Foot/Hand Neuromodulation for Overactive Bladder (OAB)

Overactive Bladder Clinical Trial

— FootStim  

Official title:

Foot/Hand Neuromodulation for Overactive Bladder (OAB)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01972061
• Other study ID #: PRO13020474
• Status: Terminated
• Phase: N/A
• Start date: March 2014
• Est. completion date: December 11, 2018

Study information

• Verified date: February 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if electrical stimulation of the foot is effective in the treatment of overactive bladder conditions.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: December 11, 2018
• Est. primary completion date: December 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Christopher J Chermansky, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bladder Volume as Recorded on CMG for Strong Desire to Void	Subject reports to the clinic for two CMGs. CMG #1 is the baseline measurement. CMG #2 is recorded during Foot Stimulation	CMG #1 and CMG#2
Other	Number of Urinary Voids Per Day	Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation) and week 3 (post foot stimulation)	Week 1, Week 2, Week 3
Primary	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	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.	Week 1, Week 2, Week 3