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eCoin Tibial Nerve Stimulation for OAB

Primary Purpose

Urgency Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
eCoin
Sponsored by
Valencia Technologies Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urgency Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Clark Center for Urogynecology
  • UnityPoint Clinic
  • Alliance Urology Specialists
  • The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)
  • Urology Associates
  • Roundhay Medical Centre
  • Tauranga Urology Research Ltd

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

Treatment Arm receives implanted eCoin device and therapy is turned ON.

Outcomes

Primary Outcome Measures

Incontinent Episodes
The change in number of incontinence episodes from baseline to three months post-activation.

Secondary Outcome Measures

System and Procedure Related AEs
Number of System and Procedure Related Adverse Events from implantation to one month post-implantation.
MAEs
Number of all Major Adverse Events from baseline to 3 months post-activation.
Percentage of Responders
Percentage of Responders, defined as participants who experienced a 50% or greater reduction in UUI after 3 months of treatment

Full Information

First Posted
January 20, 2017
Last Updated
November 30, 2020
Sponsor
Valencia Technologies Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03029624
Brief Title
eCoin Tibial Nerve Stimulation for OAB
Official Title
Subcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valencia Technologies Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urgency Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Treatment Arm receives implanted eCoin device and therapy is turned ON.
Intervention Type
Device
Intervention Name(s)
eCoin
Intervention Description
Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy.
Primary Outcome Measure Information:
Title
Incontinent Episodes
Description
The change in number of incontinence episodes from baseline to three months post-activation.
Time Frame
Baseline to three months post-activation.
Secondary Outcome Measure Information:
Title
System and Procedure Related AEs
Description
Number of System and Procedure Related Adverse Events from implantation to one month post-implantation.
Time Frame
Implantation to one month post-implantation.
Title
MAEs
Description
Number of all Major Adverse Events from baseline to 3 months post-activation.
Time Frame
Baseline to 3 months post-activation.
Title
Percentage of Responders
Description
Percentage of Responders, defined as participants who experienced a 50% or greater reduction in UUI after 3 months of treatment
Time Frame
3 months after activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women and men 18 years and older. 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). Individual has at least four urgency incontinence episodes on a three-day voiding diary with at least one episode per 24 hour time period 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) Individual is unresponsive to, inadequately responsive to, or intolerant of behavioral, rehabilitation, and pharmacologic therapy. Individual is able to give his or her written, informed consent. Individual is mentally competent and able to understand all study requirements. Individual is willing and able to complete a 3-day voiding diary and quality of life questionnaire. Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists) for 2 weeks prior to screening. The individual demonstrates a positive nerve integrity test. Exclusion Criteria: Individual has predominantly stress urinary incontinence Individual has clinically significant bladder outlet obstruction. Individual has clinically significant pelvic organ prolapse. Individual has abnormal post void residual (i.e., greater than 150 cc). Individual has clinically significant urethral stricture disease or bladder neck contracture Individual has an active urinary tract infection at time of enrollment. Individual has recurrent urinary tract infections defined as 4 or more UTI's per year. Individual has morbid obesity. Individual has had positive urine cytology or diagnosis of bladder or prostate cancer. Individual has neurogenic bladder dysfunction. Individual is taking an alpha-blocker for benign prostatic hyperplasia. Individual is pregnant or intends to become pregnant during the study. Patient is breast feeding or is less than 9-month post-partum. Individual has the presence of urinary fistula, bladder stone, or interstitial cystitis. Individual has uncontrolled diabetes mellitus. Individual has a cardiac pacemaker or implanted defibrillator. Individual has been previously treated with sacral nerve stimulation. Individual has been treated with onabotulinumtoxinA in the previous 9 months prior to enrollment. Individual has been treated with percutaneous tibial nerve stimulation within the previous 12 weeks prior to enrollment. Individual requires regular Magnetic Resonance Imaging for other health care conditions. (ASK) Individual has a clotting or bleeding disorder; antiplatelet and anticoagulant therapy may be continued or held at the discretion of the investigator Individual has a clinically significant peripheral neuropathy. Individual is neutropenic or immunocompromised.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon English, MD
Organizational Affiliation
Urology Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott MacDiarmid, MD
Organizational Affiliation
Alliance Urology Specialists
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Clark Center for Urogynecology
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
UnityPoint Clinic
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50703
Country
United States
Facility Name
Alliance Urology Specialists
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Urology Associates
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
Facility Name
Roundhay Medical Centre
City
Nelson
Country
New Zealand
Facility Name
Tauranga Urology Research Ltd
City
Tauranga
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35536667
Citation
Kaaki B, English S, Gilling P, Meffan P, Lucente V, MacDiarmid S, Clark M, Sen SK. Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2022 May 1;28(5):287-292. doi: 10.1097/SPV.0000000000001105. Epub 2022 Sep 22.
Results Reference
derived

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eCoin Tibial Nerve Stimulation for OAB

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