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Neuromodulation Device
High Dose for Spinal Cord Injury (TTNS-RCT Trial)
N/A
Waitlist Available
Led By Argyos Stampas, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Traumatic and non-traumatic SCI performing IC
Up to 2 anticholinergic overactive bladder (OAB) medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after subject enrollment
Awards & highlights
TTNS-RCT Trial Summary
This trial will test whether home transcutaneous tibial nerve stimulation (TTNS) can help improve quality of life for people with spinal cord injury (SCI).
Eligible Conditions
- Spinal Cord Injury
- Neurogenic Bladder
TTNS-RCT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have a spinal cord injury caused by an accident or non-accident and have difficulty controlling your bladder.
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You can take up to two medications for overactive bladder that are anticholinergic.
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You cannot change your medication for Overactive Bladder (OAB) during the study.
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You have a spinal cord injury above the T10 vertebrae level.
Select...
You must be able to speak English or Spanish.
TTNS-RCT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months after subject enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after subject enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with reduced neurogenic bladder symptoms (NGB) as measured by the neurogenic bladder symptom score (NBSS)scale.
Number of participants with reduced neurogenic bladder symptoms (NGB) as measured by the voiding dairy
Number of participants with reduction in bladder medication
Secondary outcome measures
Number of participants with decreased anticholinergic side effects as measured by the anticholinergic side effects survey
Number of participants with improved quality of life as assessed by the I-QOL questionnaire
Number of participants with stable or improved bladder capacity as assessed by the urodynamic study
TTNS-RCT Trial Design
2Treatment groups
Experimental Treatment
Group I: High DoseExperimental Treatment1 Intervention
Group II: ControlExperimental Treatment1 Intervention
Low dose TTNS
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High Dose
2022
Completed Phase 2
~450
Low dose
2016
Completed Phase 4
~470
Find a Location
Who is running the clinical trial?
National Center for Advancing Translational Sciences (NCATS)NIH
319 Previous Clinical Trials
401,680 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,973 Total Patients Enrolled
Argyos Stampas, MDPrincipal InvestigatorUTHealth
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