Transcutaneous Spinal Cord Stimulation With Bladder and Pelvic Floor Muscle Training

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Bladder and Pelvic Floor Muscle Training

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Stanmore, United Kingdom, HA7 4LP
    • Royal National Orthopaedic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bladder and Pelvic Floor Muscle Training; 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; 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.
No Intervention: Control; 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?

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

Collaborators and Investigators

• Sponsor: RNOH RIC
• Collaborators: International Spinal Research Trust
• Investigators: Principal Investigator: Frank Lee, Royal National Orthopaedic Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Actual): September 4, 2023
• Study Completion (Actual): September 4, 2023

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Incontinence; Spinal cord stimulation; Bladder overactivity; Neurogenic detrusor overactivity; Pelvic floor physiotherapy
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 304762

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No