Overactive BladderRECIPENCT05685433
A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
A study testing eCoin Tibial Nerve Stimulation in people with Overactive Bladder and Urge Incontinence, run by Valencia Technologies Corporation at 22 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder, Urge Incontinence, Incontinence, Urinary
- What is being tested?
- eCoin Tibial Nerve Stimulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 22 sitesUnited States
- Study dates
- 26 Jan 2023to Dec 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Individual is without pharmacological treatment of overactive bladder (anticholinergic and β3-adrenoceptor agonists) for 2 weeks prior to starting the baseline diary, 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.
Who cannot join
- 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.
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- 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 or trauma 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 RBC'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.
- Please Note: "lower extremities" refers to lower leg and foot.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
United States22 sites, 19 recruiting
- Recruiting
The Iowa Clinic
Ankeny, Iowa, 50023
Stephanie Morgan, MD, 515-875-9815, spmorgan@iowaclinic.com
Stephanie Morgan, MD
- Recruiting
UPNT Research Institute
Arlington, Texas, 76017
Tracy Cannon-Smith, MD
- Recruiting
The Emory Clinic
Atlanta, Georgia, 30322
Mersiha Torlak, 404-778-4823, mersiha.torlak@emory.edu
Brendan Browne, MD
- Recruiting
Rush University
Chicago, Illinois, 60612
Sarah Adelstein, MD
Sarah Adelstein, MD
- Recruiting
Urological Research Network Corp
Hialeah, Florida, 33016
Isabel H Lopez, MBA, 786-431-2014, isabel@besturology.net
Edward Gheiler, MD
- Recruiting
Urology Centers of Alabama
Homewood, Alabama, 35209
Alison Pickering, MD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Christopher Smith, MD
Christopher Smith, MD
- Recruiting
The Methodist Hospital Research Institute
Houston, Texas, 77030
Kathleen Kobashi, MD
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Annah Vollstedt, MD
Annah Vollstedt, MD
- Recruiting
University of California, Irvine
Irvine, California, 92697
Dena Moskowitz, MD
Dena Moskowitz, MD
- Recruiting
University of Kansas Medical Center Research Institute, Inc
Kansas City, Kansas, 66160
Kirk Redger, MD
Kirk Redger, MD
- Recruiting
Arkansas Urology
Little Rock, Arkansas, 72211
Lauren Hendrix, MD
Lauren Hendrix, MD
- Recruiting
AIR Research
Los Angeles, California, 90017
John Kowalczyk, DO
John Kowalczyk, DO
- Withdrawn
USA Health
Mobile, Alabama, 36606
- Recruiting
Weill Cornell Medicine: Department of Urology
New York, New York, 10065
Larissa Rodriguez, MD
Larissa Rodriguez, MD
- Active, not recruiting
The Oregon Clinic
Portland, Oregon, 97225
- Active, not recruiting
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71103
- Recruiting
Specialty Clinical Research of St. Louis
St Louis, Missouri, 63141
Travis Bullock, MD
Travis Bullock, MD
- Recruiting
Stanford Health
Stanford, California, 94305
Craig Comiter, MD
Craig Comiter, MD
- Recruiting
Southern Urogynecology
West Columbia, South Carolina, 29169
Andrea Pezzella, MD
Andrea Pezzella, MD
- Recruiting
Cypress Medical Research
Wichita, Kansas, 67226
Kevin Miller, MD
Kevin Miller, MD
- Recruiting
Minnesota Urology
Woodbury, Minnesota, 55125
Michael Ehlert, MD
Michael Ehlert, MD
About this study
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).
Read the 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.
- Being tested
- eCoin Tibial Nerve Stimulation
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eCoin Tibial Nerve StimulationDevice
Subcutaneous stimulation of the tibial nerve using the eCoin device.
| Study group | Role | What they receive |
|---|---|---|
| eCoin Tibial Nerve Stimulation | Experimental | Subcutaneous stimulation of the tibial nerve using the eCoin device. Receives: Device: eCoin Tibial Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Safety: 12 months rate of all device or procedure related AEs.
Rate of all device or procedure related AEs.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 24 months
Safety Data
Rate of all device or procedure related AEs through 24 months post activation of eCoin.
Measured: 24 months
Safety data through 7 months post-reimplantation.
Rate of device or procedure-related AEs through 7 months post reimplantation.
Measured: 7 months post reimplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start26 Jan 2023
- Primary completionApr 2028 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valencia Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685433
- Sponsor's protocol ID
- 111-5702
- Acronym
- RECIPE
- Status last verified
- Oct 2026
- First submitted
- 5 Jan 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes