What is the mechanism of action of this treatment?

The most common treatments for Urge Incontinence include pharmacological agents like antimuscarinics and beta-3 adrenergic agonists, as well as neuromodulation techniques such as sacral nerve stimulation and percutaneous tibial nerve stimulation. Neuromodulation works by modulating the neural pathways that control bladder function, thereby reducing involuntary bladder contractions that cause urgency. This is particularly important for Urge Incontinence patients as it directly addresses the neural dysregulation contributing to their symptoms, potentially offering significant relief and improving quality of life. The eCoin device, a form of neuromodulation, aims to achieve similar outcomes by providing targeted electrical stimulation to the nerves involved in bladder control.

What side effects are associated with this type of intervention?

Neuromodulation treatments for urge incontinence, such as posterior tibial nerve stimulation (PTNS) and sacral nerve stimulation (SNS), are generally well-tolerated but can have side effects. Common side effects include mild pain or discomfort at the stimulation site, skin irritation, and temporary changes in bowel or bladder function. Severe adverse effects are rare but can include infection, bleeding, or hardware malfunctions. Adjusting the stimulation parameters often resolves most stimulation-related complications.

What prior FDA approvals exist?

The FDA has approved several treatments for urge incontinence, including pharmacological options like antimuscarinics (e.g., oxybutynin, tolterodine) and beta-3 adrenergic agonists (e.g., mirabegron). Neuromodulation therapies, such as sacral nerve stimulation (InterStim) and percutaneous tibial nerve stimulation (PTNS), have also received FDA approval. These neuromodulation treatments aim to regulate nerve signals to the bladder, similar to the mechanism being studied with the eCoin device.

What other types of research exist?

Promising alternatives to eCoin for urge incontinence include sacral nerve stimulation (SNS), which involves placing a small wire under the skin to send electrical pulses to nerves controlling the bladder. Another option is percutaneous tibial nerve stimulation (PTNS), which uses a needle electrode near the ankle to modulate bladder function. Both methods have shown efficacy in reducing symptoms of urge incontinence.

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Device

eCoin Neurostimulation for Urge Incontinence (ESSENCE Trial)

N/A

Waitlist Available

Research Sponsored by Valencia Technologies Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individual with diagnosis of overactive bladder with urgency urinary incontinence - daily UUI with a predominantly urgency component

Be older than 18 years old

Must not have

Individual has uncontrolled diabetes mellitus (Hemoglobin A1C>7)

Individual is neutropenic or immune-compromised

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2, 3 and 4 months post-activation

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the eCoin device, a small implant that sends electrical signals to help control bladder function, in people with urge urinary incontinence (UUI). It aims to see if the device can reduce urgent urination episodes. The eCoin is a leadless tibial nerve stimulator implanted in the lower leg to treat urgency urinary incontinence.

Who is the study for?

This trial is for individuals with overactive bladder and daily urge urinary incontinence who haven't had adequate relief from standard treatments. Candidates must be suitable for surgery but can't join if they've had certain prior surgeries, need MRI scans outside the head/neck area, have neurogenic bladder issues, immune deficiencies, uncontrolled diabetes, or conditions that could interfere with the eCoin device.

What is being tested?

The study tests the eCoin Peripheral Neurostimulator System's effectiveness on reducing urge urinary incontinence episodes. Participants will receive an implant and be randomly assigned to either sensory or subsensory stimulation groups to compare outcomes after three months of therapy.

What are the potential side effects?

Potential side effects are not explicitly listed in the provided information. However, as with any surgical procedure and device implantation, there may be risks such as infection at the implant site, discomfort or pain related to stimulation, skin irritation or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have overactive bladder with daily urgency to urinate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My diabetes is not under control (A1C>7).

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I have a weakened immune system.

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I have leg issues like previous surgery scars, skin conditions, nerve pain, swelling, poor skin at the implant site, severe varicose veins, open wounds, blood vessel problems, or skin changes due to poor blood flow in my legs.

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I currently have a UTI or had 4 or more UTIs in the past year.

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I have severe bladder pain or have been diagnosed with interstitial cystitis.

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I have a serious blockage in my bladder.

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I had surgery for stress incontinence in the last year.

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I have bladder control issues due to nerve problems.

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Most of my urine leaks happen when I cough, sneeze, or exercise.

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I have been diagnosed with cancer of the bladder, urethra, or prostate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2, 3 and 4 months post-activation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2, 3 and 4 months post-activation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2, 3 and 4 months post-activation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Patient Satisfaction

Quality of Life with OABq

Reduction in UUI Episodes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: SubsensoryExperimental Treatment1 Intervention

Group II: SensoryExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

eCoin Peripheral Neurostimulator System

2023

N/A

~50

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Urge Incontinence include pharmacological agents like antimuscarinics and beta-3 adrenergic agonists, as well as neuromodulation techniques such as sacral nerve stimulation and percutaneous tibial nerve stimulation. Neuromodulation works by modulating the neural pathways that control bladder function, thereby reducing involuntary bladder contractions that cause urgency. This is particularly important for Urge Incontinence patients as it directly addresses the neural dysregulation contributing to their symptoms, potentially offering significant relief and improving quality of life. The eCoin device, a form of neuromodulation, aims to achieve similar outcomes by providing targeted electrical stimulation to the nerves involved in bladder control.