Urge IncontinenceESSENCENCT05882318
Effectiveness of eCoin at Sensory and Subsensory Amplitudes
A study testing eCoin Peripheral Neurostimulator System in people with Urge Incontinence, run by Valencia Technologies Corporation at 7 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urge Incontinence
- What is being tested?
- eCoin Peripheral Neurostimulator System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 Jun 2023to 14 May 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Institute for Female Pelvic Medicine
Allentown, Pennsylvania, 18103
The Iowa Clinic
Ankeny, Iowa, 50023
Genesis Research
Downey, California, 90241
Urology Associates of Central California
Fresno, California, 93720
Adult & Pediatric Urology P.C.
Omaha, Nebraska, 68114
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612
Cypress Medical Research Center
Wichita, Kansas, 67226
About this study
Official title: Evaluating Effectiveness of Sensory and Subsensory Stimulation Amplitudes With eCoin® Tibial Nerve Stimulation in Urgency Urinary InContinence Episodes and Quality of Life
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
- Being tested
- eCoin Peripheral Neurostimulator System
- Keywords
- Neuromodulation, eCoin device, Stimulation, Tibial nerve
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eCoin Peripheral Neurostimulator SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sensory | Experimental | Participants in the sensory treatment arm will be programmed to their sensory threshold. Receives: Device: eCoin Peripheral Neurostimulator System |
| Subsensory | Experimental | Participants in the subsensory treatment arm will be programmed to approximately 75% of their sensory threshold. Receives: Device: eCoin Peripheral Neurostimulator System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-activation
Secondary outcomes (4)
Change in UUI Episodes Per Day
Change in the number of urgency urinary incontinence episodes per day on a 3-day voiding diary.
A negative number shows a reduction in UUI episodes 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.
Measured: 2 months post-activation
Change in UUI Episodes Per Day
A secondary endpoint is to explore the change in 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.
Measured: 4 months post-activation
Change in Overactive Bladder Health Related Quality of Life (HRQL)
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.
Higher scores on the HRQL portion indicate better quality of life. The maximum HRQL domain score is 100 (best) and the minimum HRQL score is 0 (worst).
A positive change in score indicates an improvement in quality of life.
Measured: 2 and 3 months post-activation
Change in Overactive Bladder Health Related Quality of Life (HRQL)
Change from baseline in patient reported quality of life as assessed by the Health Related Quality of Life (HRQL) portion of the Overactive Bladder questionnaire (OABq) survey.
Higher scores on the HRQL indicate better quality of life. The maximum HRQL domain score is 100 (best) and the minimum HRQL score is 0 (worst).
A positive change in score indicates an improvement in quality of life.
Measured: 4 months post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start6 Jun 2023
- Primary completion19 Apr 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urge IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valencia Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882318
- Sponsor's protocol ID
- 111-6133
- Acronym
- ESSENCE
- Status last verified
- Sep 2025
- First submitted
- 19 May 2023
- Last updated
- 3 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes