eCoin Tibial Nerve Stimulation for OAB

Urgency Urinary Incontinence Clinical Trial

Official title:

Subcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03029624
• Other study ID #: 111-3175
• Status: Completed
• Phase: N/A
• Start date: April 3, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: November 2020
• Source: Valencia Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 1, 2018
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Urgency Urinary Incontinence
• Urinary Incontinence

Intervention

Device:
• eCoin
Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy.

Locations

Country	Name	City	State
New Zealand	Urology Associates	Christchurch
New Zealand	Roundhay Medical Centre	Nelson
New Zealand	Tauranga Urology Research Ltd	Tauranga
United States	The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)	Allentown	Pennsylvania
United States	Alliance Urology Specialists	Greensboro	North Carolina
United States	The Clark Center for Urogynecology	Newport Beach	California
United States	UnityPoint Clinic	Waterloo	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Valencia Technologies Corporation

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incontinent Episodes	The change in number of incontinence episodes from baseline to three months post-activation.	Baseline to three months post-activation.
Secondary	System and Procedure Related AEs	Number of System and Procedure Related Adverse Events from implantation to one month post-implantation.	Implantation to one month post-implantation.
Secondary	MAEs	Number of all Major Adverse Events from baseline to 3 months post-activation.	Baseline to 3 months post-activation.
Secondary	Percentage of Responders	Percentage of Responders, defined as participants who experienced a 50% or greater reduction in UUI after 3 months of treatment	3 months after activation