Noninvasive Spinal Cord Stimulation for Neurogenic and Idiopathic Overactive Bladder

University of Southern California

Status: Withdrawn

Conditions: Incontinence, Urge; Neurogenic Bladder; Overactive Bladder

Treatments: Device: Noninvasive spinal cord stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03753750

HS-18-00382

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Actual stimulation

Experimental group

Description:

Subjects enrolled in the

Treatment:

Device: Noninvasive spinal cord stimulation

Sham stimulation

Sham Comparator group

Treatment:

Device: Noninvasive spinal cord stimulation