eCoin Tibial Nerve Stimulation for OAB

November 30, 2020 updated by: Valencia Technologies Corporation

Subcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence

The study is a single arm, prospective study of the safety and effectiveness of the Valencia Technologies eCoin System to stimulate the tibial nerve for the treatment of patients with refractory urgency urinary incontinence.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This trial is a single arm, prospective study of the safety and effectiveness of eCoin tibial nerve stimulation in 25 subjects with refractory overactive bladder as defined by the American Urological Association.. The eCoin neuromodulation device will be implanted subcutaneously in the right or left leg of patients with urgency urinary incontinence. After a 4 week implant healing period, subjects will have their devices activated (turned ON). After 3 months of device therapy (occurring 4 months post-implant), the primary endpoint will be assessed. It is anticipated that subjects will reach the full therapeutic effect at approximately 3 months of therapy. Subjects will be followed for an additional 9 months to assess the safety of maintenance stimulation therapy with fewer sessions occurring during this time interval.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Women and men 18 years and older.
  2. Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and stress incontinence with a predominant urgency component, for at least 6 months (self-reported).
  3. Individual has at least four urgency incontinence episodes on a three-day voiding diary with at least one episode per 24 hour time period
  4. Individual with urinary frequency, defined as an average of greater than or equal to 8 times/24 hours (ie. a total of greater than or equal to 24 micturitions on a 3 day diary)
  5. Individual is unresponsive to, inadequately responsive to, or intolerant of behavioral, rehabilitation, and pharmacologic therapy.
  6. Individual is able to give his or her written, informed consent.
  7. Individual is mentally competent and able to understand all study requirements.
  8. Individual is willing and able to complete a 3-day voiding diary and quality of life questionnaire.
  9. Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists) for 2 weeks prior to screening.
  10. The individual demonstrates a positive nerve integrity test.

Exclusion Criteria:

  1. Individual has predominantly stress urinary incontinence
  2. Individual has clinically significant bladder outlet obstruction.
  3. Individual has clinically significant pelvic organ prolapse.
  4. Individual has abnormal post void residual (i.e., greater than 150 cc).
  5. Individual has clinically significant urethral stricture disease or bladder neck contracture
  6. Individual has an active urinary tract infection at time of enrollment.
  7. Individual has recurrent urinary tract infections defined as 4 or more UTI's per year.
  8. Individual has morbid obesity.
  9. Individual has had positive urine cytology or diagnosis of bladder or prostate cancer.
  10. Individual has neurogenic bladder dysfunction.
  11. Individual is taking an alpha-blocker for benign prostatic hyperplasia.
  12. Individual is pregnant or intends to become pregnant during the study.
  13. Patient is breast feeding or is less than 9-month post-partum.
  14. Individual has the presence of urinary fistula, bladder stone, or interstitial cystitis.
  15. Individual has uncontrolled diabetes mellitus.
  16. Individual has a cardiac pacemaker or implanted defibrillator.
  17. Individual has been previously treated with sacral nerve stimulation.
  18. Individual has been treated with onabotulinumtoxinA in the previous 9 months prior to enrollment.
  19. Individual has been treated with percutaneous tibial nerve stimulation within the previous 12 weeks prior to enrollment.
  20. Individual requires regular Magnetic Resonance Imaging for other health care conditions. (ASK)
  21. Individual has a clotting or bleeding disorder; antiplatelet and anticoagulant therapy may be continued or held at the discretion of the investigator
  22. Individual has a clinically significant peripheral neuropathy.
  23. Individual is neutropenic or immunocompromised.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Arm
Treatment Arm receives implanted eCoin device and therapy is turned ON.
Device: eCoin
Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incontinent Episodes
Time Frame: Baseline to three months post-activation.
The change in number of incontinence episodes from baseline to three months post-activation.
Baseline to three months post-activation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
System and Procedure Related AEs
Time Frame: Implantation to one month post-implantation.
Number of System and Procedure Related Adverse Events from implantation to one month post-implantation.
Implantation to one month post-implantation.
MAEs
Time Frame: Baseline to 3 months post-activation.
Number of all Major Adverse Events from baseline to 3 months post-activation.
Baseline to 3 months post-activation.
Percentage of Responders
Time Frame: 3 months after activation
Percentage of Responders, defined as participants who experienced a 50% or greater reduction in UUI after 3 months of treatment
3 months after activation

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Valencia Technologies Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sharon English, MD, Urology Associates
  • Principal Investigator: Scott MacDiarmid, MD, Alliance Urology Specialists

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 111-3175

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

product manufactured in and exported from the U.S.

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.

Clinical Trials on Urgency Urinary Incontinence

Clinical Trials on eCoin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings