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Completed

NCT Number: NCT05504200

Transcutaneous Spinal Cord Stimulation With Bladder and Pelvic Floor Muscle 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.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal National Orthopaedic Hospital

Stanmore, HA7 4LP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in maximum cystometric capacity (MCC) from baseline to follow up

    Time frame: Week 1, 8 and 14

    Bladder capacity from Cystometrogram/Urodynamic procedures (ml)

  2. Change in maximum detrusor pressure during voiding (MDPvoid) from baseline to follow up

    Time frame: Week 1, 8 and 14

    Voiding detrusor pressure measured from Cystometrogram/Urodynamic procedures (cmH20)

  3. Change in bladder voiding efficiency from baseline to follow up

    Time frame: Week 1, 8 and 14

    Bladder voiding efficiency measured from Cystometrogram/Urodynamic procedures, [[volume voided/volume voided+post void residual)*100] (%)

Secondary outcomes

  1. Pelvic Floor Oxford Grading Score

    Time frame: Week 1, 8 and 14

    Measure of pelvic floor muscle strength, graded 0-5

  2. The Neurogenic Bladder Symptom Score (NBSS)

    Time frame: Week 1, 8 and 14

    Validated 24-item questionnaire, three domains: incontinence, storage and voiding, consequences (score 0-28)

  3. Neurogenic Bowel Dysfunction Score (NBDS)

    Time frame: Week 1, 8 and 14

    Bowel dysfunction questionnaire, includes questions on bowel symptoms, medication, and incontinence (score 0-47)

  4. Arizona Sexual Experiences Scale (ASEX)

    Time frame: Week 1, 8 and 14

    Five-item rating scale measuring sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm (Score 3-30)

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

    Time frame: Week 1, 8 and 14

    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.

  6. The Qualiveen Questionnaire

    Time frame: Week 1, 8 and 14

    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.

  7. Electromyography (EMG) of resting tone and maximum voluntary pelvic floor contraction

    Time frame: Week 1, 8 and 14

    Use of vaginal/anal probe to capture resting tone and maximum voluntary pelvic floor contraction (mV)

Sponsors and collaborators

Lead sponsor

RNOH RIC

Other

Collaborators

  • International Spinal Research Trust

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2022
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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