Vibe First In Human Study for the Assessment of Safety and Initial Performance of the Vibe Delivery System in Subjects With Idiopathic Overactive Bladder

Exclusion Criteria

• •1. Subjects currently using Clean intermittent catheterization (CIC) or indwelling catheter to manage their urinary incontinence.
• •2. Pregnant or breastfeeding women, or women of childbearing potential who are planning to become pregnant during the study period or not practicing reliable contraception methods.
• •3. Subjects with clinically significant Bladder Outlet Obstruction (BOO) according to medical history.
• •4. Subjects with active urinary tract infection, as diagnosed on screening urinalysis.
• •5. Subjects with known polyuria or polydipsia.
• •6. Subjects with a known positive diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.
• •7. Subjects with OAB due to any known neurological reason.
• •8. Subjects currently undergoing biofeedback, pelvic muscle rehabilitation, pelvic floor physical therapy, or electrical-stimulation who are unwilling to discontinue such treatments for the duration of study participation.
• •9. Subject with a 24-hour total urine volume voided greater than 3,000 ml, as measured at screening visit.
• •10. Predominance of stress incontinence in the opinion of the investigator, determined by medical history.
• •11. Subjects with vesico-ureteral reflux, genitourinary fistulae.
• •12. Subjects with pelvic organ prolapse stage III or IV, (i.e. the most distal part of the prolapse protruding more than 1 cm beyond the hymen at straining).
• •13. Subjects with prior Botox™ therapy of any serotype within 12 weeks for any indication, including urologic condition.
• •14. Subjects with a history of pelvic radiation therapy.
• •15. Subject who is morbidly obese (BMI \> 40 Kg/m2).
• •16. Subjects with a history of treatment for two or more UTIs within 6 months prior to screening or use of prophylactic antibiotics to prevent chronic UTIs.
• •17. Subjects on immunomodulatory therapy (suppressive or stimulatory).
• •18. History or evidence of any pelvic or lower tract genitourinary abnormalities, malignancy, bladder surgery (excluding stress incontinence or pelvic organ prolapse surgeries), or disease, other than OAB.
• •19. Subjects with operative sling erosion.
• •20. History of interstitial cystitis/painful bladder syndrome, in the opinion of the investigator.
• •21. Subjects with current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc).
• •22. Subject has severe cardiac, pulmonary, renal, or hepatic disease that in the judgment of the study physician would preclude participation in this study.
• •23. Any other condition or medical history, that to the discretion of the investigator and/or Sponsor, excludes the subject from participation in the study.