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
43 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
This research aims to improve pelvic rehabilitation for adults with chronic, supra-sacral spinal cord injury (SCI) by evaluating the use of epidural spinal cord stimulation (eSCS) combined with pelvic floor muscle training. Up to 20 volunteers will participate, all having confirmed neurogenic detrusor overactivity (NDO) and responsiveness to dorsal genital nerve stimulation. The study focuses on assessing bladder, bowel, sexual function, quality of life, motor function, and spasticity over time. The study includes two main phases. In Phase I, participants will have a Senza implantable pulse generator placed under the skin, with electrodes positioned to target bladder, bowel, and pelvic floor muscles. Mapping sessions will identify effective stimulation settings for home use. Participants will learn pelvic floor muscle exercises to perform alongside eSCS. Phase II involves a 12-week home trial using these stimulation programs and exercises, with regular clinic visits and weekly phone calls for support and progress review. Participants will undergo extensive assessments including urodynamics, anorectal physiology, bladder and bowel diaries, and various questionnaires before and after the intervention, as well as at 3 and 6 months follow-up. They will be offered the choice to keep or have the eSCS device removed after the trial. Researchers will continue to monitor all participants long-term to evaluate changes in bladder capacity and other key outcomes, ensuring comprehensive safety and effectiveness tracking throughout the study period.
CONDITIONS
Brief Title
Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged over 18 years
- Supra-sacral spinal cord injury (SCI)
- AIS A-D classification
- SCI sustained more than 12 months ago
- Neurogenic detrusor overactivity confirmed by urodynamics
- Responsive to dorsal genital nerve stimulation
- Able and willing to provide informed consent
- Stable medical, physical, and psychological condition
- Able to understand and communicate in English
- Sufficient upper limb function to operate device
- Optimized bladder and bowel management routine
You will not qualify if you...
- Transected spinal cord or SCI related to neurodegenerative disease
- Presence of devices or metal work preventing eSCS implantation
- Botulinum toxin injections in bladder within last 6 months
- Previous bladder sphincter surgery
- Other diseases excluding eSCS or surgery (degenerative spinal pathology, syrinx, tumor)
- Recurrent urinary tract infection not responsive to antibiotics
- Pregnant, breastfeeding, or lacking safe contraception if of childbearing potential
- Inability to follow study procedures due to language, psychological, or cognitive issues
- Participation in another investigational drug study within 30 days
- Investigator, family, employees, or dependent persons enrolled in the study
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Multiple visits to meet multidisciplinary team members and undergo urodynamics assessment, with additional assessments if eligible
Duration - Approximate duration of initial implantation and mapping phase before home use
Participants undergo implantation of an epidural spinal cord stimulation device and complete baseline measurements. They attend mapping sessions to determine stimulation sites and parameters, and are taught a pelvic floor muscle training programme.
3 mapping sessions and initial assessments
Duration - 12 weeks
Participants use their epidural spinal cord stimulation programmes daily and complete pelvic floor muscle training at home. They attend pelvic floor clinic visits to review and progress their exercises and receive weekly phone calls for support.
Pelvic floor clinic visits at weeks 3, 6, and 9; weekly phone calls; daily home use
Duration - Up to 6 months after treatment
Participants are followed up at 3 and 6 months after the treatment period for outcome reassessments and to discuss whether to keep or have the device explanted. Those who keep the device complete additional diary assessments without stimulation.
Visits at 3 and 6 months; device explant decision discussions; diary assessments during stimulation off period
Trial Site Locations
Total: 1 location
1
Royal National Orthopaedic Hospital
Stanmore, United Kingdom
Actively Recruiting
Research Team
L
Lynsey Duffell, PhD
H
Hannah Houliston, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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