Effectiveness of eCoin at Sensory and Subsensory Amplitudes

Not Applicable

Completed

• Conditions: Urge Incontinence
• Interventions: Device: eCoin Peripheral Neurostimulator System

• Registration Number: NCT05882318
• Lead Sponsor: Valencia Technologies Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-19
• Study First Posted: 2023-05-31
• Study Start: 2023-06-06
• Primary Completion: 2024-04-19
• Study Completion: 2024-05-14
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sensory	eCoin Peripheral Neurostimulator System	-
Subsensory	eCoin Peripheral Neurostimulator System	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
Patient Satisfaction	2, 3 and 4 months post-activation	Improvement from baseline of patient satisfaction with UUI symptoms as gathered from patient satisfaction surveys
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; Higher scores on the HRQL portion indicate better quality of life.

Trial Locations

Locations (7)

Genesis Research; 🇺🇸 Downey, California, United States

Urology Associates of Central California; 🇺🇸 Fresno, California, United States

The Iowa Clinic; 🇺🇸 Ankeny, Iowa, United States

Associated Urologists of North Carolina; 🇺🇸 Raleigh, North Carolina, United States

Adult & Pediatric Urology P.C.; 🇺🇸 Omaha, Nebraska, United States

Institute for Female Pelvic Medicine; 🇺🇸 Allentown, Pennsylvania, United States

Cypress Medical Research Center; 🇺🇸 Wichita, Kansas, United States