eCoin Tibial Nerve Stimulation for Urinary Incontinence

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Urinary Incontinence+6 More
eCoin Tibial Nerve Stimulation - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a device can help people with overactive bladder.

Eligible Conditions
  • Urinary Incontinence
  • Overactive Bladder Syndrome (OABS)
  • Urinary Urge Incontinence

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 24 weeks after device activation

Week 24
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.
Week 48
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
52 weeks after implantation.
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.

Trial Safety

Trial Design

1 Treatment Group

eCoin Tibial Nerve Stimulation
1 of 1
Experimental Treatment

133 Total Participants · 1 Treatment Group

Primary Treatment: eCoin Tibial Nerve Stimulation · No Placebo Group · N/A

eCoin Tibial Nerve Stimulation
Device
Experimental Group · 1 Intervention: eCoin Tibial Nerve Stimulation · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
eCoin Tibial Nerve Stimulation
2019
N/A
~30

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks after device activation

Who is running the clinical trial?

Valencia Technologies CorporationLead Sponsor
3 Previous Clinical Trials
69 Total Patients Enrolled
2 Trials studying Urinary Incontinence
69 Patients Enrolled for Urinary Incontinence
Scott MacDiarmid, MDPrincipal InvestigatorAlliance Urology
2 Previous Clinical Trials
176 Total Patients Enrolled
2 Trials studying Urinary Incontinence
176 Patients Enrolled for Urinary Incontinence

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: October 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.