Effectiveness of eCoin at Sensory and Subsensory Amplitudes (ESSENCE)

• ClinicalTrials.gov Identifier: NCT05882318
• Recruitment Status: Active, not recruiting
• First Posted: May 31, 2023
• Last Update Posted: January 18, 2024
• Sponsor: Valencia Technologies Corporation
• Information provided by (Responsible Party): Valencia Technologies Corporation

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Locations

United States, California

Genesis Research

Downey, California, United States, 90241

Urology Associates of Central California

Fresno, California, United States, 93720

United States, Iowa

The Iowa Clinic

Ankeny, Iowa, United States, 50023

United States, Kansas

Cypress Medical Research Center

Wichita, Kansas, United States, 67226

United States, Nebraska

Adult & Pediatric Urology P.C.

Omaha, Nebraska, United States, 68114

United States, North Carolina

Associated Urologists of North Carolina

Raleigh, North Carolina, United States, 27612

United States, Pennsylvania

Institute for Female Pelvic Medicine

Allentown, Pennsylvania, United States, 18103

Sponsors and Collaborators

Valencia Technologies Corporation

More Information

• Responsible Party: Valencia Technologies Corporation
• ClinicalTrials.gov Identifier: NCT05882318
• Other Study ID Numbers: 111-6133
• First Posted: May 31, 2023
• Last Update Posted: January 18, 2024
• Last Verified: January 2024

• 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:

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