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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 below

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I have had overactive bladder symptoms for at least 6 months.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks after device activation for reporting.

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

0 / 2Eligibility criteria met

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

Media Library

eCoin (Tibial Nerve Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03556891 — N/A

Urge Incontinence Research Study Groups: eCoin Tibial Nerve Stimulation

Urge Incontinence Clinical Trial 2023: eCoin Highlights & Side Effects. Trial Name: NCT03556891 — N/A

eCoin (Tibial Nerve Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03556891 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widespread is the implementation of this experiment?

"This experiment is recruiting participants at Chesapeake Urology in Owings Mills, Maryland, UnityPoint Clinic in Waterloo, Iowa, and The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute) in Allentown. Additionally, it has been extended to 15 other medical centres across the country."

Answered by AI

Is there a possibility for me to participate in this experiment?

"This trial requires prospective participants to be aged 18-80, and have a diagnosis of urinary incontinence. There are currently 133 patients enrolled in this project."

Answered by AI

Are there current opportunities for participants to join the trial?

"According to clinicaltrials.gov, patient recruitment for this medical experiment has concluded. Initially posted on September 4th 2018 and last edited October 11th 2022, the study no longer seeks participants; however there are 200 other trials actively recruiting at this time."

Answered by AI

Is the age requirement for participation in this study over 25 years?

"The age range for potential participants in this trial is from 18 to 80 years old. Additionally, there are 24 trials available for minors and 174 studies that focus on patients aged 65 or older."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

2018. "Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03556891.

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