Effectiveness of eCoin at Sensory and Subsensory Amplitudes (ESSENCE)

Valencia Technologies

Status

Completed

Conditions

Urge Incontinence

Treatments

Device: eCoin Peripheral Neurostimulator System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05882318

111-6133

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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:
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
Individual has neurogenic bladder dysfunction.
Individual is aware that he or she will need an MRI scan other than a head/neck/shoulder MRI during the study period.
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)