Transcutaneous Spinal Cord Stimulation With Bladder and Pelvic Floor Muscle Training

Sponsor

Iva Hauptmannova (Other)

Overall Status

Recruiting

CT.gov ID

NCT05504200

Collaborator

International Spinal Research Trust (Other)

Enrollment

Location

Arms

17.5

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries	Other: Bladder and Pelvic Floor Muscle Training	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 16, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in maximum cystometric capacity (MCC) from baseline to follow up [Week 1, 8 and 14]
Bladder capacity from Cystometrogram/Urodynamic procedures (ml)
Change in maximum detrusor pressure during voiding (MDPvoid) from baseline to follow up [Week 1, 8 and 14]
Voiding detrusor pressure measured from Cystometrogram/Urodynamic procedures (cmH20)
Change in bladder voiding efficiency from baseline to follow up [Week 1, 8 and 14]
Bladder voiding efficiency measured from Cystometrogram/Urodynamic procedures, [[volume voided/volume voided+post void residual)*100] (%)

Secondary Outcome Measures

Pelvic Floor Oxford Grading Score [Week 1, 8 and 14]
Measure of pelvic floor muscle strength, graded 0-5
The Neurogenic Bladder Symptom Score (NBSS) [Week 1, 8 and 14]
Validated 24-item questionnaire, three domains: incontinence, storage and voiding, consequences (score 0-28)
Neurogenic Bowel Dysfunction Score (NBDS) [Week 1, 8 and 14]
Bowel dysfunction questionnaire, includes questions on bowel symptoms, medication, and incontinence (score 0-47)
Arizona Sexual Experiences Scale (ASEX) [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)
Quality of Life Questionnaire EQ-5D-5L [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.
The Qualiveen Questionnaire [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.
Electromyography (EMG) of resting tone and maximum voluntary pelvic floor contraction [Week 1, 8 and 14]
Use of vaginal/anal probe to capture resting tone and maximum voluntary pelvic floor contraction (mV)

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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