Noninvasive Spinal Cord Stimulation for Neurogenic and Idiopathic 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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-24

Study Completion Date

2022-01-01

Brief Summary

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Overactive bladder (OAB) affects 12-30% of the world's population. The accompanying urinary urgency, urinary frequency and incontinence can impair the ability to work, interact in social activities and can result in poor social functioning. Multiple treatment modalities are available for overactive bladder. However, each therapy has drawbacks that limit its application in certain patient populations. For example, oral medications have significant side effects and suffer from poor adherence. Botulinum toxin injection into the bladder wall is invasive, requires re-treatment on a regular basis and carries a risk of urinary retention. Current neuromodulatory techniques are invasive and require highly-specialized care. Therefore, a need exists for a non-invasive, well-tolerated and easily administered therapy for OAB. Transcutaneous spinal cord stimulation (TSCS) has been developed and tested in able bodied individuals to initiate locomotor function as well as in the SCI population for lower extremity and upper extremity function. More recently, we have tested this SCI patients to enable lower urinary tract function and decrease detrusor overactivity, resulting in improved continence.

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Detailed Description

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Conditions

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Overactive Bladder Incontinence, Urge Neurogenic Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinded sham-controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Actual stimulation

Subjects enrolled in the

Group Type EXPERIMENTAL

Noninvasive spinal cord stimulation

Intervention Type DEVICE

Noninvasive spinal cord stimulation is a transcutaneous technique used to modulate the activity of the spinal cord. Subjects will undergo sham or actual stimulation 3-4 times a week for one hour at a time.

Sham stimulation

Group Type SHAM_COMPARATOR

Noninvasive spinal cord stimulation

Intervention Type DEVICE

Noninvasive spinal cord stimulation is a transcutaneous technique used to modulate the activity of the spinal cord. Subjects will undergo sham or actual stimulation 3-4 times a week for one hour at a time.

Interventions

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Noninvasive spinal cord stimulation

Noninvasive spinal cord stimulation is a transcutaneous technique used to modulate the activity of the spinal cord. Subjects will undergo sham or actual stimulation 3-4 times a week for one hour at a time.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age between 18 and 80 years
2. Known diagnosis of overactive bladder, confirmed by:

* presence of urinary frequency, urgency
* frequent small-volume voids on frequency-volume chart
* high score on ICIQ-OAB, ICIQ-OABQOL, and OAB-q questionnaires

Exclusion Criteria

1. Younger than 18 years of age
2. Older than 80 years of age
3. Presence of lower urinary tract symptoms suggestive of urinary retention or obstruction
4. Finding of an elevated post-void residual (\>100 ml) on an ultrasonographic bladder scan
5. History of spinal cord injury, spina bifida or other neurological disease affecting the spinal cord
6. Acute or current urinary tract infection
7. History of neuromodulation for overactive bladder (sacral nerve stimulation or peripheral tibial nerve stimulation)
8. Current or planned pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No