Open Label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous URIS I in the Treatment of Overactive Bladder (OAB).

Study Overview
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Brief Summary
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Open label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder.

Detailed Description
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Open label, Multi center Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder (OAB).

Official Title
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Open Label, Multi Center Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I (Tesla Medical) in the Treatment of Overactive Bladder (OAB).

Conditions
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Overactive Bladder (OAB), Failed Any OAB Pharmacotherapy

Intervention / Treatment
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* Device: eTNM delivered by URIS I nerve stimulation device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18 years or older, inclusive Diagnosis of OAB or mixed incontinence with the predominance of OAB symptoms Dissatisfaction with any current or previous pharmacotherapy treatment of OAB for any reason within the past 12 months Treatment Satisfaction VAS <50 Ability to understand and sign ICF Subject agreed to attend all follow up evaluations and was willing to completely and accurately fill out voiding diaries and questionnaires, and was willing to complete required exams and tests Subject agreed not to participate in another research study from the time of screening until the final study visit Subject agreed not to use a pharmacotherapy treatment for OAB from the time of screening until the final study visit Exclusion Criteria: Prior treatment with botulotoxin for OAB Previous pharmacotherapy for OAB if >12 months ago Urinary retention with post void residual > 150ml Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury and nerves of lower limbs History or presence of stress incontinence, or mixed incontinence where stress incontinence was predominant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| eTNM arm<br>eTNM delivered by URIS I nerve stimulation device, self administered in the subject's home for 30 minutes per day, for a minimum of 34 therapy session between day 1- 42. | Device: eTNM delivered by URIS I nerve stimulation device<br>* eTNM delivered by URIS I nerve stimulation device, self administered in the subject's home for 30 minutes per day, for a minimum of 34 therapy session between day 1-42.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of severe urgency episodes | The proportion of subjects with ≥ 50% change in severe urgency episodes (Grade 3 or 4) will be summarized by visit and for the full treatment period using the last observation. | baseline and end of study (6weeks treatment) |