Study Stopped
Lack of continued funding
Foot/Hand Neuromodulation for Overactive Bladder (OAB)
FootStim
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2013
CompletedFirst Posted
Study publicly available on registry
October 30, 2013
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2018
CompletedResults Posted
Study results publicly available
February 26, 2020
CompletedFebruary 26, 2020
February 1, 2020
4.8 years
October 18, 2013
November 26, 2019
February 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of Urinary Urgency Episodes Per Day
Week 1, Week 2, Week 3
Other Outcomes (2)
Bladder Volume as Recorded on CMG for Strong Desire to Void
CMG #1 and CMG#2
Number of Urinary Voids Per Day
Week 1, Week 2, Week 3
Study Arms (4)
CMG group
EXPERIMENTALFoot stimulation will be applied during a cystometrogram (CMG).
3 hours group
ACTIVE COMPARATORFoot stimulation will be applied daily for 3 hours in the evening.
1/2 hour group
ACTIVE COMPARATORFoot stimulation will be applied daily for 1/2 hour in the evening.
3 hour hand group
ACTIVE COMPARATORHand stimulation will be applied daily for 3 hours in the evening.
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The 3 hour hand group was not started or completed due to lack of funding.
Results Point of Contact
- Title
- Dr. Christopher Chermansky
- Organization
- University of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Chermansky, MD
University of Pittsburgh
- STUDY DIRECTOR
Dawn McBride, RN
University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor of Urology
Study Record Dates
First Submitted
October 18, 2013
First Posted
October 30, 2013
Study Start
March 1, 2014
Primary Completion
December 11, 2018
Study Completion
December 11, 2018
Last Updated
February 26, 2020
Results First Posted
February 26, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share