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Neuromodulation Device

Noninvasive spinal cord stimulation for Neurogenic Bladder

N/A
Waitlist Available
Led By Evgeniy I Kreydin
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-12 weeks
Awards & highlights

Summary

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.

Eligible Conditions
  • Neurogenic Bladder
  • Urge Incontinence
  • Overactive Bladder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of urination and incontinence episodes over 72 hours
Score on overactive bladder questionnaires
Secondary outcome measures
Cystometric bladder capacity, number of detrusor overactivity episodes during urodynamic studies.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Actual stimulationExperimental Treatment1 Intervention
Subjects enrolled in the
Group II: Sham stimulationPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
936 Previous Clinical Trials
1,613,481 Total Patients Enrolled
University of California, Los AngelesOTHER
1,554 Previous Clinical Trials
10,264,114 Total Patients Enrolled
Evgeniy I KreydinPrincipal InvestigatorUniversity of Southern California
~0 spots leftby Sep 2025