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

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).

Study Overview

• Status: Recruiting
• Conditions: Overactive Bladder; Urge Incontinence; Urinary Urge Incontinence; Incontinence, Urinary
• Intervention / Treatment: Device: eCoin Tibial Nerve Stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dylan Beyer; Phone Number: 8019207775; Email: dbeyer@valenciatechnologies.com

Study Locations

• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Recruiting
      • Urology Centers Of Alabama
      • Contact: Alison Pickering, MD
    • Mobile, Alabama, United States, 36606
      • Withdrawn
      • USA Health
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Recruiting
      • Arkansas Urology
      • Contact: Lauren Hendrix, MD
      • Principal Investigator: Lauren Hendrix, MD
  • California
    • Irvine, California, United States, 92697
      • Recruiting
      • University of California, Irvine
      • Contact: Dena Moskowitz, MD
      • Principal Investigator: Dena Moskowitz, MD
    • Los Angeles, California, United States, 90017
      • Recruiting
      • AIR Research
      • Principal Investigator: John Kowalczyk, DO
      • Contact: John Kowalczyk, DO
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford Health
      • Contact: Craig Comiter, MD
      • Principal Investigator: Craig Comiter, MD
  • Florida
    • Hialeah, Florida, United States, 33016
      • Recruiting
      • Urological Research Network Corp
      • Contact: Isabel H Lopez, MBA; Phone Number: 786-431-2014; Email: isabel@besturology.net
      • Principal Investigator: Edward Gheiler, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • The Emory Clinic
      • Contact: Mersiha Torlak; Phone Number: 404-778-4823; Email: mersiha.torlak@emory.edu
      • Principal Investigator: Brendan Browne, MD
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University
      • Contact: Sarah Adelstein, MD
      • Principal Investigator: Sarah Adelstein, MD
  • Iowa
    • Ankeny, Iowa, United States, 50023
      • Recruiting
      • The Iowa Clinic
      • Contact: Stephanie Morgan, MD; Phone Number: 515-875-9815; Email: spmorgan@iowaclinic.com
      • Principal Investigator: Stephanie Morgan, MD
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa
      • Contact: Annah Vollstedt, MD
      • Principal Investigator: Annah Vollstedt, MD
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center Research Institute, Inc
      • Contact: Kirk Redger, MD
      • Principal Investigator: Kirk Redger, MD
    • Wichita, Kansas, United States, 67226
      • Recruiting
      • Cypress Medical Research
      • Principal Investigator: Kevin Miller, MD
      • Contact: Kevin Miller, MD
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Active, not recruiting
      • Louisiana State University Health Sciences Center
  • Minnesota
    • Woodbury, Minnesota, United States, 55125
      • Recruiting
      • Minnesota Urology
      • Principal Investigator: Michael Ehlert, MD
      • Contact: Michael Ehlert, MD
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Recruiting
      • Specialty Clinical Research of St. Louis
      • Principal Investigator: Travis Bullock, MD
      • Contact: Travis Bullock, MD
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine: Department of Urology
      • Contact: Larissa Rodriguez, MD
      • Principal Investigator: Larissa Rodriguez, MD
  • Oregon
    • Portland, Oregon, United States, 97225
      • Active, not recruiting
      • The Oregon Clinic
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Recruiting
      • Southern Urogynecology
      • Contact: Andrea Pezzella, MD
      • Principal Investigator: Andrea Pezzella, MD
  • Texas
    • Arlington, Texas, United States, 76017
      • Recruiting
      • UPNT Research Institute
      • Contact: Tracy Cannon-Smith, MD
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Principal Investigator: Christopher Smith, MD
      • Contact: Christopher Smith, MD
    • Houston, Texas, United States, 77030
      • Recruiting
      • The Methodist Hospital Research Institute
      • Contact: Kathleen Kobashi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eCoin Tibial Nerve Stimulation; Subcutaneous stimulation of the tibial nerve using the eCoin device.	Device: eCoin Tibial Nerve Stimulation; Subcutaneous stimulation of the tibial nerve using the eCoin device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety data through 7 months post-reimplantation.	Rate of device or procedure-related AEs through 7 months post reimplantation.	7 months post reimplantation
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.	24 months
Safety Data	Rate of all device or procedure related AEs through 24 months post activation of eCoin.	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of responders (50% improvement) after 12, 24, 36, 48, and 60 months of therapy.	Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.	12, 24, 36, 48, and 60 months
Proportion of responders (75% improvement) after 12, 24, 36, 48, and 60 months of therapy.	Proportion of subjects achieving at least a 75% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.	12, 24, 36, 48, and 60 months
Proportion of responders (100% improvement) after 12, 24, 36, 48, and 60 months of therapy.	Proportion of subjects achieving at least a 100% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.	12, 24, 36, 48, and 60 months
Reduction in the number of urgency urinary incontinence episodes.	Reduction in the number of urgency urinary incontinence episodes on a 3-day voiding diary.	12, 24, 36, 48, and 60 months
Reduction in the number of urgency urinary incontinence episodes for subjects with 8+ voids per day at baseline.	Reduction in the number of urgency urinary incontinence episodes on a 3-day voiding diary for subjects who experience more than 8 voids per day at baseline.	12, 24, 36, 48, and 60 months
Reduction in urgency episodes.	Reduction in the number of urgency episodes on a 3-day voiding diary.	12, 24, 36, 48, and 60 months
Reduction in nocturia episodes	Reduction in nocturia episodes on a 3-day voiding diary.	12, 24, 36, 48, and 60 months
Patient reported qualify of life	Improvement in patient reported qualify of life utilizing the Overactive Bladder Symptom Quality of Life Questionnaire (OABq).	12, 24, 36, 48, and 60 months
Patient reported overactive bladder condition improvement.	Improvement in patient reported overactive bladder condition utilizing the Patient Global Impression of Improvement (PGI-I) questionnaire.	12, 24, 36, 48, and 60 months
Patient reported sexual health.	Assess patient reported sexual health using the PROMIS Sexual Function and Satisfaction survey.	12 months
Patient reported satisfaction with eCoin.	Assess patient-reported satisfaction with eCoin therapy using the custom patient satisfaction rating survey.	12, 24, 36, 48, and 60 months
Device-related adverse events from implantation.	Rate of device-related adverse events from implantation.	12, 24, 36, 48, and 60 months
Procedure-related adverse events from implantation.	Rate of procedure-related adverse events from implantation.	12, 24, 36, 48, and 60 months
Procedure-related adverse events due to suture technique	Rate of procedure-related adverse events occurring as a result of inappropriate suture technique.	12, 24, 36, 48, and 60 months

Collaborators and Investigators

• Sponsor: Valencia Technologies Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge
• Other Study ID Numbers: 111-5702

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No