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

Primary Purpose

Overactive Bladder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Foot stimulation
Sponsored by
Christopher J Chermansky, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

CMG group

3 hours group

1/2 hour group

3 hour hand group

Arm Description

Foot stimulation will be applied during a cystometrogram (CMG).

Foot stimulation will be applied daily for 3 hours in the evening.

Foot stimulation will be applied daily for 1/2 hour in the evening.

Hand stimulation will be applied daily for 3 hours in the evening.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 18, 2013
Last Updated
February 14, 2020
Sponsor
Christopher J Chermansky, MD
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1. Study Identification

Unique Protocol Identification Number
NCT01972061
Brief Title
Foot/Hand Neuromodulation for Overactive Bladder (OAB)
Acronym
FootStim
Official Title
Foot/Hand Neuromodulation for Overactive Bladder (OAB)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Lack of continued funding
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 11, 2018 (Actual)
Study Completion Date
December 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christopher J Chermansky, MD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CMG group
Arm Type
Experimental
Arm Description
Foot stimulation will be applied during a cystometrogram (CMG).
Arm Title
3 hours group
Arm Type
Active Comparator
Arm Description
Foot stimulation will be applied daily for 3 hours in the evening.
Arm Title
1/2 hour group
Arm Type
Active Comparator
Arm Description
Foot stimulation will be applied daily for 1/2 hour in the evening.
Arm Title
3 hour hand group
Arm Type
Active Comparator
Arm Description
Hand stimulation will be applied daily for 3 hours in the evening.
Intervention Type
Device
Intervention Name(s)
Foot stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Urinary Incontinence Episodes Per Day
Description
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 Outcome Measure Information:
Title
Number of Urinary Urgency Episodes Per Day
Description
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
Other Pre-specified Outcome Measures:
Title
Bladder Volume as Recorded on CMG for Strong Desire to Void
Description
Subject reports to the clinic for two CMGs. CMG #1 is the baseline measurement. CMG #2 is recorded during Foot Stimulation
Time Frame
CMG #1 and CMG#2
Title
Number of Urinary Voids Per Day
Description
Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation) and week 3 (post foot stimulation)
Time Frame
Week 1, Week 2, Week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Chermansky, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dawn McBride, RN
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Director
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Foot/Hand Neuromodulation for Overactive Bladder (OAB)

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