Bladder and Pelvic Floor Muscle Training with Transcutaneous SCS
Research type
Research Study
Full title
Promoting Restoration of Function of Co-ordinated Bladder Storage and Voiding following SCI by Combination of tSCS and Bladder & Pelvic Floor Muscle Training
IRAS ID
304762
Contact name
Sarah Knight
Contact email
Sponsor organisation
Research and Innovation Centre
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Research 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. Loss of continence and voluntary control of emptying not only has a detrimental effect on the quality of life, but can also lead to significant morbidity including recurrent urinary tract infections and potential kidney damage. Restoring bladder and bowel function after a spinal cord injury remains one of the priorities for research and for patients.
Exciting new developments in spinal cord stimulation (electrical stimulation) have shown potential for improving not only mobility, but also bladder and cardiovascular function. Spinal cord stimulation (either through epidural implants, or surface stimulation) for restoring walking is normally associated with extensive rehabilitation programs.
Pelvic floor muscle training (PFMT) with biofeedback has long been known to improve incontinence in people with mixed or stress incontinence. A recent study at our hospital found that 6-weeks of PFMT with biofeedback can provide beneficial effects on voluntary control and reducing incontinence in people with SCI. Greater awareness of pelvic floor musculature may enable greater relaxation to enable bladder emptying.
Therefore, we propose a study which will investigate bladder and pelvic floor muscle training with spinal cord stimulation and its effects in promoting restoration of bladder function, restoring continence and improving voluntary control over voiding. This is a 2-year research project, funded by The International Spinal Research Trust.Summary of results:
Why was the research needed?
Spinal Cord Injury (SCI) disrupts signals between the brain and the rest of the body, this includes signals needed to control the bladder and bowel. People with SCI often experience bladder and bowel urgency (over-activity) and incontinence. 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 over-activity and reduce incontinence in people with a SCI.This study aimed to investigate PFMT combined with SCS, and its effects on restoring bladder function, and continence. We aimed to recruit 20 participants. Those eligible to take part were patients from the London Spinal Cord Injury Centre with a supra-sacral SCI (>6 months post-injury), aged 16 years old and above.
What were the main questions studied?
To determine optimal tSCS electrode position and stimulation parameters for bladder and sphincter function during storage and voiding cycles of bladder function.To determine whether a combination of transcutaneous SCS (tSCS) with bladder and PFMT can increase bladder capacity (how much the bladder holds) and improve voiding efficiency (how well it empties) in people with a supra-sacral SCI.
Who participated in the study?
A total of fourteen participants were recruited to the study (six in phase I, eight in phase II).What treatments or interventions did the participants take/receive?
Phase I: The first six participants who volunteered for the study, completed ‘SCS optimisation’. Different SCS electrode positions (over T11-12, L1-2 spinal levels) and stimulation parameters (1Hz, 15Hz and 30Hz) were tested, in combination with pelvic floor muscle activation, and urodynamics (filling and emptying of the bladder with pressure measurement).Phase II: The next eight participants who volunteered, completed baseline assessments (week 1): bladder, bowel, sexual function, and quality of life questionnaires, a pelvic floor assessment, and urodynamics. This was repeated at week 8 (excluding urodynamics) and week 14.
Participants were randomly allocated to one of two groups. The intervention group received 8-weeks of at home bladder and PFMT, this included 3 face-to-face visits, and a weekly phone call. At the end of the PFMT programme, they completed a single session of SCS with urodynamics. The control group continued with their usual care for 8-weeks and then completed the single session of SCS with urodynamics.
What medical problems (adverse reactions) did the participants have?
There were no medical problems (adverse reactions).What were the results of the study?
Phase I:
Spinal cord stimulation was well tolerated by participants, and there were no adverse events.
Optimal electrode site varied between participants, electrodes at T11-12 or L1-2 demonstrated external anal sphincter reflexes with recruitment curves obtained.
When combining tSCS with pelvic floor muscle contractions, tSCS appeared to increase voluntary pelvic floor muscle strength.
The greatest increase in pelvic floor muscle function was demonstrated at with frequencies of 15Hz and 30Hz.
There was a carryover effect when the stimulation was turned off, pelvic floor muscle strength remained increased compared to control contractions.
15Hz and 30Hz tSCS during urodynamic filling may improve bladder capacity – mean increase in bladder capacity ~65ml.
The effect of tSCS on bladder pressure during filling varied between participants, demonstrating all possibilities - no change, increase and decrease in pressure.
Response to 1Hz and 15Hz tSCS during voiding varied, with participants demonstrating both favourable and unfavourable changes in detrusor voiding pressure and voiding efficiency.Phase II:
Based on Phase I experiments, electrode site and stimulation parameters were standardised for Phase II. Electrode site T11-12, iliac crest, and 30Hz frequency were selected.
The PFMT intervention was well tolerated and adhered to.
There were improvements in pelvic floor muscle function in participants who followed the 8-week PFMT intervention.
Even participants with no palpable pelvic floor contraction and very low EMG activity at baseline improved their pelvic floor motor function.
Improvements in pelvic floor motor function was not associated with improvements in bladder, bowel or sexual function symptoms based on responses to questionnaires. However, some participants self-reported a reduction in incontinence episodes.
When tSCS was applied during urodynamic filling, participants demonstrated improvements in bladder pressure and minimal change in bladder capacity, both with and without voluntary pelvic floor exercises.
Bladder pressure response to tSCS was more favourable in the intervention group.
Further in-depth analysis of Phase 1 and 2 data is on-going including data processing and statistical analysis.SCS is an exciting new development, which can facilitate pelvic floor motor function in SCI. We have demonstrated that a combination of tSCS and intensive 8 week PFMT programme may have a positive impact on lower urinary tract function in people with SCI.
How has this study helped patients and researchers?
This study provides a valuable contribution to the current evidence surrounding spinal cord stimulation. The study enabled the development of protocols for both SCS and assessment of pelvic functions which can be used in further studies. The novelty of this work highlights the potential benefits of spinal cord stimulation in improving pelvic floor muscle function.Details of any further research planned:
The protocols and methods developed within this project were formulated into a research grant application to Brain Research UK and ISRT for a follow on study utilising epidural stimulation to improve bladder and bowel function in people with SCI.
We have successfully been awarded this funding to undertake these projects. The 3-year Brain Research UK funding commenced in October 2023.Where can I learn more about this study?
The study is registered on the clinical trials site, ClinicalTrials.gov ID NCT05504200 The research team is working on publishing the findings of this study in the near future.REC name
London - Harrow Research Ethics Committee
REC reference
22/LO/0039
Date of REC Opinion
8 Mar 2022
REC opinion
Further Information Favourable Opinion