Foot/Hand Neuromodulation for Overactive Bladder (OAB)

Not Applicable

Terminated

• Conditions: Overactive Bladder
• Interventions: Device: Foot stimulation

• Registration Number: NCT01972061
• Lead Sponsor: Christopher J Chermansky, MD

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.

Study Timeline

• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-23
• Study First Posted: 2013-10-30
• Study Start: 2014-03
• Primary Completion: 2018-12-11
• Study Completion: 2018-12-11
• Results First Submitted: 2019-11-26
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-14
• Last Update Submitted: 2020-02-14
• Results First Posted: 2020-02-26
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 hour hand group	Foot stimulation	Hand stimulation will be applied daily for 3 hours in the evening.
CMG group	Foot stimulation	Foot stimulation will be applied during a cystometrogram (CMG).
3 hours group	Foot stimulation	Foot stimulation will be applied daily for 3 hours in the evening.
1/2 hour group	Foot stimulation	Foot stimulation will be applied daily for 1/2 hour in the evening.

Primary Outcome Measures

Name	Time	Method
Number of Urinary Incontinence Episodes Per Day	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

Name	Time	Method
Number of Urinary Urgency Episodes Per Day	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.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States