Effectiveness of eCoin at Sensory and Subsensory Amplitudes

Urge Incontinence Clinical Trial

— ESSENCE  

Official title:

Evaluating Effectiveness of Sensory and Subsensory Stimulation Amplitudes With eCoin® Tibial Nerve Stimulation in Urgency Urinary InContinence Episodes and Quality of Life

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05882318
• Other study ID #: 111-6133
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 6, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: Valencia Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: July 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, ß3-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)

Related Conditions & MeSH terms

• Urge Incontinence
• Urinary Incontinence, Urge

Intervention

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.

Locations

Country	Name	City	State
United States	Institute for Female Pelvic Medicine	Allentown	Pennsylvania
United States	The Iowa Clinic	Ankeny	Iowa
United States	Genesis Research	Downey	California
United States	Urology Associates of Central California	Fresno	California
United States	Adult & Pediatric Urology P.C.	Omaha	Nebraska
United States	Associated Urologists of North Carolina	Raleigh	North Carolina
United States	Cypress Medical Research Center	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Valencia Technologies Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in UUI Episodes	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	3 months post-activation
Secondary	Quality of Life with OABq	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.	2, 3 and 4 months post-activation
Secondary	Patient Satisfaction	Improvement from baseline of patient satisfaction with UUI symptoms as gathered from patient satisfaction surveys	2, 3 and 4 months post-activation
Secondary	Reduction in UUI Episodes	Reduction from baseline in the number of urgency urinary incontinence episodes per day on a 3-day voiding diary (72 hours)	2 and 4 months post-activation