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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24, 36, 48, and 60 months
Awards & highlights
RECIPE Trial Summary
This trial tests a device to reduce overactive bladder & urgency urinary incontinence episodes in 12 months, using diaries & patient reported-outcomes.
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.Check my eligibility
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.See study design
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.
RECIPE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
RECIPE Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety
Secondary outcome measures
Responder Rate
Safety Data
Safety data through 7 months post-reimplantation.
Other outcome measures
Device-related adverse events from implantation.
Patient reported overactive bladder condition improvement.
Patient reported qualify of life
+11 moreRECIPE 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
2019
N/A
~30
Find a Location
Who is running the clinical trial?
Valencia Technologies CorporationLead Sponsor
5 Previous Clinical Trials
252 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a lot of leftover urine in your bladder after going to the bathroom.I currently have a urinary tract infection.I have severe bladder pain or have been diagnosed with interstitial cystitis.You mostly leak urine when you cough, sneeze, or exercise.I have artery disease in my legs.I have a significant blockage in my bladder outlet.I frequently urinate more than usual.I have a serious narrowing of my urethra or bladder neck.I have long-term vein problems with skin changes near my ankle.I have skin issues or infections in my lower legs.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.I am over 18 and my participation reflects the gender distribution of this disease.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 had surgery for stress incontinence less than a year ago.My diabetes is not under control, with an A1C level over 7.I have a urinary fistula, bladder stone, or interstitial cystitis.I understand all the study requirements and can make decisions.I have received PTNS treatment recently or its effects are still present.I do not have bladder stones or cancer, confirmed by tests.I have been treated with Botox in the last 9 months or longer if still effective.I have a bleeding disorder or am on blood thinners and may not be suitable for the study.I have been diagnosed with cancer of the bladder, urethra, or prostate.My doctor says I am fit for surgery.I have been diagnosed with an overactive bladder that causes sudden urges to urinate.I have painful varicose veins.I do not have severe swelling at the site of my implant.I haven't taken medication for overactive bladder for at least 2 weeks.I have severe nerve pain or numbness in my legs.I have a weakened immune system.
Research Study Groups:
This trial has the following groups:- Group 1: eCoin Tibial Nerve Stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this investigation offer opportunities for individuals to partake?
"As indicated on clinicaltrials.gov, this medical trial is no longer in search of participants. Although the study was first publicized on January 1st 2023 and had its most recent update a month later, 193 other trials are actively recruiting patients at present."
Answered by AI
Who else is applying?
What site did they apply to?
University of California, Irvine
What portion of applicants met pre-screening criteria?
Met criteria
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