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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
15
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.
Royal National Orthopaedic Hospital
Stanmore, United Kingdom
Change in maximum cystometric capacity (MCC) from baseline to follow up
Bladder capacity from Cystometrogram/Urodynamic procedures (ml)
Time frame: 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)
Time frame: Week 1, 8 and 14
Change in bladder voiding efficiency from baseline to follow up
Bladder voiding efficiency measured from Cystometrogram/Urodynamic procedures, \[\[volume voided/volume voided+post void residual)\*100\] (%)
Time frame: Week 1, 8 and 14
Pelvic Floor Oxford Grading Score
Measure of pelvic floor muscle strength, graded 0-5
Time frame: 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)
Time frame: Week 1, 8 and 14
Neurogenic Bowel Dysfunction Score (NBDS)
Bowel dysfunction questionnaire, includes questions on bowel symptoms, medication, and incontinence (score 0-47)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: Week 1, 8 and 14
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