N/A
N=50
Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation
Chronic Spinal Cord Injury · Neurogenic Bladder
Bottom Line
View on ClinicalTrials.gov: NCT04074616 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Number of Participants With Reduction in Bladder Medication — 19; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High Dose (Device); Low dose (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Reduction in Bladder Medication |
19; 15 | — |
| PRIMARY Number of Participants With a Change in Neurogenic Bladder Symptom Score (NBSS) Scale From Baseline |
8; 7; 7; 11; 1; 3 | — |
| PRIMARY Number of Participants With Reduced Neurogenic Bladder Symptoms (NGB) as Measured by the Voiding Diary |
0; 0 | — |
| SECONDARY Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline |
4; 6; 6; 4; 7; 11 | — |
| SECONDARY Number of Participants With Decreased Anticholinergic Side Effects as Measured by the Anticholinergic Side Effects Survey |
0; 0 | — |
| SECONDARY Number of Participants With Increased or Stable Bladder Capacity as Assessed by the Urodynamic Study |
12; 14 | — |
Summary
The purpose of this study is to determine the efficacy of home transcutaneous tibial nerve stimulation (TTNS) in spinal cord injury(SCI) and to determine the impact on quality of life using TTNS at home
Eligibility Criteria
Inclusion Criteria
- Traumatic and non-traumatic SCI performing IC
- Up to 2 anticholinergic overactive bladder (OAB) medications
- No changes in OAB medications
- Neurologic level of injury above T10
- English and Spanish speaking
Exclusion Criteria
- Past history of genitourinary diagnoses or surgeries
- History of central nervous system (CNS) disorders and/or peripheral neuropathy
- Pregnancy
- Lower motor neuron bladder
- Concern for tibial nerve pathway injury
- Absence of toe flexion or AD with electric stimulation
- Bladder chemodenervation in past 6 months
- Potential for progressive SCI including neurodegenerative SCI, ALS, cancer myelopathy, Multiple sclerosis, transverse myelitis
Data sourced from ClinicalTrials.gov (NCT04074616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.