Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury

NCT06515223 | Recruiting

• 1 other identifier: 301613
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries; Neuromodulation; Neurogenic Bladder; Neurogenic Bowel; Neurogenic Detrusor Overactivity

Outcome Measures

Primary Outcomes (1)

• Change in Maximum Cystometric Capacity (bladder capacity) from baseline (week 1) to post intervention (week 16) and follow up (week 28, week 40)

  During standard cystometry (retrograde filling of the bladder), maximum cystometric capacity will be defined as the volume emptied from the bladder after each fill.

  Week 1, 16, 28 and 40

Secondary Outcomes (14)

• Maximum Detrusor Pressure

  Week 1, 16, 28 and 40

• Rectal and Anal Pressure during Push Manoeuvre

  Week 3, 16, 28 and 40

• 3 day bladder diary

  Week 3, 12, 16, 28 and 40

• Up to 14 day bowel diary

  Week 3, 12, 16, 28 and 40

• Questionnaire - Neurogenic Bladder Symptom Score (NBSS)

  Week 2, 16, 28 and 40

Study Arms (1)

Treatment

EXPERIMENTAL

Implantation of Epidural Spinal Cord Stimulation to target bladder and bowel function. Applied in combination with Pelvic Floor Muscle Training.

Device: Epidural Spinal Cord Stimulation

Interventions

Epidural Spinal Cord Stimulation DEVICE

Epidural Spinal Cord Stimulation Mapping and Pelvic Floor Muscle Training

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead
• Royal National Orthopaedic Hospital NHS Trust: collaborator

Study Sites (1)

Royal National Orthopaedic Hospital

Stanmore, United Kingdom

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic; Neurogenic Bowel

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• David Baxter, MD

  National Health Service, United Kingdom

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynsey Duffell, PhD

CONTACT

0208 385 3787; l.duffell@ucl.ac.uk

Hannah Houliston, PhD

CONTACT

02039470291; hannah.houliston@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 23, 2024
• Study Start: October 14, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 14, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)