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NCT Number: NCT07429305

Combined Tibial Nerve Stimulation and Standing for People With SCI

The goal of this clinical trial is to understand how sensory inputs from the lower leg can influence pelvic floor muscle function and urogential function in adults with chronic spinal cord injury (SCI). The main questions it aims to answer are:

1. What is the modulatory role of load and posture on reflex activation of the pelvic floor muscles in participants with SCI? 2. What is the feasibility of combining tibial neuromodulation with standing therapy in participants with SCI? 3. What are the potential effects of combined tibial neuromodulation and standing therapy on reflex excitability and urogential symptoms and quality of life in people with SCI?

Participants will be asked complete a series of assessments (questionnaires, electrophysiological testing) before and after a 12-week intervention of combined standing and tibial nerve stimulation therapy.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICORD

Vancouver, British Columbia, V5Z 1M0, Canada

Location status: Recruiting

Location contact

Yao Sun, PhD

CONTACT

[email protected]

604-675-8815

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standing + Tibial Nerve Stimulation

Behavioral

Standing (with the support of a standing frame) combined with transcutaneous tibial nerve stimulation 3x/week for 12 weeks.

Primary outcomes

  1. Pelvic Floor Muscle Reflex Excitability

    Time frame: At baseline to within 2 weeks of completing the study intervention

    We will electrically stimulate the tibial nerve and record reflexes responses from the pelvic floor muscles using perianal surface electromyography. We will examine the amplitude of the reflex response.

Secondary outcomes

  1. Feasibility - Recruitment Rate

    Time frame: Through study completion, an average of 8 months

    Recruitment rate will be evaluated by number of participants approached, screened for eligibility, as well as reasons for exclusions.

  2. Feasibility - Adherence

    Time frame: Through study completion, an average of 8 months

    Adherence will be tracked by the compliance of participants to the intervention, with reasons for missed sessions or drop-outs noted.

  3. Feasibility - Adverse Events

    Time frame: Through study completion, an average of 8 months

    Any adverse events to study protocols will be recorded.

  4. Acceptability

    Time frame: Through study completion, an average of 3 months

    The acceptability of the intervention will be evaluated using a 7-point Likert scale to rate participants' opinions about the intervention (enjoyment and perceived benefits) and the outcome measures (tolerability and appropriateness of the measurement procedures). A higher score indicates a more acceptable intervention.

  5. Neurogenic Bladder Symptoms Score (NBSS)

    Time frame: Through study completion, an average of 8 months

    Participants will be asked to respond to 24 questions regarding the severity of their bladder symptoms secondary to neurological injury. Questions cover three subdomains: incontinence, storage and voiding, and consequences. The total score on this questionnaire ranges from 0-74, where a lower score represents less severe symptoms.

  6. Incontinence Quality of Life Questionnaire (I-QoL)

    Time frame: Through study completion, an average of 8 months

    Participants will be asked to respond to 22 questions about how urinary incontinence impacts their quality of life using a 5-point scale with values ranging from 1 (extremely) to 5 (not at all). The questionnaire probes three subdomains of how incontinence may affect quality of life: avoidance and limiting behavior, psychosocial impact, and social embarrassment. Total score on this questionnaire ranges from 0-100, where a higher score represents higher quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Yao Sun, PhD

CONTACT

[email protected]

604-675-8815

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • The Craig H. Neilsen Foundation

Registry information

Official study title

Changes in Pelvic Floor Function With Tibial Neuromodulation Combined With Standing Therapy

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 24, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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