Clinical trial NCT05504200: Transcutaneous Spinal Cord Stimulation With Bladder and Pelvic Floor Muscle Training
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal cord stimulation
Pelvic floor physiotherapy
Incontinence
Bladder overactivity
Neurogenic detrusor overactivity
Lead sponsor: Royal National Orthopaedic Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: International Spinal Research Trust
First posted: 2022-08-17
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in maximum cystometric capacity (MCC) from baseline to follow up
timeFrame: Week 1, 8 and 14
measure: Change in maximum detrusor pressure during voiding (MDPvoid) from baseline to follow up
timeFrame: Week 1, 8 and 14
measure: Change in bladder voiding efficiency from baseline to follow up
timeFrame: Week 1, 8 and 14
Secondary outcomes:
measure: Pelvic Floor Oxford Grading Score
timeFrame: Week 1, 8 and 14
measure: The Neurogenic Bladder Symptom Score (NBSS)
timeFrame: Week 1, 8 and 14
measure: Neurogenic Bowel Dysfunction Score (NBDS)
timeFrame: Week 1, 8 and 14
measure: Arizona Sexual Experiences Scale (ASEX)
timeFrame: Week 1, 8 and 14
measure: Quality of Life Questionnaire EQ-5D-5L
timeFrame: Week 1, 8 and 14
measure: The Qualiveen Questionnaire
timeFrame: Week 1, 8 and 14
measure: Electromyography (EMG) of resting tone and maximum voluntary pelvic floor contraction
timeFrame: Week 1, 8 and 14
Other outcomes:
Locations:
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital
Study officials:
affiliation: Royal National Orthopaedic Hospital
name: Frank Lee
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herrity AN, Aslan SC, Mesbah S, Siu R, Kalvakuri K, Ugiliweneza B, Mohamed A, Hubscher CH, Harkema SJ. Targeting bladder function with network-specific epidural stimulation after chronic spinal cord injury. Sci Rep. 2022 Jul 1;12(1):11179. doi: 10.1038/s41598-022-15315-2.
citation: Gad PN, Kreydin E, Zhong H, Latack K, Edgerton VR. Non-invasive Neuromodulation of Spinal Cord Restores Lower Urinary Tract Function After Paralysis. Front Neurosci. 2018 Jun 29;12:432. doi: 10.3389/fnins.2018.00432. eCollection 2018.
citation: Doherty S, Vanhoestenberghe A, Duffell L, Hamid R, Knight S. A Urodynamic Comparison of Neural Targets for Transcutaneous Electrical Stimulation to Acutely Suppress Detrusor Contractions Following Spinal Cord Injury. Front Neurosci. 2019 Dec 17;13:1360. doi: 10.3389/fnins.2019.01360. eCollection 2019.
citation: Doherty SP, Vanhoestenberghe A, Duffell LD, Hamid R, Knight SL. Ambulatory urodynamic monitoring assessment of dorsal genital nerve stimulation for suppression of involuntary detrusor contractions following spinal cord injury: a pilot study. Spinal Cord Ser Cases. 2020 Apr 30;6(1):30. doi: 10.1038/s41394-020-0279-4.
citation: Xu L, Fu C, Zhang Q, Xiong F, Peng L, Liang Z, Chen L, He C, Wei Q. Efficacy of biofeedback, repetitive transcranial magnetic stimulation and pelvic floor muscle training for female neurogenic bladder dysfunction after spinal cord injury: a study protocol for a randomised controlled trial. BMJ Open. 2020 Aug 5;10(8):e034582. doi: 10.1136/bmjopen-2019-034582.
citation: Elmelund M, Biering-Sorensen F, Due U, Klarskov N. The effect of pelvic floor muscle training and intravaginal electrical stimulation on urinary incontinence in women with incomplete spinal cord injury: an investigator-blinded parallel randomized clinical trial. Int Urogynecol J. 2018 Nov;29(11):1597-1606. doi: 10.1007/s00192-018-3630-6. Epub 2018 Mar 24.
citation: Vasquez N, Knight SL, Susser J, Gall A, Ellaway PH, Craggs MD. Pelvic floor muscle training in spinal cord injury and its impact on neurogenic detrusor over-activity and incontinence. Spinal Cord. 2015 Dec;53(12):887-9. doi: 10.1038/sc.2015.121. Epub 2015 Aug 4.