BlueWind Medical System for the Treatment of Patients With OAB

BlueWind Medical system safety and performance in treatment of patients diagnosed with overactive bladder (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.