eCoin for OAB Feasibility Follow-on Study

October 11, 2022 updated by: Valencia Technologies Corporation

SUBCUTANEOUS TIBIAL NERVE STIMULATION FOR URGENCY URINARY INCONTINENCE: A FOLLOW-ON STUDY

This trial is a prospective, multicenter, single-arm follow-on study will evaluate the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects with urgency urinary incontinence (UUI) as defined by the American Urological Association (30). The follow-on study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient-reported outcomes through 24 weeks of eCoinTM therapy (which is the same as 28 weeks from study device reimplantation).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Christchurch, New Zealand, 8013
        • Urology Associates
      • Nelson, New Zealand
        • Roundhay Medical Centre
      • Tauranga, New Zealand
        • Tauranga Urology Research Ltd
  • United States
    • California
      • Newport Beach, California, United States, 92663
        • The Clark Center for Urogynecology
    • Iowa
      • Waterloo, Iowa, United States, 50703
        • UnityPoint Clinic
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • Alliance Urology Specialists
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Individual participated in the eCoin Feasibility Study for Urgency Urinary Incontinence.
  2. Individual was implanted with the study device during the eCoin Feasibility Study for Urgency Urinary Incontinence.

Exclusion Criteria:

1. In the opinion of the investigator, individual is not a good candidate for participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: eCoin Tibial Nerve Stimulation
Device: eCoin Tibial Nerve Stimulation
Subcutaneous stimulation of the tibial nerve using the eCoin device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Time Frame: 12 weeks after device activation.
12 weeks after device activation.
Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 4 Months After Implantation.
Time Frame: 16 weeks after device implantation.
Instances of a related adverse event.
16 weeks after device implantation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Time Frame: 24 weeks after device activation.
24 weeks after device activation.
Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation.
Time Frame: 28 weeks after device implantation.
Instances of a related adverse event
28 weeks after device implantation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valencia Technologies Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2019

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

September 12, 2022

Study Registration Dates

First Submitted

August 29, 2018

First Submitted That Met QC Criteria

August 29, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

October 17, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111-3335

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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