Foot/Hand Neuromodulation for Overactive Bladder (OAB) (FootStim)

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

Study Overview

• Status: Terminated
• Conditions: Overactive Bladder
• Intervention / Treatment: Device: Foot stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CMG group; Foot stimulation will be applied during a cystometrogram (CMG).	Device: Foot stimulation; 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.
Active Comparator: 3 hours group; Foot stimulation will be applied daily for 3 hours in the evening.	Device: Foot stimulation; 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.
Active Comparator: 1/2 hour group; Foot stimulation will be applied daily for 1/2 hour in the evening.	Device: Foot stimulation; 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.
Active Comparator: 3 hour hand group; Hand stimulation will be applied daily for 3 hours in the evening.	Device: Foot stimulation; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bladder Volume as Recorded on CMG for Strong Desire to Void	Subject reports to the clinic for two CMGs. CMG #1 is the baseline measurement. CMG #2 is recorded during Foot Stimulation	CMG #1 and CMG#2
Number of Urinary Voids Per Day	Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation) and week 3 (post foot stimulation)	Week 1, Week 2, Week 3

Collaborators and Investigators

• Sponsor: Christopher J Chermansky, MD
• Investigators: Principal Investigator: Christopher Chermansky, MD, University of Pittsburgh; Study Director: Dawn McBride, RN, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): December 11, 2018
• Study Completion (Actual): December 11, 2018

Study Registration Dates

• First Submitted: October 18, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (Estimate): October 30, 2013

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 14, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: PRO13020474

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO