Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury

Launched by UNIVERSITY COLLEGE, LONDON · Jul 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help improve bladder and bowel function in people who have had a spinal cord injury (SCI). Specifically, the trial focuses on using a device called an epidural spinal cord stimulator (eSCS). The goal is to see if this device can help reduce bladder overactivity, improve bowel function, and enhance overall quality of life. Participants in the trial will be those who have had a spinal cord injury above the sacral region for more than 12 months and have certain bladder issues confirmed through testing.

If you qualify and decide to participate, you will first undergo some tests to ensure the eSCS is right for you. After that, the device will be implanted and you'll have the opportunity to use it at home for 12 weeks. During this time, you’ll also learn exercises to help strengthen your bladder and pelvic floor muscles. Throughout the study, your bladder and bowel function, as well as your quality of life, will be assessed to see how well the treatment is working. It's important to know that you should be stable in your overall health and able to follow the study's procedures to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Spinal Cord Injury (supra-sacral)
• • AIS A-D
• • \>18 years;
• • SCI sustained \>12 months ago;
• • Neurogenic detrusor overactivity (NDO) confirmed on urodynamics;
• • Responsive to dorsal genital nerve stimulation
• • Willing and able to provide informed consent
• • Stable medical, physical and psychological condition as considered by the investigators
• • Able to understand and interact with the study team in English
• • Sufficient upper limb function to operate the device
• • Suitably optimised bladder and bowel routine
• Exclusion Criteria:
• • 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
• • Any diseases and conditions that would exclude the patient from eSCS and/or surgery, for example, degenerative spinal pathology, syrinx and/or tumor.
• • Recurrent urinary tract infection refractory to antibiotics
• • Women who are pregnant or intending to become pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding, or lack of safe contraception for women of childbearing capacity.
• • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the participant
• • Participation in another study with investigational drug within the 30 days preceding and during the present study
• • Enrolment of the investigator, his/her family members, employees, and other dependent persons.