Foot/Hand Neuromodulation for Overactive Bladder (OAB)

Christopher J Chermansky, MD1 site in 1 country44 target enrollmentMarch 2014

ConditionsOveractive Bladder

Overview

Phase: N/A
Intervention: Not specified
Conditions: Overactive Bladder
Sponsor: Christopher J Chermansky, MD
Enrollment: 44
Locations: 1
Primary Endpoint: Number of Urinary Incontinence Episodes Per Day
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

December 11, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Christopher J Chermansky, MD

Responsible Party

Sponsor Investigator

Principal Investigator

Christopher J Chermansky, MD

Assistant Professor of Urology

University of Pittsburgh

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Number of Urinary Incontinence Episodes Per Day

Time Frame: Week 1, Week 2, Week 3

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.