eCoin for Urge Urinary Incontinence
(RECIPE Trial)
Trial Summary
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.
What data supports the effectiveness of the treatment eCoin for Urge Urinary Incontinence?
Is the eCoin device safe for treating urinary incontinence?
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.12456
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Implantation and Initial Treatment
Eligible subjects are implanted with the eCoin® tibial nerve stimulator and begin treatment
Extended Treatment and Monitoring
Continued monitoring of safety and effectiveness with follow-up visits through 5 years
Follow-up
Participants are monitored for long-term safety and effectiveness after treatment
Treatment Details
Interventions
- eCoin
eCoin is already approved in United States for the following indications:
- Urgency urinary incontinence in patients intolerant to or having an inadequate response to other more conservative treatments
Find a Clinic Near You
Who Is Running the Clinical Trial?
Valencia Technologies Corporation
Lead Sponsor