eCoin for Urge Urinary Incontinence (RECIPE Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Valencia Technologies Corporation
No Placebo Group
Approved in 1 jurisdiction
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.
What data supports the idea that eCoin for Urge Urinary Incontinence is an effective treatment?The available research shows that eCoin, a small device implanted in the lower leg, is effective for treating urge urinary incontinence. One study found that after one year of using eCoin, patients experienced significant improvements. Another study confirmed these positive results after six months, showing that the device is safe and effective. These studies suggest that eCoin is a promising treatment option for those with this condition.13456
Do I need to stop my current medications to join the trial?Yes, you need to stop taking medications for overactive bladder, like anticholinergics and β3-adrenoceptor agonists, at least 2 weeks before the trial starts. Other medications may be continued or stopped at the investigator's discretion.
Is the eCoin treatment a promising option for urge urinary incontinence?Yes, the eCoin treatment is promising for urge urinary incontinence. It is a small, battery-powered device implanted in the lower leg that helps control bladder issues. Studies show it is safe and effective, with positive results lasting up to a year.12345
What safety data exists for eCoin treatment for urinary incontinence?The safety of the eCoin device has been evaluated in several studies. A 12-month study assessed the safety and efficacy of the eCoin for treating urgency urinary incontinence, showing positive results. A six-month follow-up study on reimplantation also evaluated its safety and feasibility. Additionally, a pivotal trial focused on the safety and efficacy of the eCoin for treating refractory urgency urinary incontinence. These studies collectively provide safety data for the eCoin device.23456
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
I understand all the study requirements and can make decisions.
I've had sudden urges to urinate that I couldn't control, at least once a day for three days.
I have been diagnosed with an overactive bladder that causes sudden urges to urinate.
Exclusion Criteria
I currently have a urinary tract infection.
I have severe bladder pain or have been diagnosed with interstitial cystitis.
My diabetes is not under control, with an A1C level over 7.
I have a urinary fistula, bladder stone, or interstitial cystitis.
I have artery disease in my legs.
I frequently urinate more than usual.
I have long-term vein problems with skin changes near my ankle.
I have skin issues or infections in my lower legs.
I had surgery for stress incontinence less than a year ago.
I have a skin condition like dermatitis at the planned surgery site.
I have bladder control issues due to nerve problems.
I have vasculitis in my legs.
I am using a TENS unit for pain in my pelvic area, back, or legs.
I have had surgery or significant scarring where the implant will be placed.
I have open wounds or had surgery on my legs.
I have been diagnosed with cancer of the bladder, urethra, or prostate.
I have painful varicose veins.
I do not have severe swelling at the site of my implant.
I have severe nerve pain or numbness in my legs.
I have a weakened immune system.
Treatment Details
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.
1Treatment groups
Experimental Treatment
Group I: eCoin Tibial Nerve StimulationExperimental Treatment1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Urology Centers of AlabamaHomewood, AL
UPNT Research InstituteArlington, TX
Minnesota UrologyWoodbury, MN
Louisiana State University Health Sciences CenterShreveport, LA
More Trial Locations
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Who is running the clinical trial?
Valencia Technologies CorporationLead Sponsor
References
A novel surgical technique for implanting a new electrostimulation system for treating female overactive bladder: a preliminary report. [2019]To assess the results of peripheral electrostimulation of pelvic floor muscles in patients with overactive bladder (OAB) symptoms, and to describe a novel surgical technique for inserting a specially designed implantable electrostimulator which can deliver different forms of muscle stimulation through a para-urethral electrode.
Feasibility of a Fully Implanted, Nickel Sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence. [2019]We performed a clinical feasibility trial to evaluate the safety and efficacy of a fully implanted, primary battery powered, nickel sized and shaped neuromodulation device called the eCoin® for tibial nerve stimulation to treat refractory urgency urinary incontinence.
Pivotal Study of Leadless Tibial Nerve Stimulation with eCoin® for Urgency Urinary Incontinence: An Open-Label, Single Arm Trial. [2021]A novel leadless tibial nerve stimulator provides a primary battery-powered, coin-sized, minimally invasive option to deliver automatic low-duty cycle stimulation for overactive bladder syndrome therapy. A pivotal trial was conducted to evaluate the safety and efficacy of this investigational device, eCoin®, for treating refractory urgency urinary incontinence.
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]To evaluate the safety and efficacy of the eCoin - a nickel-sized, primary battery-powered, neuromodulation device for the treatment of urgency urinary incontinence which is implanted in the lower leg in a 20-minute procedure under local anesthesia. A feasibility clinical trial was conducted and the results after 1 year of treatment with the eCoin are presented.
Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence. [2022]The eCoin (Valencia Technologies Corporation, Valencia, CA) is a battery-powered, nickel-sized and shaped neuromodulation device for the treatment of overactive bladder, and it is implanted in the lower leg in a short office or outpatient procedure under local anesthesia. A follow-on trial was conducted to evaluate the feasibility, safety, and efficacy of eCoin reimplantation.
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]Peripheral electrical nerve stimulation is a routinely recommended treatment for non-neurogenic overactive bladder but has not been approved for patients with neurogenic lower urinary tract dysfunction (NLUTD). This systematic review and meta-analysis was to elucidate the efficacy and safety of electrostimulation and thus provide firm evidence for treating NLUTD.