Transcutaneous Spinal Cord Stimulation With Bladder and Pelvic Floor Muscle Training

Study Overview
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Brief Summary
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Spinal Cord Injury (SCI) disrupts signals between the brain and the rest of the body, this includes signals needed to control the bladder and bowels. Spinal cord stimulation (SCS) (electrical stimulation through electrodes placed on the skin over the spine) has shown potential to improve bladder function. Additionally pelvic floor muscle training (PFMT), has been shown to help control bladder overactivity and reduce incontinence in people with a SCI. This study will investigate PFMT with SCS, and its effects on restoring bladder function, and continence. We aim to recruit 25 participants. Those eligible will be patients from the London Spinal Cord Injury Centre with a supra-sacral SCI (>6 months post-injury), aged 16 years old and above.

Detailed Description
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The first five participants who volunteer will be invited to complete 'SCS optimisation'. Testing different SCS electrode positions and stimulation parameters with pelvic floor exercises and during urodynamics (measurement of pressure changes during filling and emptying of the bladder). For the main study, all participants will complete baseline assessments (week 1) which include: bladder, bowel, sexual function, and quality of life questionnaires, a pelvic floor assessment, and urodynamics. Assessments will be repeated at week 8, and week 14. After baseline assessments, participants will be randomly allocated to one of two groups. The intervention group will receive 8-weeks of at home PFMT, this will include 3 face-to-face visits, daily text reminders, and a weekly phone call. The control group will continue with usual care for 8-weeks. At the end of the 8-weeks, all participants will be re-assessed, and will then complete a single session of SCS with urodynamics. Participants will return for their final assessment 6-weeks later (week 14). Participants allocated to the control group will be offered PFMT at the end of the study.

Official Title
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Promoting Restoration of Function of Co-ordinated Bladder Storage and Voiding Following Spinal Cord Injury by Combination of Transcutaneous Spinal Cord Stimulation and Bladder & Pelvic Floor Muscle Training Training

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: Bladder and Pelvic Floor Muscle Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Supra-sacral spinal cord injury over 6 months ago Previous urodynamics and management by the Neuro-urology Consultants Proven NDO from latest urodynamics Exclusion Criteria: Participants under 16 years of age Non-stable SCI or metastatic cord disease Intra-detrusor botulinum toxin injections in previous 6 months Bladder infection on day of investigation Pregnant or trying for a baby (females) Cardiac pacemaker, bladder stimulator or baclofen pump in situ Metal work at thoraco-lumbar level of stimulation Poorly controlled Autonomic Dysreflexia Currently involved in a clinical trial Previous surgical intervention on bladder/sphincters Active sepsis Poorly controlled epilepsy. Acceptable where epilepsy is controlled by drugs or there have been no fits experienced for a reasonable period Patients with a cancerous tumour in the area of the electrical stimulation Patients without the capacity to consent

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bladder and Pelvic Floor Muscle Training<br>Participants randomised to the intervention group will complete an 8-week bladder and PFMT programme, both at the LSCIC and at home. They will be invited to 3 face-to-face follow up appointments over the 8-weeks, where they will meet with a physiotherapist to check their technique and monitor their progress. At home participants will receive a daily text reminder to complete their PFM training, they will also receive a weekly phone call from a member of the research team who will check how they are managing and whether they have any questions. At the end of the programme, participants will be asked to repeat the questionnaires and have their pelvic floor re-assessed. Following this, they will complete the urodynamic investigation with tSCS. | Other: Bladder and Pelvic Floor Muscle Training<br>* The intervention group will receive 8-weeks of at home PFMT, this will include 3 face-to-face visits, daily text reminders, and a weekly phone call.<br>|
| No Intervention: Control<br>Participants randomised to the control group will continue with their usual care for 8-weeks. They will return to repeat their baseline questionnaires and have their pelvic floor re-assessed. Finally, they will complete tSCS bladder filling and emptying cycles with urodynamics. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maximum cystometric capacity (MCC) from baseline to follow up | Bladder capacity from Cystometrogram/Urodynamic procedures (ml) | Week 1, 8 and 14 | 
| Change in maximum detrusor pressure during voiding (MDPvoid) from baseline to follow up | Voiding detrusor pressure measured from Cystometrogram/Urodynamic procedures (cmH20) | Week 1, 8 and 14 | 
| Change in bladder voiding efficiency from baseline to follow up | Bladder voiding efficiency measured from Cystometrogram/Urodynamic procedures, [[volume voided/volume voided+post void residual)*100] (%) | Week 1, 8 and 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic Floor Oxford Grading Score | Measure of pelvic floor muscle strength, graded 0-5 | Week 1, 8 and 14 | 
| The Neurogenic Bladder Symptom Score (NBSS) | Validated 24-item questionnaire, three domains: incontinence, storage and voiding, consequences (score 0-28) | Week 1, 8 and 14 | 
| Neurogenic Bowel Dysfunction Score (NBDS) | Bowel dysfunction questionnaire, includes questions on bowel symptoms, medication, and incontinence (score 0-47) | Week 1, 8 and 14 | 
| Arizona Sexual Experiences Scale (ASEX) | Five-item rating scale measuring sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm (Score 3-30) | Week 1, 8 and 14 | 
| Quality of Life Questionnaire EQ-5D-5L | Five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scoring 1-5 on each dimension, and a VAS scale of overall health 0-100. | Week 1, 8 and 14 | 
| The Qualiveen Questionnaire | 30-item questionnaire, with health-related quality of life questions specific to individuals with neurogenic urinary dysfunction. Total score is mean of eight scores: bother with limitations, fears, feelings, and frequency of limitations. | Week 1, 8 and 14 | 
| Electromyography (EMG) of resting tone and maximum voluntary pelvic floor contraction | Use of vaginal/anal probe to capture resting tone and maximum voluntary pelvic floor contraction (mV) | Week 1, 8 and 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord stimulation, Pelvic floor physiotherapy, Incontinence, Bladder overactivity, Neurogenic detrusor overactivity