Effectiveness of eCoin at Sensory and Subsensory Amplitudes (ESSENCE)

Evaluating Effectiveness of Sensory and Subsensory Stimulation Amplitudes With eCoin® Tibial Nerve Stimulation in Urgency Urinary InContinence Episodes and Quality of Life

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Urge Incontinence
• Intervention / Treatment: Device: eCoin Peripheral Neurostimulator System

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jackie Dister; Phone Number: 7604294787; Email: jdister@valenciatechnologies.com

Study Locations

• United States
  • California
    • Downey, California, United States, 90241
      • Genesis Research
    • Fresno, California, United States, 93720
      • Urology Associates of Central California
  • Iowa
    • Ankeny, Iowa, United States, 50023
      • The Iowa Clinic
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Cypress Medical Research Center
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Adult & Pediatric Urology P.C.
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Associated Urologists of North Carolina
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Institute for Female Pelvic Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in UUI Episodes	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	3 months post-activation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Improvement from baseline of patient satisfaction with UUI symptoms as gathered from patient satisfaction surveys	2, 3 and 4 months post-activation
Reduction in UUI Episodes	Reduction from baseline in the number of urgency urinary incontinence episodes per day on a 3-day voiding diary (72 hours)	2 and 4 months post-activation
Quality of Life with OABq	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, 3 and 4 months post-activation

Collaborators and Investigators

• Sponsor: Valencia Technologies Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Neuromodulation; Stimulation; eCoin device; Tibial nerve
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence, Urge
• Other Study ID Numbers: 111-6133

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