Effectiveness of eCoin at Sensory and Subsensory Amplitudes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-06

Study Completion Date

2024-05-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Urge Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sensory

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

Group Type EXPERIMENTAL

eCoin Peripheral Neurostimulator System

Intervention Type 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.

Subsensory

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

Group Type EXPERIMENTAL

eCoin Peripheral Neurostimulator System

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No