Transcutaneous Spinal Cord Stimulation With Bladder and Pelvic Floor Muscle Training (NCT05504200) | Clinical Trial Compass
CompletedNot Applicable
Transcutaneous Spinal Cord Stimulation With Bladder and Pelvic Floor Muscle Training
United Kingdom15 participantsStarted 2022-03-16
Plain-language 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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in maximum cystometric capacity (MCC) from baseline to follow up
Timeframe: Week 1, 8 and 14
2
Change in maximum detrusor pressure during voiding (MDPvoid) from baseline to follow up
Timeframe: Week 1, 8 and 14
3
Change in bladder voiding efficiency from baseline to follow up