Actively Recruiting
Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury
Led by University College, London · Updated on 2025-03-14
20
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
R
Royal National Orthopaedic Hospital NHS Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Spinal Cord Injury (supra-sacral)
- AIS A-D
- 18 years or older
- Spinal cord injury sustained more than 12 months ago
- Neurogenic detrusor overactivity confirmed by urodynamics
- Responsive to dorsal genital nerve stimulation
- Willing and able to provide informed consent
- Stable medical, physical, and psychological condition
- Able to understand and communicate in English
- Sufficient upper limb function to operate the device
- Optimized bladder and bowel routine
You will not qualify if you...
- Transected spinal cord or SCI due to neurodegenerative disease
- Presence of any device or metal work that prevents eSCS implantation
- Botulinum toxin injections in the bladder within the last 6 months
- Previous surgical intervention on bladder sphincters
- Diseases excluding eSCS or surgery, such as degenerative spinal pathology, syrinx, or tumor
- Recurrent urinary tract infections resistant to antibiotics
- Women who are pregnant, breastfeeding, or not using safe contraception
- Inability to follow study procedures due to language, psychological disorders, or dementia
- Participation in another investigational drug study within 30 days prior or during this study
- Investigator, their family members, employees, or dependents enrolled in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Royal National Orthopaedic Hospital
Stanmore, United Kingdom
Actively Recruiting
Research Team
L
Lynsey Duffell, PhD
CONTACT
H
Hannah Houliston, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here