Improving pelvic rehabilitation after spinal cord injury with epidural stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to enhance pelvic rehabilitation for individuals with chronic supra-sacral spinal cord injuries through the use of epidural spinal cord stimulation (eSCS). Participants will undergo implantation of an eSCS device, followed by a series of mapping sessions to optimize stimulation parameters for bladder and bowel function. After a 12-week home program, participants will combine eSCS with pelvic floor muscle training to improve their overall pelvic health. The study will assess the effectiveness of this combined approach in managing neurogenic bladder and bowel issues.

Why it matters

Who can join: the full rules

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.

Where it's running

• Royal National Orthopaedic Hospital
  Stanmore, United Kingdom Recruiting

Study contacts

• Principal investigator: David Baxter, MD — National Health Service, United Kingdom
• Study coordinator: Lynsey Duffell, PhD
• Email: l.duffell@ucl.ac.uk
• Phone: 0208 385 3787

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.