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Effectiveness of eCoin at Sensory and Subsensory Amplitudes (ESSENCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05882318
Recruitment Status : Recruiting
First Posted : May 31, 2023
Last Update Posted : August 9, 2023
Sponsor:
Information provided by (Responsible Party):
Valencia Technologies Corporation

Study Description
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Brief Summary:

The goal of this prospective, multi-center, double-blinded randomized controlled is to learn about effectiveness and QOL with eCoin at two different amplitude settings in subjects with urge urinary incontincence (UUI). The main question it aims to answer is:

  • The reduction in UUI episodes per day on a 3-day voiding diary in both groups after 3 months of therapy

Participants will be implanted with the eCoin device and randomized to either a sensory or subsensory stimulation group and complete voiding diaries and patient reported-outcomes through 3 months of therapy.


Condition or disease Intervention/treatment Phase
Urge Incontinence Device: eCoin Peripheral Neurostimulator System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Effectiveness of Sensory and Subsensory Stimulation Amplitudes With eCoin® Tibial Nerve Stimulation in Urgency Urinary InContinence Episodes and Quality of Life
Actual Study Start Date : June 6, 2023
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sensory Device: eCoin Peripheral Neurostimulator System
The eCoin device is a leadless, coin-sized tibial neurostimulator for treatment of urgency urinary incontinence. It emits a dome-shaped electrical field to deliver low-duty cycle stimulation to the tibial nerve. The device is to be implanted under local anesthetic in the lower leg, and once activated delivers automatic 30-minute treatment sessions without the need for patient management.
Experimental: Subsensory Device: eCoin Peripheral Neurostimulator System
The eCoin device is a leadless, coin-sized tibial neurostimulator for treatment of urgency urinary incontinence. It emits a dome-shaped electrical field to deliver low-duty cycle stimulation to the tibial nerve. The device is to be implanted under local anesthetic in the lower leg, and once activated delivers automatic 30-minute treatment sessions without the need for patient management.


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in UUI Episodes [ Time Frame: 3 months post-activation ]
    The primary endpoint is to explore the effect of two different eCoin amplitude settings on the reduction of UUI episodes per day on a 3-day voiding diary


Secondary Outcome Measures :
  1. Quality of Life with OABq [ Time Frame: 2, 3 and 4 months post-activation ]

    Change from baseline in the patient reported quality of life as assessed by the Health Related Quality of Life (HRQL) portion of the Overactive Bladder questionnaire (OABq) survey

    Higher scores on the HRQL portion indicate better quality of life.


  2. Patient Satisfaction [ Time Frame: 2, 3 and 4 months post-activation ]
    Improvement from baseline of patient satisfaction with UUI symptoms as gathered from patient satisfaction surveys

  3. Reduction in UUI Episodes [ Time Frame: 2 and 4 months post-activation ]
    Reduction from baseline in the number of urgency urinary incontinence episodes per day on a 3-day voiding diary (72 hours)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Individual with diagnosis of overactive bladder with urgency urinary incontinence - daily UUI with a predominantly urgency component
  2. 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).
  3. Individual is determined to be a suitable surgical candidate by physician.

Key Exclusion Criteria:

  1. Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements.
  2. Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress).
  3. Individual has clinically significant bladder outlet obstruction.
  4. Individual has an active urinary tract infection at time of enrollment or has had four or more symptomatic UTI's in the last 12 months.
  5. Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome that is actively being managed.
  6. Individual has post void residual greater than 200 cc.
  7. Individual has an active diagnosis of bladder, urethral, or prostate cancer.
  8. Individual has had a prior anti-stress incontinence surgery within the last year.
  9. Individual has uncontrolled diabetes mellitus (Hemoglobin A1C>7).
  10. Individual is neutropenic or immune-compromised.

  11. Individual has lower extremity pathology such as:

    1. Previous surgery and/or significant scarring at the planned implant location
    2. Ongoing dermatologic condition at the implant site, including but not limited to dermatitis and autoimmune disorders
    3. Clinically significant peripheral neuropathy in the lower extremities
    4. Pitting edema at the implant location (≥ 2+ is excluded)
    5. Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg
    6. Moderate to severe varicose veins
    7. Open wounds or recent trauma
    8. Arterial and/or vasculitis disease in the lower extremities
    9. Chronic venous insufficiency with a history of skin change (hyperpigmentation, lipodermatosclerosis, ulceration) in the ankle region
  12. Individual has neurogenic bladder dysfunction.
  13. Individual is aware that he or she will need an MRI scan other than a head/neck/shoulder MRI during the study period.
  14. Any condition that, in the investigator's opinion, would preclude participation in the study (e.g., comorbidity that places subject at increased risk for surgical intervention, medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, such as morbid obesity, clotting or bleeding disorder)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05882318


Contacts
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Contact: Jackie Dister 7604294787 jdister@valenciatechnologies.com

Locations
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United States, California
Genesis Research Recruiting
Downey, California, United States, 90241
Contact: Alicia Buenrostro    562-923-0706    alicia.buenrostro@uniohp.com   
Principal Investigator: Pooya Banapour         
Urology Associates of Central California Recruiting
Fresno, California, United States, 93720
Contact: Kristin Santeufemia    559-321-2924    ksanteufemia@urologyassociates.net   
Principal Investigator: William Schiff, M.D.         
United States, Kansas
Cypress Medical Research Center Recruiting
Wichita, Kansas, United States, 67226
Contact: Addie Hayes, RN, CCRC    316-425-6333    addiehayes@cypressmrc.com   
Principal Investigator: Kevin Miller, MD         
United States, Nebraska
Adult & Pediatric Urology P.C. Recruiting
Omaha, Nebraska, United States, 68114
Contact: Amy Nelson       anelson@adultpediatricuro.com   
Principal Investigator: Rebecca McCrery, MD         
United States, North Carolina
Associated Urologists of North Carolina Recruiting
Raleigh, North Carolina, United States, 27612
Contact: Kip Moffett    919-758-8677    kmoffett@auncurology.com   
Principal Investigator: Mark Jalkut         
Sponsors and Collaborators
Valencia Technologies Corporation
More Information
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Responsible Party: Valencia Technologies Corporation
ClinicalTrials.gov Identifier: NCT05882318    
Other Study ID Numbers: 111-6133
First Posted: May 31, 2023    Key Record Dates
Last Update Posted: August 9, 2023
Last Verified: August 2023

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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
Keywords provided by Valencia Technologies Corporation:
Neuromodulation
eCoin device
Stimulation
Tibial nerve
Additional relevant MeSH terms:
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Urinary Incontinence, Urge
Urinary Incontinence
Urination Disorders
Urologic Diseases
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Lower Urinary Tract Symptoms
Urological Manifestations