A Clinical Study for Magnetic Stimulation of the Posterior Tibial Nerve in Overactive Bladder

Study Overview
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Brief Summary
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To evaluate the safety and feasibility of non-invasive magnetic stimulation of the posterior tibial nerve using the EMKinetics LoFIT Pulse System for treating patients with documented overactive bladder.

Official Title
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A Pilot Clinical Study to Evaluate the Initial Feasibility of Neuromodulation Therapy in Treating Patients With Overactive Bladder Via Magnetic Stimulation of the Posterior Tibial Nerve

Conditions
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Overactive Bladder

Intervention / Treatment
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* Device: EMKinetics non-invasive Magnetic neurostimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women >18 years of age A score of > 4 on the OAB-q short form for urgency (question 1) Average urinary frequency > 10 times in one 24 hour day based on a 3-day voiding diary Self-reported bladder symptoms present > 3 months Self-reported failed conservative care (e.g., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.) or use of antimuscarinics. Off all anti-muscarinics for at least 2 weeks prior to enrollment Capable of giving informed consent Ambulatory and able to use a toilet independently, without difficulty Capable and willing to follow all study-related procedures Exclusion Criteria: The patient is pregnant or intends to become pregnant during the course of the study. (Patients becoming pregnant during the course of the study will immediately be terminated from the study.) The patient has an active urinary tract infection. Neurogenic bladder Botox use in bladder or pelvic floor muscles in the past year Pacemakers or implantable defibrillators Primary complaint of stress urinary incontinence Current vaginal infection Current use of InterStim Current use of Bion Current use of TENS in the pelvic region, back or leg Previously been treated with PTNS Use of investigational drug/device therapy within the past 4 weeks Participating or have participated within the past 4 weeks in any clinical investigation involving or impacting gynecologic, urinary or renal function Deemed unsuitable for enrollment in study by the investigators based on subjects' history or physical examination The patient has metal implant from surgery or a metallic foreign body in either leg below (distal to) the knee (or permanent metallic tattoo <30cm from left ankle). The patient has chronic constipation (less than two (2) bowel movements per week) The patient has history of gastric or urinary retention The patient has uncontrolled diabetes Subjects with nerve damage, injury or surgery that would impact either tibial nerve or pelvic floor function The patient is unable or unwilling to sign informed consent The patient is currently on pharmacologic treatment that could affect bladder function Known Cystocele >/= to Grade 3 that has not been reduced by treatment (surgery or pessary)

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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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: EMKinetics non-invasive Magnetic neurostimulator|Patients will be treated with 12 weekly sessions of magnetic stimulation of the posterior tibial nerve at 20 hz using the EMKinetics non-invasive Magnetic neurostimulator.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Response Assessment | Improved score on the Global Response Assessment (GRA) scale after 12 weeks of therapy. A score of 2 (moderately improved) or 3 (markedly improved) constitutes a responder on the 7 point scale | After 12 weeks of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Frequency | Change in Urinary Frequency (Voiding Diary) from Baseline to 12 weeks | After 12 weeks of therapy | 
| Urinary Incontinence | Change in Urinary Incontinence (Voiding Diary) from Baseline to 12 weeks | After 12 weeks of therapy | 
| Overactive Bladder Symptoms (OAB-q SF) | Change in Overactive Bladder Symptoms (OAB-q SF) from Baseline to 12 weeks | After 12 weeks of therapy |