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RECRUITING
NCT06515223
NA

Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury

Sponsor: University College, London

View on ClinicalTrials.gov

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

Interventions

DEVICE

Epidural Spinal Cord Stimulation

Epidural Spinal Cord Stimulation Mapping and Pelvic Floor Muscle Training

Locations (1)

Royal National Orthopaedic Hospital

Stanmore, United Kingdom