Foot/Hand Neuromodulation for Overactive Bladder (OAB)

N/ATerminatedNCT01972061

Christopher J Chermansky, MD44 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Overactive Bladder

Interventions

Foot stimulationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 18 year old men and women and older 2. Currently having overactive bladder (OAB) symptoms, i.e. urgency, frequency, or incontinence 3. No evidence of neurological disorder or urinary tract infection, i.e. clinically diagnosed as idiopathic OAB Exclusion Criteria: 1. Pregnant women in their late pregnancy phase will be excluded because the increasing size of the baby/uterus may cause overactive bladder. 2. Patients with implanted electrical stimulators such as pacemaker will be excluded for potential interference with the TENS stimulator. 3. Patients who are allergic to Cipro or Bactrim will be excluded from the CMG study.

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: Week 1, Week 2, Week 3

Secondary Outcomes

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.

Time frame: Week 1, Week 2, Week 3

Data from ClinicalTrials.gov

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