Improving pelvic rehabilitation after spinal cord injury with epidural stimulation
Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury
This study is testing if using a special device to stimulate the spinal cord can help people with spinal cord injuries improve their bladder and bowel function through pelvic rehabilitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Locations | 1 site (Stanmore) |
| Trial ID | NCT06515223 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance pelvic rehabilitation for individuals with chronic supra-sacral spinal cord injuries through the use of epidural spinal cord stimulation (eSCS). Participants will undergo implantation of an eSCS device, followed by a series of mapping sessions to optimize stimulation parameters for bladder and bowel function. After a 12-week home program, participants will combine eSCS with pelvic floor muscle training to improve their overall pelvic health. The study will assess the effectiveness of this combined approach in managing neurogenic bladder and bowel issues.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with chronic supra-sacral spinal cord injuries and confirmed neurogenic detrusor overactivity.
Not a fit: Patients with transected spinal cords or those with neurodegenerative diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve bladder and bowel function for patients with spinal cord injuries.
How similar studies have performed: Other studies have shown promise with similar neuromodulation techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Spinal Cord Injury (supra-sacral) * AIS A-D * \>18 years; * SCI sustained \>12 months ago; * Neurogenic detrusor overactivity (NDO) confirmed on urodynamics; * Responsive to dorsal genital nerve stimulation * Willing and able to provide informed consent * Stable medical, physical and psychological condition as considered by the investigators * Able to understand and interact with the study team in English * Sufficient upper limb function to operate the device * Suitably optimised bladder and bowel routine Exclusion Criteria: * Transected cord or SCI related to a neurodegenerative disease * Any device or metal work in situ that would exclude the patient from having eSCS implanted * Intra-detrusor botulinum toxin injections within the last 6 months * Previous surgical intervention on bladder sphincters * Any diseases and conditions that would exclude the patient from eSCS and/or surgery, for example, degenerative spinal pathology, syrinx and/or tumor. * Recurrent urinary tract infection refractory to antibiotics * Women who are pregnant or intending to become pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding, or lack of safe contraception for women of childbearing capacity. * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the participant * Participation in another study with investigational drug within the 30 days preceding and during the present study * Enrolment of the investigator, his/her family members, employees, and other dependent persons.
Where this trial is running
Stanmore
- Royal National Orthopaedic Hospital — Stanmore, United Kingdom (Recruiting)
Study contacts
- Principal investigator: David Baxter, MD — National Health Service, United Kingdom
- Study coordinator: Lynsey Duffell, PhD
- Email: l.duffell@ucl.ac.uk
- Phone: 0208 385 3787
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.