ImPRESS
Research type
Research Study
Full title
Improving Pelvic Rehabilitation using Epidural Stimulation after SCI
IRAS ID
301613
Contact name
Lynsey Duffell
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Following spinal cord injury (SCI) signals between the brain and the bladder are disrupted. As a result the bladder often becomes overactive which can lead to the need for frequent trips to the toilet, regular incontinence episodes and a decreased quality-of-life. Studies using epidural spinal cord stimulation (eSCS) for physical rehabilitation after SCI have noted important improvements in bladder and bowel control. As the eSCS was not programmed to target this in these studies, the potential benefits may be substantially more than already reported.
We will recruit up to 20 volunteers with chronic SCI. In phase I, participants will undergo a procedure to implant the eSCS electrodes and device (stimulator). Bladder and bowel function assessments will be performed with and without the stimulation. The acute effects of eSCS to suppress bladder overactivity, facilitate voiding, prevent unwanted reflex sphincter activity, and pelvic floor function will be investigated. Additionally, programmes will be created for participants to use at home alongside their bladder and bowel routine.
In phase II, participants will trial using the eSCS programmes at home for 12-weeks, and be asked to complete a 3-day bladder diary and up to 14-day bowel diary towards the end of the 12-weeks. Participants will also be taught how to perform bladder and pelvic floor muscle training in combination with eSCS, with three face to face follow up sessions.
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.
This trial aims to validate the application of eSCS for bladder, bowel and sexual function, which may rapidly and substantially benefit the SCI population.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
24/ES/0056
Date of REC Opinion
5 Aug 2024
REC opinion
Further Information Favourable Opinion