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

Christopher J Chermansky, MD

Status: Terminated

Conditions: Overactive Bladder

Treatments: Device: Foot stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01972061

PRO13020474

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 4 patient groups

CMG group

Experimental group

Description:

Foot stimulation will be applied during a cystometrogram (CMG).

Treatment:

Device: Foot stimulation

3 hours group

Active Comparator group

Description:

Foot stimulation will be applied daily for 3 hours in the evening.

Treatment:

Device: Foot stimulation

1/2 hour group

Active Comparator group

Description:

Foot stimulation will be applied daily for 1/2 hour in the evening.

Treatment:

Device: Foot stimulation

3 hour hand group

Active Comparator group

Description:

Hand stimulation will be applied daily for 3 hours in the evening.

Treatment:

Device: Foot stimulation