eCoin Tibial Nerve Stimulation for OAB

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.