Effectiveness of eCoin at Sensory and Subsensory Amplitudes

NCT05882318 | Completed Results FDA Device

• 1 other identifier: 111-6133
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 7

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. After 3 months, subjects will be unblinded and reprogramming will be offered. Subjects will be followed for an additional month to a total of 4 months.

Conditions

Urge Incontinence

Keywords

Neuromodulation; eCoin device; Stimulation; Tibial nerve

Outcome Measures

Primary Outcomes (1)

• Change in UUI Episodes Per Day

  The primary endpoint is to explore the effect of two different eCoin amplitude settings on the change of UUI episodes per day on a 3-day voiding diary. A negative number shows a reduction in UUI episodes per day which means symptoms have improved since baseline. A positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline.

  3 months post-activation

Secondary Outcomes (4)

• Change in UUI Episodes Per Day

  2 months post-activation

• Change in UUI Episodes Per Day

  4 months post-activation

• Change in Overactive Bladder Health Related Quality of Life (HRQL)

  2 and 3 months post-activation

• Change in Overactive Bladder Health Related Quality of Life (HRQL)

  4 months post-activation

Study Arms (2)

Sensory

EXPERIMENTAL

Participants in the sensory treatment arm will be programmed to their sensory threshold.

Device: eCoin Peripheral Neurostimulator System

Subsensory

EXPERIMENTAL

Participants in the subsensory treatment arm will be programmed to approximately 75% of their sensory threshold.

Device: eCoin Peripheral Neurostimulator System

Interventions

eCoin Peripheral Neurostimulator System DEVICE

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.

Sensory; Subsensory

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual with diagnosis of overactive bladder with urgency urinary incontinence - daily UUI with a predominantly urgency component
• 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.

You may not qualify if:

• Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements.
• Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress).
• Individual has clinically significant bladder outlet obstruction.
• 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.
• Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome that is actively being managed.
• Individual has post void residual greater than 200 cc.
• Individual has an active diagnosis of bladder, urethral, or prostate cancer.
• Individual has had a prior anti-stress incontinence surgery within the last year.
• Individual has uncontrolled diabetes mellitus (Hemoglobin A1C\>7).
• Individual is neutropenic or immune-compromised.
• Individual has lower extremity pathology such as:
• Previous surgery and/or significant scarring at the planned implant location
• Ongoing dermatologic condition at the implant site, including but not limited to dermatitis and autoimmune disorders
• Clinically significant peripheral neuropathy in the lower extremities
• Pitting edema at the implant location (≥ 2+ is excluded)

Sponsors & Collaborators

• Valencia Technologies Corporation: lead

Study Sites (7)

Genesis Research

Downey, California, 90241, United States

Location

Urology Associates of Central California

Fresno, California, 93720, United States

Location

The Iowa Clinic

Ankeny, Iowa, 50023, United States

Location

Cypress Medical Research Center

Wichita, Kansas, 67226, United States

Location

Adult & Pediatric Urology P.C.

Omaha, Nebraska, 68114, United States

Location

Associated Urologists of North Carolina

Raleigh, North Carolina, 27612, United States

Location

Institute for Female Pelvic Medicine

Allentown, Pennsylvania, 18103, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

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; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dylan Beyer
• Organization: Valencia Technologies

dbeyer@valenciatechnologies.com

+1 (661) 775-1414

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 31, 2023
• Study Start: June 6, 2023
• Primary Completion: April 19, 2024
• Study Completion: May 14, 2024
• Last Updated: November 3, 2025
• Results First Posted: November 3, 2025

Record last verified: 2025-09

Locations

US (7)