None listed
Conditions
Brief summary
Most people living with spinal cord injury (SCI) develop neurogenic bladder, resulting in restricted social activities and impaired quality of life. Treatments such as bladder neuromodulation with transcutaneous electrical nerve stimulation (TENS) have been shown to improve bladder function in SCI without adverse effects. We aim to develop a daily home TENS protocol of self-administration. We hypothesise that using TENS at home is safe and feasible to be performed in people with chronic SCI. This study could pioneer a non-invasive, cost-effective and convenient solution to treat neurogenic bladder dysfunction with self-care at home, in order to significantly improve overall health-related quality of life for individuals with SCI.
Interventions
- All participants will receive transcutaneous electrical nerve stimulation (TENS) using an FDA-approved device via skin-surface electrodes to stimulate the S3 dermatomes by self-administration or caregiver 15 minutes daily for 4 weeks in their homes.
- Participants will receive treatment with 50 mA intensities, stimulation frequency of 25 Hz and pulse width of 400 µs in burst mode (4-second stimulation and 1-second pause) during 15 minutes, Auto-Off stimulation.
- Participants and/or caregiver
- All participants will receive transcutaneous electrical nerve stimulation (TENS) using an FDA-approved device via skin-surface electrodes to stimulate the S3 dermatomes by self-administration or caregiver 15 minutes daily for 4 weeks in their homes. - Participants will receive treatment with 50 mA intensities, stimulation frequency of 25 Hz and pulse width of 400 µs in burst mode (4-second stimulation and 1-second pause) during 15 minutes, Auto-Off stimulation. - Participants and/or caregivers will be given a video demonstration of the TENS procedure prior to commencement. Training will be provided by the investigator via a VDO conference and available on the webpage. - Participants will be monitored weekly (for 4 weeks) via phone calls or VDO conferences to check TENS-protocol, self-report bladder diary and adverse events.
Sponsors
University of Auckland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
• 18-75 years old • Neurologically stable SCI for => 12 months • SCI may have varying causes: traumatic and non-traumatic SCI e.g., infection, tumours, disc herniation, etc. • Level of injury T12 or above (upper motor neuron bladder dysfunction) with no lower motor neuron lesions • Intermittent catheterisation to empty bladder • Stable bladder, no symptoms of urinary tract infection • Medically stable for urination => 3 months • Able to understand risks and benefits of participating in the study
Exclusion criteria
• Normal voluntary urination control at home • Other diagnoses to explain incontinence (urinary tract infection, bladder stones, multiple sclerosis, traumatic brain injury, stroke, etc.) • Cutaneous pathology preventing electrode placement e.g., bedsore, pressure ulcer at the perineum • Known lower motor neuron pathology to the sacral nerve, bladder or the lower urinary tract • History of autonomic dysreflexia • Inability to participate in assessments due to dementia, cognitive impairment, language difficulties • Current pregnancy, febrile pathology, urinary tract infection, cachexia, malignant cancer, cancer at the stimulation site • Demand-type cardiac pacemaker or implanted defibrillator
Outcome results
None listed