Subcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Urgency Urinary Incontinence
- Sponsor
- Valencia Technologies Corporation
- Enrollment
- 46
- Locations
- 7
- Primary Endpoint
- Incontinent Episodes
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Incontinent Episodes
Time Frame: Baseline to three months post-activation.
The change in number of incontinence episodes from baseline to three months post-activation.
Secondary Outcomes
- MAEs(Baseline to 3 months post-activation.)
- System and Procedure Related AEs(Implantation to one month post-implantation.)
- Percentage of Responders(3 months after activation)