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

Inclusion criteria

• Female subjects between the ages of 18 to 80 years old diagnosed with idiopathic OAB.
• Subject has signed Informed Consent Form and is willing and able to comply with all requirements of the protocol.
• Subjects with symptoms of incontinence associated with OAB for ≥ 3 months prior to screening.
• Subjects who are non-responsive, non-compliant or intolerable to pharmacologic oral therapy (e.g., anticholinergic agents).
• Subject is willing and able to initiate self-catheterization post-treatment, if required.
• Subjects with PVR ≤200 ml.
• Subjects who are mentally competent, with the ability to understand and comply with the requirements of the study.
• A negative urine pregnancy test during screening in women with childbearing potential. A female subject will also agree to use an adequate birth control method for the duration of her participation in the study and for a period of 6 months after participation completion.

Exclusion criteria

• Subjects currently using Clean intermittent catheterization (CIC) or indwelling catheter to manage their urinary incontinence.
• 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.
• Subjects with clinically significant Bladder Outlet Obstruction (BOO) according to medical history.
• Subjects with active urinary tract infection, as diagnosed on screening urinalysis.
• Subjects with known polyuria or polydipsia.
• Subjects with a known positive diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.
• Subjects with OAB due to any known neurological reason.
• 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.
• Subject with a 24-hour total urine volume voided greater than 3,000 ml, as measured at screening visit.
• Predominance of stress incontinence in the opinion of the investigator, determined by medical history.
• Subjects with vesico-ureteral reflux, genitourinary fistulae.
• 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).
• Subjects with prior Botox™ therapy of any serotype within 12 weeks for any indication, including urologic condition.
• Subjects with a history of pelvic radiation therapy.
• Subject who is morbidly obese (BMI > 40 Kg/m2).
• 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.
• Subjects on immunomodulatory therapy (suppressive or stimulatory).
• 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.
• Subjects with operative sling erosion.
• History of interstitial cystitis/painful bladder syndrome, in the opinion of the investigator.
• 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).
• Subject has severe cardiac, pulmonary, renal, or hepatic disease that in the judgment of the study physician would preclude participation in this study.
• Any other condition or medical history, that to the discretion of the investigator and/or Sponsor, excludes the subject from participation in the study.