Clinical trial NCT03029624: eCoin Tibial Nerve Stimulation for OAB
Official title: Subcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urgency Urinary Incontinence
Lead sponsor: Valencia Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2017-01-24
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incontinent Episodes
timeFrame: Baseline to three months post-activation.
Secondary outcomes:
measure: System and Procedure Related AEs
timeFrame: Implantation to one month post-implantation.
measure: MAEs
timeFrame: Baseline to 3 months post-activation.
measure: Percentage of Responders
timeFrame: 3 months after activation
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: The Clark Center for Urogynecology
state: California
city: Waterloo
country: United States
facility: UnityPoint Clinic
state: Iowa
city: Greensboro
country: United States
facility: Alliance Urology Specialists
state: North Carolina
city: Allentown
country: United States
facility: The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)
state: Pennsylvania
city: Christchurch
country: New Zealand
facility: Urology Associates
city: Nelson
country: New Zealand
facility: Roundhay Medical Centre
city: Tauranga
country: New Zealand
facility: Tauranga Urology Research Ltd
Study officials:
affiliation: Urology Associates
name: Sharon English, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alliance Urology Specialists
name: Scott MacDiarmid, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.