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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01972061
Recruitment Status : Terminated (Lack of continued funding)
First Posted : October 30, 2013
Results First Posted : February 26, 2020
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Christopher J Chermansky, MD, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Device: Foot stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Foot/Hand Neuromodulation for Overactive Bladder (OAB)
Study Start Date : March 2014
Actual Primary Completion Date : December 11, 2018
Actual Study Completion Date : December 11, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of Urinary Urgency 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 urgency episodes was calculated for week 1 and week 2 for each subject.


Other Outcome Measures:
  1. Bladder Volume as Recorded on CMG for Strong Desire to Void [ Time Frame: CMG #1 and CMG#2 ]
    Subject reports to the clinic for two CMGs. CMG #1 is the baseline measurement. CMG #2 is recorded during Foot Stimulation

  2. Number of Urinary Voids 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972061


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Christopher J Chermansky, MD
Investigators
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Principal Investigator: Christopher Chermansky, MD University of Pittsburgh
Study Director: Dawn McBride, RN University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Christopher J Chermansky, MD, University of Pittsburgh:
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Responsible Party: Christopher J Chermansky, MD, Assistant Professor of Urology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01972061    
Other Study ID Numbers: PRO13020474
First Posted: October 30, 2013    Key Record Dates
Results First Posted: February 26, 2020
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms