ESSENCE: Effectiveness of eCoin at Sensory and Subsensory Amplitudes
Study Details
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 |
|---|---|---|
|
N/A |
Study Design
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
- Reduction in UUI Episodes [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
- Quality of Life with OABq [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
- Patient Satisfaction [2, 3 and 4 months post-activation]
Improvement from baseline of patient satisfaction with UUI symptoms as gathered from patient satisfaction surveys
- Reduction in UUI Episodes [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
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:
-
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)
-
Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg
-
Moderate to severe varicose veins
-
Open wounds or recent trauma
-
Arterial and/or vasculitis disease in the lower extremities
-
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)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Valencia Technologies Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 111-6133