Below the Belt: Non-invasive Neuromodulation to Treat Bladder, Bowel, and Sexual Dysfunction Following Spinal Cord Injury

Launched by UNIVERSITY OF BRITISH COLUMBIA · Oct 25, 2020

Keywords

ClinConnect Summary

This clinical trial, called "Below the Belt," is exploring a new and non-invasive way to help people with spinal cord injuries regain bladder, bowel, and sexual functions. Traditionally, patients have needed a surgical procedure to implant electrodes on the spinal cord, but this trial is testing a method that uses electrodes placed on the skin instead. This approach could provide a more flexible and less invasive treatment option for individuals experiencing these challenges after a spinal cord injury.

To participate in this study, individuals must be between 18 and 65 years old, have had a spinal cord injury for more than a year, and experience bladder dysfunction along with bowel or sexual dysfunction. Participants should also be able to perform certain tasks, like catheterization, either independently or with help. If eligible, participants will receive the non-invasive electrical stimulation treatment and will be asked to attend regular clinic visits to monitor their progress. It's important to note that women who can become pregnant must use effective contraception during the trial, and all participants will need to give informed consent before joining. This study aims to improve the quality of life for those affected by spinal cord injuries, and the findings could lead to better treatment options in the future.

Gender

ALL

Eligibility criteria

• A participant must meet all of the following criteria in order to be eligible for inclusion:
• • 1. Resident of British Columbia, Canada with active provincial medical services plan
• • 2. Male or female, 18-65 years of age
• • 3. Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment.
• • 4. \>1-year post injury, at least 6 months from any spinal surgery.
• • 5. Documented presence of bladder dysfunction (NDO during UDS)
• • 6. Documented presence of bowel or sexual dysfunction.
• • 7. American Spinal Injury Association Impairment Scale (AIS) A, B.
• • 8. Greater than or equal to antigravity strength in deltoids and biceps bilaterally
• • 9. Hand function sufficient to perform Clean Intermittent Catheterization (CIC) or a committed caregiver to provide CIC for management of urinary bladder drainage.
• • 10. Participants must have documented three days of bladder and bowel history prior to their baseline visit.
• • 11. Willing and able to comply with all clinic visits and study-related procedures. Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
• • 12. No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing activities.
• • 13. Stable management of spinal cord related clinical issues (i.e., spasticity management).
• 14. Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
• • 15. Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit. During the trial, all women of childbearing potential will undergo urine pregnancy tests at their monthly clinic visits as outlined in the schedule of events.
• • Women of childbearing potential must agree to use adequate contraception\*\~2\~\* during the period of the trial and for at least 28 days after completion of treatment.
• • 16. Effective contraception includes abstinence. Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.
• • 17. Must provide informed consent.
• Exclusion Criteria:
• A participant who meets any of the following criteria will be ineligible to participate:
• 1. 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:
• • 1. Moderate and severe forms of renal dysfunctions (eGFR below 60 ml/min)
• • 2. Clinically significant abnormal laboratory tests (ALT; Alkaline Phosphatase; Bilirubin \[total\]; GGT) as judged by the investigator.
• • 2. Recent treatment with OnabotulinumtoxinA into the detrusor muscle (within 9 months of the baseline visit)
• • 3. Ventilator dependent
• • 4. Clinically significant depression or ongoing drug abuse
• • 5. 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.
• • 6. Intrathecal baclofen pump.
• • 7. Cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
• • 8. Any implanted metal in trunk or spinal cord under the sites of application of electrodes (between anode and cathode) for those who are allocated to receive TCSCS.
• • 9. Severe anemia (Hgb\<8 g/dl) or hypovolemia
• • 10. Participant is a member of the investigational team or his /her immediate family.
• • 11. Participant has undergone electrode implantation surgery.