A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-05-01

Brief Summary

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The purpose of the study is to compare patient centered- outcomes between Transcutaneous Electrical Nerve Stimulation (TENS) at three locations to treat urinary urge incontinence. One of these locations will be along the tibial nerve, which is traditionally accessed near the medial malleolus. The second site will be on the sacral nerve which is accessed over the sacrum. The third site will be a sham site on the shoulder. This study will evaluate the feasibility of transcutaneous electrical stimulation in the treatment of overactive bladder.

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Detailed Description

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Conditions

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Urge Incontinence Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Participants

Study Groups

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Tibial Nerve

Transcutaneous electrical stimulation will be placed on the posterior tibial nerve.

Group Type ACTIVE_COMPARATOR

Transcutaneous Electrical Nerve Stimulation

Intervention Type DEVICE

Parasacral

Transcutaneous electrical stimulation will be placed on the lower back near the s3 foramina.

Group Type ACTIVE_COMPARATOR

Transcutaneous Electrical Nerve Stimulation

Intervention Type DEVICE

Shoulder

Transcutaneous electrical stimulation will be placed on the shoulder.

Group Type SHAM_COMPARATOR

Transcutaneous Electrical Nerve Stimulation

Intervention Type DEVICE

Interventions

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Transcutaneous Electrical Nerve Stimulation

Intervention Type DEVICE

Other Intervention Names

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TENS device

Eligibility Criteria

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Inclusion Criteria

* Patients who are clinically diagnosed with urge incontinence, defined as urinary leakage associated with a sudden, strong desire to pass urine that is difficult to defer.
* Patients with urge predominant mixed incontinence.
* Patients will need to have answered at "Yes" to "leakage related to feeling urgency" on the UDI 6 questionnaire.
* Female
* Over 18 years of age.
* English speaking who are able to give informed consent to participate in the study.
* Patients who have four urinary incontinence episodes.

Exclusion Criteria

* Stress incontinence desiring surgical management.
* Previous treatment of refractory urge incontinence such as PTNS, SNS, or Intradetrusor onabotulinumtoxin A injections.
* Neurological conditions affecting continence such as multiple sclerosis, a history of spinal shock within the past year, or neurologic impairment requiring a wheelchair.
* Urethral diverticulum.
* Daily catheterization due to urinary retention.
* The use of anticholinergic medications for less than 6 weeks.
* Patients who have pacemakers in place.
* Patients with limited mobility requiring a wheelchair.
* Elevated PVR \> 200 cc
* Untreated urinary tract infection, defined as symptoms and a urine culture with greater than 100,000 cfu/ ml within the last 1 month prior to treatment.
* Uncorrected Stage 3 prolapse.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes