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

Recruiting now · Not applicable

Conditions studied: Overactive Bladder, Urge Incontinence, Incontinence, Urinary, Urinary Urge Incontinence

In brief

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).

Key facts

Study ID

NCT05685433

Run by

Valencia Technologies Corporation

People needed

200

Starts

2023-01-26

Expected to finish

2031-12-01

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).
• 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.

Where it is running

• The Methodist Hospital Research Institute — Houston, Texas, United States (enrolling)
• UPNT Research Institute — Arlington, Texas, United States (enrolling)
• Baylor College of Medicine — Houston, Texas, United States (enrolling)
• Urology Centers of Alabama — Homewood, Alabama, United States (enrolling)
• Arkansas Urology — Little Rock, Arkansas, United States (enrolling)
• University of California, Irvine — Irvine, California, United States (enrolling)
• AIR Research — Los Angeles, California, United States (enrolling)
• Stanford Health — Stanford, California, United States (enrolling)
• Urological Research Network Corp — Hialeah, Florida, United States (enrolling)
• The Emory Clinic — Atlanta, Georgia, United States (enrolling)
• Rush University — Chicago, Illinois, United States (enrolling)
• The Iowa Clinic — Ankeny, Iowa, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• University of Kansas Medical Center Research Institute, Inc — Kansas City, Kansas, United States (enrolling)
• Cypress Medical Research — Wichita, Kansas, United States (enrolling)
• Minnesota Urology — Woodbury, Minnesota, United States (enrolling)
• Specialty Clinical Research of St. Louis — St Louis, Missouri, United States (enrolling)
• Weill Cornell Medicine: Department of Urology — New York, New York, United States (enrolling)
• Southern Urogynecology — West Columbia, South Carolina, United States (enrolling)
• USA Health — Mobile, Alabama, United States
• The Oregon Clinic — Portland, Oregon, United States
• Louisiana State University Health Sciences Center — Shreveport, Louisiana, United States

Full record on ClinicalTrials.gov

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