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Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury
Sponsor: University College, London
Summary
The investigators will recruit up to 20 volunteers with chronic, supra-sacral SCI. Following screening, eligible participants will enter 'Phase I', they will complete baseline outcome measures and then have the epidural spinal cord stimulator (eSCS) implanted with either percutaneous or paddle electrodes. Preoperative and intraoperative testing will determine exact location of electrodes. Mapping and optimisation of stimulation parameters will be performed simultaneously with urodynamic investigations of bladder function, and anorectal physiology investigations of bowel function. The acute effects of eSCS to suppress bladder overactivity, facilitate voiding, prevent unwanted reflex sphincter activity, and pelvic floor function will guide development of eSCS programmes for use at home. In 'Phase II', participants will use eSCS at home for 12-weeks. Participants will also be taught how to perform bladder and pelvic floor muscle training (PFMT) in combination with eSCS. Outcome measures assessing bladder, bowel, sexual function, quality of life, motor function and spasticity will be captured prior to and following the 12-week intervention, and at 3 and 6 month follow up.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-10-14
Completion Date
2027-11-01
Last Updated
2025-03-14
Healthy Volunteers
No
Conditions
Interventions
Epidural Spinal Cord Stimulation
Epidural Spinal Cord Stimulation Mapping and Pelvic Floor Muscle Training
Locations (1)
Royal National Orthopaedic Hospital
Stanmore, United Kingdom