Improving bladder function in patients with spinal cord injuries
Restoration of Bladder Function in Spinal Cord Injury
University of Oxford · NCT05968352
This study is testing if using high frequency electrical stimulation can improve bladder function in people with spinal cord injuries who already have stimulation devices.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oxford (other) |
| Locations | 1 site (Oxford, Oxon) |
| Trial ID | NCT05968352 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance bladder function in patients with spinal cord injuries by using electrical stimulation techniques. It will involve 5-10 subjects who already have sacral anterior root stimulation devices implanted, comparing the effects of high frequency stimulation (up to 600Hz) with traditional low frequency stimulation. The research focuses on understanding how these different stimulation frequencies affect bladder and sphincter pressures, as well as overall bladder function. The findings will contribute to the development of better therapies for neurogenic bladder conditions without commercial intent.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with clinically complete spinal cord injuries who have an implanted Finetech Brindley bladder controller.
Not a fit: Patients with external urethral sphincterotomy or those participating in other studies affecting bladder function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved bladder control and quality of life for patients with spinal cord injuries.
How similar studies have performed: While this approach is innovative, similar studies exploring electrical stimulation for bladder function have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with clinically complete spinal cord injury who have undergone implantation of a Finetech Brindley Bladder controller, with or without sacral posterior rhizotomy. * Male or female, aged 18 years or over. * Patients willing and able to give informed consent to involvement in the study Exclusion Criteria: * External urethral sphincterotomy * Patients are taking part in any studies on drugs or devices that alter bladder or autonomic function * Any other significant comorbidity or illness that would preclude their participation or increase the risk to them of participating in the study
Where this trial is running
Oxford, Oxon
- University of Oxford — Oxford, Oxon, United Kingdom (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bladder Dysfunction, Spinal Cord Injuries