Recruiting

eCoinA Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)

Sponsor:

Valencia Technologies Corporation

Code:

NCT05685433

Conditions

Overactive Bladder

Urge Incontinence

Incontinence, Urinary

Urinary Urge Incontinence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

eCoin Tibial Nerve Stimulation

Study Details

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).

Conditions

Overactive Bladder

Urge Incontinence

Incontinence, Urinary

Urinary Urge Incontinence

Study ID

NCT05685433

Start date

Jan 26, 2023

Status verified date

Apr, 2025

Completion date

Dec, 2031

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: eCoin Tibial Nerve Stimulation

Subcutaneous stimulation of the tibial nerve using the eCoin device.

Interventions

eCoin Tibial Nerve Stimulation

Subcutaneous stimulation of the tibial nerve using the eCoin device.

Primary outcome measure

Responder Rate [ Time Frame: 12 months ]
Safety: 12 months rate of all device or procedure related AEs. [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Dylan Beyer

8019207775 dbeyer@valenciatechnologies.com

Locations

Urology Centers of Alabama

Recruiting

Homewood, Alabama, United States, 35209

Arkansas Urology

Recruiting

Little Rock, Arkansas, United States, 72211

Principal Investigator:

Lauren Hendrix, MD

University of California, Irvine

Recruiting

Irvine, California, United States, 92697

Principal Investigator:

Dena Moskowitz, MD

AIR Research

Recruiting

Los Angeles, California, United States, 90017

Principal Investigator:

John Kowalczyk, DO

Stanford Health

Recruiting

Stanford, California, United States, 94305

Principal Investigator:

Craig Comiter, MD

Urological Research Network Corp

Recruiting

Hialeah, Florida, United States, 33016

Contacts

Isabel H Lopez, MBA

786-431-2014 isabel@besturology.net

Principal Investigator:

Edward Gheiler, MD

The Emory Clinic

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Mersiha Torlak

404-778-4823 mersiha.torlak@emory.edu

Principal Investigator:

Brendan Browne, MD

Rush University

Recruiting

Chicago, Illinois, United States, 60612

Principal Investigator:

Sarah Adelstein, MD

The Iowa Clinic

Recruiting

Ankeny, Iowa, United States, 50023

Contacts

Stephanie Morgan, MD

515-875-9815 spmorgan@iowaclinic.com

Principal Investigator:

Stephanie Morgan, MD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Principal Investigator:

Annah Vollstedt, MD

University of Kansas Medical Center Research Institute, Inc

Recruiting

Kansas City, Kansas, United States, 66160

Principal Investigator:

Kirk Redger, MD

Cypress Medical Research

Recruiting

Wichita, Kansas, United States, 67226

Principal Investigator:

Kevin Miller, MD

Minnesota Urology

Recruiting

Woodbury, Minnesota, United States, 55125

Principal Investigator:

Michael Ehlert, MD

Specialty Clinical Research of St. Louis

Recruiting

St Louis, Missouri, United States, 63141

Principal Investigator:

Travis Bullock, MD

Weill Cornell Medicine: Department of Urology

Recruiting

New York, New York, United States, 10065

Principal Investigator:

Larissa Rodriguez, MD

Southern Urogynecology

Recruiting

West Columbia, South Carolina, United States, 29169

Principal Investigator:

Andrea Pezzella, MD

UPNT Research Institute

Recruiting

Arlington, Texas, United States, 76017

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Christopher Smith, MD

The Methodist Hospital Research Institute

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Valencia Technologies Corporation

Last update posted

Jan 28, 2026

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Valencia Technologies Corporation on 2026-01-28.