What is the mechanism of action of this treatment?

The most common treatments for Urge Incontinence include pharmacological therapies, behavioral interventions, and neuromodulation techniques such as tibial nerve stimulation. Tibial nerve stimulation, like the eCoin® implanted tibial nerve stimulator, works by sending electrical impulses to the tibial nerve, which in turn modulates the neural pathways that control bladder function. This can help reduce the frequency and urgency of urination by improving the communication between the bladder and the brain. For patients with Urge Incontinence, this matters because it offers a minimally invasive option that can effectively manage symptoms and improve quality of life without the side effects associated with medications.

What side effects are associated with this type of intervention?

Tibial nerve stimulation, including devices like the eCoin® implanted tibial nerve stimulator, is generally considered safe for treating urgency urinary incontinence (UUI). Common side effects are typically mild and may include local pain or discomfort at the site of stimulation, redness, and minor bruising. Serious adverse events are rare. Other treatments for UUI, such as medications (anticholinergics and beta-3 agonists), can have side effects like dry mouth, constipation, blurred vision, and urinary retention.

What prior FDA approvals exist?

The FDA has approved several treatments for urge incontinence, including neuromodulation therapies. Sacral neuromodulation (SNM) devices, such as InterStim, have been approved for treating overactive bladder and urge incontinence by modulating the sacral nerves to improve bladder function. Additionally, percutaneous tibial nerve stimulation (PTNS) is another FDA-approved treatment that involves stimulating the tibial nerve to influence bladder activity. These therapies are similar to the eCoin® implanted tibial nerve stimulator being studied for its effectiveness in managing urgency urinary incontinence.

What other types of research exist?

One promising alternative to the eCoin® implanted tibial nerve stimulator for treating urge incontinence is the flexible neural clip (FNC). This novel device can interface with various peripheral nerves, including the pelvic nerve, and allows fine-tuning of physiological processes such as micturition. This flexibility and targeted approach make it a potential option for patients seeking new treatments in 2024.

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Tibial Nerve Stimulation

eCoin for Urge Urinary Incontinence (RECIPE Trial)

N/A

Recruiting

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 is mentally competent and able to understand all study requirements

Individual has at least one urgency urinary incontinence episode on each of three days as determined on a 3-day voiding diary

Must not have

Individual has an active urinary tract infection at time of enrollment

Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12, 24, 36, 48, and 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a small device called eCoin® that is placed under the skin near the ankle. It sends electrical signals to a nerve that helps control the bladder. The study focuses on people who have trouble controlling their bladder and experience sudden urges to urinate. The goal is to see if this device can safely and effectively reduce these symptoms over time. The eCoin is a nickel-sized, battery-powered device implanted in the lower leg to treat overactive bladder, and has been evaluated in previous studies for its safety and effectiveness.

Who is the study for?

This trial is for adults over 18 with urgency urinary incontinence who haven't had success with certain other treatments. Candidates should be able to track their bathroom visits and not be pregnant, have bladder cancer history, or severe conditions like uncontrolled diabetes that could affect the study.

What is being tested?

The eCoin Tibial Nerve Stimulation device is being tested for safety and effectiveness in treating overactive bladder symptoms. Participants will receive the implant and record their symptoms for a year to see if there's at least a 50% improvement.

What are the potential side effects?

Possible side effects may include discomfort at the implant site, skin irritation or infection, bleeding complications especially if on blood thinners, nerve-related issues in lower extremities, and potential interference with certain medical devices.

Eligibility Criteria

Inclusion Criteria

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

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I understand all the study requirements and can make decisions.

Select...

I've had sudden urges to urinate that I couldn't control, at least once a day for three days.

Select...

I have been diagnosed with an overactive bladder that causes sudden urges to urinate.

Exclusion Criteria

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

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I currently have a urinary tract infection.

Select...

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

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My diabetes is not under control, with an A1C level over 7.

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I have a urinary fistula, bladder stone, or interstitial cystitis.

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I have artery disease in my legs.

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I frequently urinate more than usual.

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I have long-term vein problems with skin changes near my ankle.

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I have skin issues or infections in my lower legs.

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I had surgery for stress incontinence less than a year ago.

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I have a skin condition like dermatitis at the planned surgery site.

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I have bladder control issues due to nerve problems.

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I have vasculitis in my legs.

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I am using a TENS unit for pain in my pelvic area, back, or legs.

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I have had surgery or significant scarring where the implant will be placed.

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I have open wounds or had surgery on my legs.

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

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I have painful varicose veins.

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I do not have severe swelling at the site of my implant.

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I have severe nerve pain or numbness in my legs.

Select...

I have a weakened immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12, 24, 36, 48, and 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12, 24, 36, 48, and 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12, 24, 36, 48, and 60 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Responder Rate

Safety

Secondary study objectives

Safety Data

Safety data through 7 months post-reimplantation.

Other study objectives

Device-related adverse events from implantation.

Patient reported overactive bladder condition improvement.

Patient reported qualify of life

+11 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: eCoin Tibial Nerve StimulationExperimental Treatment1 Intervention

Subcutaneous stimulation of the tibial nerve using the eCoin device.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

eCoin Tibial Nerve Stimulation

2018

N/A

~160

0 / 23Eligibility 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 therapies, behavioral interventions, and neuromodulation techniques such as tibial nerve stimulation. Tibial nerve stimulation, like the eCoin® implanted tibial nerve stimulator, works by sending electrical impulses to the tibial nerve, which in turn modulates the neural pathways that control bladder function. This can help reduce the frequency and urgency of urination by improving the communication between the bladder and the brain. For patients with Urge Incontinence, this matters because it offers a minimally invasive option that can effectively manage symptoms and improve quality of life without the side effects associated with medications.