Transcutaneous Spinal Cord Stimulation With Bladder and Pelvic Floor Muscle Training

NCT05504200 | Completed

• 1 other identifier: 304762
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Spinal cord stimulation; Pelvic floor physiotherapy; Incontinence; Bladder overactivity; Neurogenic detrusor overactivity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Pelvic Floor Oxford Grading Score

  Week 1, 8 and 14

• The Neurogenic Bladder Symptom Score (NBSS)

  Week 1, 8 and 14

• Neurogenic Bowel Dysfunction Score (NBDS)

  Week 1, 8 and 14

• Arizona Sexual Experiences Scale (ASEX)

  Week 1, 8 and 14

• Quality of Life Questionnaire EQ-5D-5L

  Week 1, 8 and 14

Study Arms (2)

Bladder and Pelvic Floor Muscle Training

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Bladder and Pelvic Floor Muscle Training OTHER

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.

Bladder and Pelvic Floor Muscle Training

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Supra-sacral spinal cord injury over 6 months ago
• Previous urodynamics and management by the Neuro-urology Consultants
• Proven NDO from latest urodynamics

You may not qualify if:

• 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

Sponsors & Collaborators

• RNOH RIC: lead
• International Spinal Research Trust: collaborator

Study Sites (1)

Royal National Orthopaedic Hospital

Stanmore, HA7 4LP, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 35778466 BACKGROUND

• 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.

  PMID: 30008661 BACKGROUND

• 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.

  PMID: 31956301 BACKGROUND

• 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.

  PMID: 32355163 BACKGROUND

• 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.

  PMID: 32759239 BACKGROUND

• 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.

  PMID: 29574482 BACKGROUND

• 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.

  PMID: 26238317 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Frank Lee

  Royal National Orthopaedic Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Research and Innovation

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 17, 2022
• Study Start: March 16, 2022
• Primary Completion: September 4, 2023
• Study Completion: September 4, 2023
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)