Clinical trial NCT05882318: Effectiveness of eCoin at Sensory and Subsensory Amplitudes
Official title: Evaluating Effectiveness of Sensory and Subsensory Stimulation Amplitudes With eCoin® Tibial Nerve Stimulation in Urgency Urinary InContinence Episodes and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urge Incontinence
Keywords: Neuromodulation
eCoin device
Stimulation
Tibial nerve
Lead sponsor: Valencia Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2023-05-31
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Reduction in UUI Episodes
timeFrame: 3 months post-activation
Secondary outcomes:
measure: Quality of Life with OABq
timeFrame: 2, 3 and 4 months post-activation
measure: Patient Satisfaction
timeFrame: 2, 3 and 4 months post-activation
measure: Reduction in UUI Episodes
timeFrame: 2 and 4 months post-activation
Other outcomes:
Locations:
city: Downey
country: United States
facility: Genesis Research
state: California
city: Fresno
country: United States
facility: Urology Associates of Central California
state: California
city: Ankeny
country: United States
facility: The Iowa Clinic
state: Iowa
city: Wichita
country: United States
facility: Cypress Medical Research Center
state: Kansas
city: Omaha
country: United States
facility: Adult & Pediatric Urology P.C.
state: Nebraska
city: Raleigh
country: United States
facility: Associated Urologists of North Carolina
state: North Carolina
city: Allentown
country: United States
facility: Institute for Female Pelvic Medicine
state: Pennsylvania
Study officials:
References: