eCoin for Urge Urinary Incontinence

(RECIPE Trial)

Recruiting at 19 trial locations

Overseen By Craig Comiter, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Valencia Technologies Corporation

Must not be taking: Anticholinergics, β3-adrenoceptor agonists

Disqualifiers: Bladder obstruction, Stress incontinence, UTI, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants stop taking medications for overactive bladder, like anticholinergics and β3-adrenoceptor agonists, at least 2 weeks before starting the study. Other medications may be continued or stopped at the discretion of the investigator.

Is the eCoin device safe for treating urinary incontinence?

The eCoin device, a small implant placed in the lower leg, has been studied for safety in treating urinary incontinence. Research shows it is generally safe, with procedures done under local anesthesia and no major safety concerns reported in trials. ^{1 2 3 4 5}

How is the eCoin treatment different from other treatments for urge urinary incontinence?

The eCoin treatment is unique because it is a small, coin-sized device implanted in the lower leg to stimulate the tibial nerve, helping control bladder function. Unlike other treatments, it is minimally invasive, leadless, and operates automatically with a primary battery, offering a novel approach to managing urgency urinary incontinence. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment eCoin for Urge Urinary Incontinence?

Research shows that the eCoin, a small device implanted in the leg, has been effective in treating overactive bladder and urgency urinary incontinence, with studies demonstrating its safety and efficacy over periods of six months to a year. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Individual is appropriate for eCoin treatment based on the US FDA-approved IFU requirements

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

I've tried specific bladder treatments without success or couldn't tolerate them.

Exclusion Criteria

You have a lot of leftover urine in your bladder after going to the bathroom.

In the opinion of the investigator, Individual is not a good candidate for participation in the study

I currently have a urinary tract infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Treatment

Eligible subjects are implanted with the eCoin® tibial nerve stimulator and begin treatment

12 months

Regular follow-up visits to complete voiding diaries and questionnaires

Extended Treatment and Monitoring

Continued monitoring of safety and effectiveness with follow-up visits through 5 years

60 months

Follow-up visits at 12, 24, 36, 48, and 60 months

Follow-up

Participants are monitored for long-term safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• eCoin

Trial Overview 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.

How Is the Trial Designed?

Group I: eCoin Tibial Nerve Stimulation Experimental Treatment 1 Intervention

Subcutaneous stimulation of the tibial nerve using the eCoin device.

eCoin is already approved in United States for the following indications:

Approved in United States as eCoin Peripheral Neurostimulator for:

• Urgency urinary incontinence in patients intolerant to or having an inadequate response to other more conservative treatments

Who Is Running the Clinical Trial?

Valencia Technologies Corporation

Lead Sponsor

Trials

6

Recruited

450+

Published Research Related to This Trial

In a study involving 23 participants with refractory urgency urinary incontinence, reimplantation of the eCoin device showed a high efficacy, with 74% of participants responding positively at 12 weeks and 82% at 24 weeks, indicating significant symptom reduction.

The eCoin device was found to be safe, with no serious device-related adverse events reported, making it a convenient and maintainable option for treating overactive bladder syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence. Kaaki, B., English, S., Gilling, P., et al.[2022]

In a study of 46 participants with refractory urgency urinary incontinence, the eCoin device demonstrated significant efficacy, with 65% of participants experiencing a 50% or greater reduction in urgency episodes after 12 months, and 26% achieving complete continence.

The eCoin was found to be safe, with only one serious adverse event reported, indicating that it can be a reliable treatment option for patients suffering from overactive bladder syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twelve-month Durability of a Fully-implanted, Nickel-sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence: A Single-Arm, Prospective Study. Gilling, P., Meffan, P., Kaaki, B., et al.[2022]

Peripheral electrical nerve stimulation significantly improves urodynamic outcomes in patients with neurogenic lower urinary tract dysfunction (NLUTD), as shown in a systematic review of 10 studies involving 464 subjects, with notable improvements in maximum cystometric capacity and voided volume.

The treatment is considered safe, with only minor side effects like surface redness and swelling reported, and no severe adverse events, although further large-scale randomized controlled trials are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of peripheral electrical nerve stimulation on improvements of urodynamics and voiding diary in patients with neurogenic lower urinary tract dysfunction: a systematic review and meta-analysis. Ge, Q., Xu, H., Fan, Z., et al.[2023]

In a study of seven women with overactive bladder (OAB) symptoms who did not respond to conventional treatments, a novel implantable electrostimulator significantly reduced urinary frequency by 40% and improved quality of life over an average follow-up of 14.5 months.

Five out of seven patients experienced complete cessation of leakage episodes due to urgency after the procedure, while the remaining two had a significant reduction in leakage episodes, indicating the efficacy of this electrostimulation technique for managing OAB symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel surgical technique for implanting a new electrostimulation system for treating female overactive bladder: a preliminary report. Nissenkorn, I., De Jong, PR.[2019]

The eCoin® leadless tibial nerve stimulator was shown to be effective in treating refractory urgency urinary incontinence, with 68% of participants experiencing a 50% or greater reduction in episodes after 48 weeks of therapy in a study involving 137 subjects.

The device was found to have a relatively low safety profile, with only 16% of implanted subjects reporting device-related adverse events over the course of the study, indicating it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pivotal Study of Leadless Tibial Nerve Stimulation with eCoin® for Urgency Urinary Incontinence: An Open-Label, Single Arm Trial. Rogers, A., Bragg, S., Ferrante, K., et al.[2021]

The eCoin® neuromodulation device, implanted in 46 participants with refractory urgency urinary incontinence, demonstrated a significant 71% reduction in daily episodes of incontinence after 3 months, indicating its efficacy in treating this condition.

The device was found to be safe, with only one serious adverse event related to wound care, which was resolved with treatment, suggesting minimal safety concerns associated with its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Fully Implanted, Nickel Sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence. MacDiarmid, S., Staskin, DR., Lucente, V., et al.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Twelve-month Durability of a Fully-implanted, Nickel-sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence: A Single-Arm, Prospective Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of peripheral electrical nerve stimulation on improvements of urodynamics and voiding diary in patients with neurogenic lower urinary tract dysfunction: a systematic review and meta-analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A novel surgical technique for implanting a new electrostimulation system for treating female overactive bladder: a preliminary report. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Pivotal Study of Leadless Tibial Nerve Stimulation with eCoin® for Urgency Urinary Incontinence: An Open-Label, Single Arm Trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a Fully Implanted, Nickel Sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence. [2019]