BlueWind Medical System for the Treatment of Patients With OAB

Inclusion Criteria: * Signed written informed consent. * Male or female aged 18 - 80. * Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out voiding diaries and questionnaires, and is willing to complete required exams and tests. * Patients with overactive bladder symptoms: * Urinary frequency greater than 8 times/24 hours AND/OR Urinary urgency leaks of at least 2 leaks on 3 day voiding diary * Patient who has failed conservative treatment after at least 6 months of treatment * Patients with normally functioning upper urinary tract. * Patients with no clinical evidence of a neurological S2-S4 motor sensory deficit. * Prior PTNS Group: Patients who have had successful PTNS treatment (successful treatment is defined as ≥50% reduction in urinary frequency, and/or ≥50% fewer incontinence episodes, or a return to normal voiding frequency \[\<8 voids/day\], based on retrospective diary review). * De novo Patient Group: Patient who passes the BlueWind compatibility test. Exclusion Criteria: * Any metal implant in the area of BlueWind Medical implantation site. * Patients who have not had stable OAB medications for at least 30 days. * Patients who have received botulinum toxin injections within the past 6 months. * Previous urinary incontinence surgery or implantation of artificial graft material within the last 6 months. * Any spinal or genitourinary surgery within the last 6 months. Pelvic pain disorders * Obvious clinically demonstrated genuine stress incontinence. * Any neurological disease or disorder including neuropathy or injury resulting in neuropathy. * Current urinary tract infection, presence of urinary stone and/or urinary tract malignancy (i.e. tumor, vesicourethral reflux, etc.) * Pelvic radiotherapy and chemotherapy. * Severe uncontrolled diabetes. * Patients anticipating magnetic resonance imaging (MRI) exams. * Presence of cystocele, enterocele or rectocele of grade 3 or 4. * Prior PTNS Group: Patients who are receiving concomitant nerve stimulation therapies for OAB treatment, except for PTNS maintenance therapy. * De novo Patient Group: Patients who have received or are receiving nerve stimulation therapies for OAB treatment, including PTNS.