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.
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT03029624
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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.
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.
All locations for NCT03029624
United States (5)
The Clark Center for Urogynecology
Newport Beach, California, United States, 92663
Waterloo, Iowa, United States, 50703
Alliance Urology Specialists
Greensboro, North Carolina, United States, 27403
The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)
Allentown, Pennsylvania, United States, 18103
Urology Center of Englewood
Englewood, New Jersey, United States, 07631
New Zealand (3)
Christchurch, New Zealand, 8013
Roundhay Medical Centre
Nelson, New Zealand
Tauranga Urology Research Ltd
Tauranga, New Zealand
View full eligibility
Tris trial is registered with FDA with number: NCT03029624. The sponsor of the trial is Valencia Technologies Corporation and it is looking for 46 volunteers for the current phase.
Official trial title: Subcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence
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