Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury
NCT Number: NCT06515223
Acronym: ImPRESS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Cord Injuries|Neuromodulation|Neurogenic Bladder|Neurogenic Bowel|Neurogenic Detrusor Overactivity
Interventions: DEVICE: Epidural Spinal Cord Stimulation
Sponsor: University College, London
Collaborators: Royal National Orthopaedic Hospital NHS Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-11-01
Locations: Royal National Orthopaedic Hospital, Stanmore, United Kingdom

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.

Primary Outcome Measures: 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 Outcome Measures: Maximum Detrusor Pressure, Maximum recorded detrusor pressure during standard cystometry (retrograde filling of the bladder)., Week 1, 16, 28 and 40|Rectal and Anal Pressure during Push Manoeuvre, During standard anorectal physiology, London protocol., Week 3, 16, 28 and 40|3 day bladder diary, Bladder diary will be completed on clinically used bladder diaries. Participants will record voided volumes, urinary incontinence episodes and daily spasticity for 3 days. This will involve measuring the volume voided each time they urinate over the three days, using provided measuring equipment., Week 3, 12, 16, 28 and 40|Up to 14 day bowel diary, Bowel diary will be completed on clinically used bowel diaries. Participants will record type of stool and amount, bowel incontience, bowel management e.g laxatives, use of manual evacuation., Week 3, 12, 16, 28 and 40|Questionnaire - Neurogenic Bladder Symptom Score (NBSS), Participants will be asked to complete the questionnaire in a private room at RNOH Stanmore., Week 2, 16, 28 and 40|Questionnaire - Urinary Symptom Profile questionnaire, Participants will be asked to complete the questionnaire in a private room at RNOH Stanmore., Week 2, 16, 28 and 40|Questionnaire - Neurogenic Bowel Dysfunction Score (NBDS), Participants will be asked to complete the questionnaire in a private room at RNOH Stanmore., Week 2, 16, 28 and 40|Questionnaire - EQ-5D-5L Quality of Life questionnaire, Participants will be asked to complete the questionnaire in a private room at RNOH Stanmore., Week 2, 16, 28 and 40|Questionnaire - ISCOS Lower Urinary Tract Dysfunction Dataset (LUTDD), Participants will be asked to complete the questionnaire in a private room at RNOH Stanmore., Week 2, 16, 28 and 40|Questionnaire - The International Index of Erectile Function (IIEF) or The Female Sexual Function Index (FSFI), Participants will be asked to complete the questionnaire in a private room at RNOH Stanmore., Week 2, 16, 28 and 40|Questionnaire - Penn Spasm Frequency Scale, Participants will be asked to complete the questionnaire in a private room at RNOH Stanmore., Week 2, 16, 28 and 40|The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), Sensory and motor examination to determine classification of SCI, level of injury and completeness of the injury., Week 2, 16, 28 and 40|Colonic Transit Assessment, A colonic transit study is a test that shows how quickly food passes through the digestive system. Participants will swallow tablets on three consecutive days. On the fourth day, they will have an x-ray., Week 2, 12 and 40|Microbiome Testing, Poo sample will be collected by participant, and bacteria present analysed., Week 2, 16 and 40