Foot/Hand Neuromodulation for Overactive Bladder (OAB)

Study Overview
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Brief Summary
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The purpose of this study is to determine if electrical stimulation of the foot is effective in the treatment of overactive bladder conditions.

Detailed Description
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Foot neuromodulation is designed to treat OAB conditions by electrically stimulating the somatic afferent nerves in the foot using skin surface electrodes. The foot stimulation is non-invasive, can be performed at home, and has no adverse effects. Foot neuromodulation therapy will likely be accepted by more patients and have the potential to make a broader impact on the improvement of OAB conditions.

Official Title
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Foot/Hand Neuromodulation for Overactive Bladder (OAB)

Conditions
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Overactive Bladder

Intervention / Treatment
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* Device: Foot stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 year old men and women and older Currently having overactive bladder (OAB) symptoms, i.e. urgency, frequency, or incontinence No evidence of neurological disorder or urinary tract infection, i.e. clinically diagnosed as idiopathic OAB Exclusion Criteria: Pregnant women in their late pregnancy phase will be excluded because the increasing size of the baby/uterus may cause overactive bladder. Patients with implanted electrical stimulators such as pacemaker will be excluded for potential interference with the TENS stimulator. Patients who are allergic to Cipro or Bactrim will be excluded from the CMG study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CMG group<br>Foot stimulation will be applied during a cystometrogram (CMG). | Device: Foot stimulation<br>* Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.<br>|
| Active Comparator: 3 hours group<br>Foot stimulation will be applied daily for 3 hours in the evening. | Device: Foot stimulation<br>* Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.<br>|
| Active Comparator: 1/2 hour group<br>Foot stimulation will be applied daily for 1/2 hour in the evening. | Device: Foot stimulation<br>* Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.<br>|
| Active Comparator: 3 hour hand group<br>Hand stimulation will be applied daily for 3 hours in the evening. | Device: Foot stimulation<br>* Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Urinary Incontinence Episodes Per Day | Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation), and week 3 (post foot stimulation). The average number per day urinary incontinence episodes was calculated for week 1 and week 2 for each subject. | Week 1, Week 2, Week 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Urinary Urgency Episodes Per Day | Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation), and week 3 (post foot stimulation). The average number per day urinary urgency episodes was calculated for week 1 and week 2 for each subject. | Week 1, Week 2, Week 3 |