Below the Belt: Non-invasive Neuromodulation to Treat Bladder, Bowel, and Sexual Dysfunction Foll… (NCT04604951) | Clinical Trial Compass
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Below the Belt: Non-invasive Neuromodulation to Treat Bladder, Bowel, and Sexual Dysfunction Following Spinal Cord Injury
Canada40 participantsStarted 2022-05-02
Plain-language summary
Recent findings have demonstrated that electrical stimulation to the spinal cord (i.e. implanted electrodes) can significantly recover bladder, bowel, and sexual function after injury. While promising, a major drawback is that individuals must undergo a highly invasive and expensive surgical procedure to implant the stimulator on top of the spinal cord. Moreover, the inability to re-position the implanted stimulator considerably limits the flexibility of this procedure.
In this project, the investigators propose a comprehensive clinical study examining the effects of TCSCS in promoting recovery of these crucial functions in individuals with spinal cord injury (SCI). This non-invasive therapeutic modality uses electrodes applied over the skin to deliver electrical stimulation. It is based on the same principles of ground-breaking work from the investigator's group and others, showing that stimulation of the spinal cord can promote motor and autonomic (cardiovascular, bladder, bowel) recovery in individuals with chronic SCI.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Resident of British Columbia, Canada with active provincial medical services plan
. Male or female, 18-65 years of age
. Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment.
. \>1-year post injury, at least 6 months from any spinal surgery.
. Documented presence of bladder dysfunction (NDO during UDS)
. Documented presence of bowel or sexual dysfunction.
. American Spinal Injury Association Impairment Scale (AIS) A, B.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in bladder capacity measured by urodynamics
Timeframe: Weeks 4-6, Week 19
2
Change in resting anorectal pressure determined via anorectal manometry
. Greater than or equal to antigravity strength in deltoids and biceps bilaterally
Exclusion criteria
. Presence of 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 clinically significant renal or hepatic disease; acute urinary tract infections; pressure sores; active heterotopic ossification; newly changed antidepressant medications \[tricyclics\]; or unstable diabetes. The following conditions apply:
. Moderate and severe forms of renal dysfunctions (eGFR below 60 ml/min)
. Clinically significant abnormal laboratory tests (ALT; Alkaline Phosphatase; Bilirubin \[total\]; GGT) as judged by the investigator.
. Recent treatment with OnabotulinumtoxinA into the detrusor muscle (within 9 months of the baseline visit)
. Ventilator dependent
. Clinically significant depression or ongoing drug abuse
. Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study.