Foot/Hand Neuromodulation for Overactive Bladder (OAB)

NCT ID: NCT01972061

Last Updated: 2020-02-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-12-11

Brief Summary

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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

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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.

Conditions

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Overactive Bladder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CMG group

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

Group Type EXPERIMENTAL

Foot stimulation

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Foot stimulation

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Foot stimulation

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Foot stimulation

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Christopher J Chermansky, MD

OTHER

Sponsor Role lead

Responsible Party

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Christopher J Chermansky, MD

Assistant Professor of Urology

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PRO13020474

Identifier Type: -

Identifier Source: org_study_id

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