the eCoin device.
Interventions
Subcutaneous stimulation of the tibial nerve using the eCoin device.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Urology Centers of Alabama
Homewood, Alabama, 35209, United States
USA Health
Mobile, Alabama, 36606, United States
Arkansas Urology
Little Rock, Arkansas, 72211, United States
University of California, Irvine
Irvine, California, 92697, United States
AIR Research
Los Angeles, California, 90017, United States
Stanford Health
Stanford, California, 94305, United States
Urological Research Network Corp
Hialeah, Florida, 33016, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Rush University
Chicago, Illinois, 60612, United States
The Iowa Clinic
Ankeny, Iowa, 50023, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center Research Institute, Inc
Kansas City, Kansas, 66160, United States
Cypress Medical Research
Wichita, Kansas, 67226, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71103, United States
Minnesota Urology
Woodbury, Minnesota, 55125, United States
Specialty Clinical Research of St. Louis
St Louis, Missouri, 63141, United States
Weill Cornell Medicine: Department of Urology
New York, New York, 10065, United States
The Oregon Clinic
Portland, Oregon, 97225, United States
Southern Urogynecology
West Columbia, South Carolina, 29169, United States
UPNT Research Institute
Arlington, Texas, 76017, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
The Methodist Hospital Research Institute
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2023
First Posted
January 17, 2023
Study Start
January 26, 2023
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
December 1, 2031
Last Updated
January 28, 2026
Record last verified: 2025-04