eCoin for Urge Urinary Incontinence

(RECIPE Trial)

Recruiting at 21 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 tests a new implantable device called eCoin, which stimulates a nerve near the ankle to help manage urgency urinary incontinence (UUI). The goal is to determine if eCoin is safe and effective for individuals who experience sudden, strong urges to urinate due to an overactive bladder. Participants should frequently experience urgency urinary incontinence and have not responded well to other treatments, such as medications or certain types of nerve stimulation. As an unphased trial, this study provides participants the chance to contribute to innovative research that could lead to new treatment options for UUI.

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.

What prior data suggests that the eCoin device is safe for treating urgency urinary incontinence?

Research shows that patients generally tolerate the eCoin device well. Studies on its use for treating urgency urinary incontinence have shown it to be safe. The eCoin implant sends gentle electrical signals to a nerve in the leg, helping control the bladder.

In past studies, most patients did not experience serious side effects. Common mild side effects included pain or discomfort at the implant site. It's important to know that the eCoin device is MRI Conditional, so some MRI scans should be avoided for safety.

Overall, evidence suggests that the eCoin device is safe for most people, with manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for urge urinary incontinence, which often involve medications or behavioral therapies, eCoin offers a new approach by targeting the tibial nerve directly through subcutaneous stimulation. This innovative method could provide a more targeted and potentially longer-lasting relief by modulating nerve activity associated with bladder control. Researchers are excited about eCoin because it represents a non-pharmacological option that might reduce side effects and improve quality of life for patients who do not respond well to current therapies.

What evidence suggests that the eCoin device is effective for urgency urinary incontinence?

Research shows that the eCoin device effectively treats urgency urinary incontinence (UUI). In studies, people using eCoin experienced fewer UUI episodes. One study found that reusing eCoin improved bladder control. Another study showed that both the regular and gentle settings of eCoin reduced UUI episodes and enhanced quality of life. Overall, evidence suggests that eCoin is a safe and effective way to manage UUI. Participants in this trial will receive subcutaneous stimulation of the tibial nerve using the eCoin device to further evaluate its effectiveness. ^{1 5 6 7 8}

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

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

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

Individual has morbid obesity and in the opinion of the investigator is not a good candidate for the study

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]

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]

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]

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]

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]

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]

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/P200036B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The eCoin® Peripheral Neurostimulator is intended to be used to treat urgency urinary incontinence in patients intolerant to or having an ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05882318

Study Details | NCT05882318 | Effectiveness of eCoin at ... The eCoin device is a leadless, coin-sized tibial neurostimulator for treatment of urgency urinary incontinence. It emits a dome-shaped electrical field to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9071024/

Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial ... The reimplantation of eCoin was both safe and effective in treating UUI associated with overactive bladder syndrome. The demonstrated significant reduction ...

4. cureus.com cureus.com/articles/322499-a-prospective-study-on-the-effectiveness-of-sensory-and-sub-sensory-stimulation-amplitudes-using-ecoin-implantable-tibial-nerve-stimulation-in-reducing-urgency-urinary-incontinence-episodes-and-enhancing-quality-of-life

A Prospective Study on the Effectiveness of Sensory ... The ESSENCE study indicates that both sensory and sub-sensory amplitude settings of eCoin ITNS show a reduction in UUI episodes, improve quality ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05685433

NCT05685433 | A Real World Study of eCoin for Urgency ... Responder Rate, Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary. 12 ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/P200036C.pdf

eCoin® Peripheral Neurostimulator System Patient Manual Valencia Technologies performed a clinical study to determine the safety and effectiveness of the eCoin System in the treatment of urgency urinary incontinence ...

7. valenciatechnologies.com valenciatechnologies.com/safety-information/

Safety Information The eCoin Peripheral Neurostimulator is an MRI Conditional system. It is not safe to have a patient's lower leg placed in an MRI machine. Refer ...

8. urologyaustin.com urologyaustin.com/wp-content/uploads/2022/07/eCoin-Patient-Information.pdf

eCoin-Patient-Information.pdf Treat your Urge Urinary Incontinence leakage automatically. Urge Urinary Incontinence affects an astounding 53.3% of women in the United States.3 UUI is the ...