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Tibial Nerve Stimulation
eCoin for Overactive Bladder
N/A
Waitlist Available
Led By Scott MacDiarmid, MD
Research Sponsored by Valencia Technologies Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and stress incontinence with a predominant urgency component (self-reported), for at least 6 months
Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks after device activation
Awards & highlights
Study Summary
This trialstudies the safety & effectiveness of a nerve stimulator for treating OAB/UUI symptoms. It evaluates changes from baseline in OAB symptoms for up to 48/52 weeks.
Who is the study for?
This trial is for men and women aged 18-80 with overactive bladder (OAB) and urgency urinary incontinence who haven't had success with standard treatments like anticholinergics or Botox. Participants should not be on OAB medication currently and must have been dealing with symptoms for at least six months.Check my eligibility
What is being tested?
The eCoin Tibial Nerve Stimulation device is being tested to see if it can help control the symptoms of an overactive bladder. This single-arm study will track changes in participants' bladder activity through diaries and questionnaires for up to one year after implantation.See study design
What are the potential side effects?
Potential side effects may include discomfort at the implant site, skin irritation or infection, inflammation, allergic reactions to the device materials, or unintended impacts on bladder function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had overactive bladder symptoms for at least 6 months.
Select...
I am not taking medication for overactive bladder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks after device activation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks after device activation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Secondary outcome measures
Moderate-term Effectiveness Data. Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Moderate-term Safety in All Patients. Percentage of Patients With Device or Implantation Related Adverse Events.
Trial Design
1Treatment groups
Experimental Treatment
Group I: eCoin Tibial Nerve StimulationExperimental Treatment1 Intervention
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
319 Total Patients Enrolled
Scott MacDiarmid, MDPrincipal InvestigatorAlliance Urology
2 Previous Clinical Trials
176 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I've tried specific bladder treatments without success or couldn't tolerate them.Most of my urinary leaks happen when I cough, sneeze, or exercise.I have healthy skin on both of my lower legs without signs of infection or inflammation.I am between 18 and 80 years old.I have had overactive bladder symptoms for at least 6 months.I am not taking medication for overactive bladder.I have a significant blockage in my bladder.My pelvic organs have dropped below the vaginal opening.
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.
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