BlueWind Medical System for the Treatment of Patients With OAB

Study Overview
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Brief Summary
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BlueWind system safety and performance in treatment of patients diagnosed with overactive bladder (OAB)

Detailed Description
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BlueWind Medical system safety and performance in treatment of patients diagnosed with overactive bladder (OAB)

Official Title
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Safety and Performance of the BlueWind System for the Treatment of Patients With Overactive Bladder (OAB) Amended to Allow Extended Follow up of the Patients

Conditions
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Over Active Bladder

Intervention / Treatment
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* Device: BlueWind Medical system


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OAB<br>Patients with overactive bladder (OAB) with or without urge incontinence. Two patient populations will be enrolled in the study: Patients with no previous treatment with percutaneous tibial nerve stimulation (PTNS) [de novo patient group] and Patients with a documented success on PTNS therapy [prior-PTNS group]. Documented success on PTNS is defined by a ≥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. All patients will be treated with BlueWind Medical System. | Device: BlueWind Medical system<br>* The BlueWind Medical System is intended for the treatment of patients with overactive bladder (OAB) including urinary urgency frequency and urge incontinence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse events | Incidence of serious adverse events system and or procedure related | 6 months | 
| Incidence of serious adverse events (amended) | Incidence of serious adverse events system and or procedure related (amended) | 36 months |