Tibial nerve stimulation plus standing to improve pelvic floor and bladder function after spinal cord injury
Changes in Pelvic Floor Function With Tibial Neuromodulation Combined With Standing Therapy
This trial will try combining tibial nerve stimulation with standing therapy in adults with chronic spinal cord injury to see if it improves pelvic floor reflexes, urinary symptoms, and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT07429305 on ClinicalTrials.gov |
What this trial studies
Adults with chronic spinal cord injury and neurogenic lower urinary tract dysfunction undergo baseline questionnaires and electrophysiological testing, then participate in a 12-week program combining assisted standing with tibial nerve stimulation. The study measures changes in pelvic floor reflex excitability, urogenital symptoms, and quality of life before and after the intervention. Investigators will also test how load and posture affect pelvic floor reflexes and whether the combined intervention is feasible and tolerable. Standard exclusions apply, such as implanted electronic devices, lower motor neuron injury, unstable spinal conditions, recent botulinum toxin injections, or contraindications to stimulation or exercise.
Who should consider this trial
Good fit: Ideal candidates are adults (≥19) with chronic SCI between C7–T10 (≥12 months), motor-complete or -incomplete (AIS A–D), who have neurogenic lower urinary tract symptoms and can safely use a standing frame.
Not a fit: People with lower motor neuron injury (e.g., cauda equina syndrome), implanted electronic or metallic devices, unstable spinal disease, recent botulinum toxin injections, or contraindications to stimulation or standing are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could offer a non-invasive therapy to improve bladder control, reduce urinary symptoms, and enhance quality of life for people with chronic spinal cord injury.
How similar studies have performed: Posterior tibial nerve stimulation has shown benefit for bladder symptoms in non-neurogenic and some neurogenic populations, but combining tibial neuromodulation with standing therapy is a novel approach with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 19 years of age * Have a SCI between C7 - T10 that occurred at least 12 months previously * Have a motor-complete or incomplete SCI (AIS A, B, C, or D) * Have symptoms of neurogenic LUT dysfunction * Meet the manufacture requirements for standing frame use (will be evaluated by the research team) * Are able to speak and understand English. Exclusion Criteria: * Have changed their bladder management program in the past month * Have received an injection of Botulinum toxin-A in any LUT structure in the past 2 weeks, or intend to receive an injection while participating in the trial * Have a non-stable SCI (e.g. spinal tumor) * Have signs of a lower motoneuron injury (e.g. cauda equina syndrome) * Have other neurological injury besides SCI * Have an implanted metallic or electronic device (e.g. pace maker, nerve stimulator) * Have a condition for which exercise or transcutaneous stimulation is contraindicated * Have a severe acute medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to acute urinary tract infections, pressure sores, musculoskeletal injury, or unmanage blood pressure. * Are currently pregnant or have given birth within the past 12 months * Use walking as your primary means of movement around your home and the community.
Where this trial is running
Vancouver, British Columbia
- Icord — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Study coordinator: Yao Sun, PhD
- Email: lamlab@icord.org
- Phone: 604-675-8815
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.