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.
Spinal Cord Injury (supra-sacral)
AIS A-D
>18 years;
SCI sustained >12 months ago;
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
Single group
Epidural Spinal Cord Stimulation
DeviceEpidural Spinal Cord Stimulation Mapping and Pelvic Floor Muscle Training
Change in Maximum Cystometric Capacity (bladder capacity) from baseline (week 1) to post intervention (week 16) and follow up (week 28, week 40)
During standard cystometry (retrograde filling of the bladder), maximum cystometric capacity will be defined as the volume emptied from the bladder after each fill.
Maximum Detrusor Pressure
Maximum recorded detrusor pressure during standard cystometry (retrograde filling of the bladder).
Rectal and Anal Pressure during Push Manoeuvre
During standard anorectal physiology, London protocol.
3 day bladder diary
Bladder diary will be completed on clinically used bladder diaries. Participants will record voided volumes, urinary incontinence episodes and daily spasticity for 3 days. This will involve measuring the volume voided each time they urinate over the three days, using provided measuring equipment.
Up to 14 day bowel diary
Bowel diary will be completed on clinically used bowel diaries. Participants will record type of stool and amount, bowel incontience, bowel management e.g laxatives, use of manual evacuation.
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University College, London
Lead sponsor
Royal National Orthopaedic Hospital NHS Trust
Collaborator
