Study Results
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View full resultsBasic Information
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TERMINATED
NA
44 participants
INTERVENTIONAL
2014-03-31
2018-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CMG group
Foot stimulation will be applied during a cystometrogram (CMG).
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.
3 hours group
Foot stimulation will be applied daily for 3 hours in the evening.
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.
1/2 hour group
Foot stimulation will be applied daily for 1/2 hour in the evening.
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.
3 hour hand group
Hand stimulation will be applied daily for 3 hours in the evening.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Christopher J Chermansky, MD
OTHER
Responsible Party
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Christopher J Chermansky, MD
Assistant Professor of Urology
Principal Investigators
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Christopher Chermansky, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Dawn McBride, RN
Role: STUDY_DIRECTOR
University of Pittsburgh
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PRO13020474
Identifier Type: -
Identifier Source: org_study_id
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