Spinal Cord Injuries Clinical Trial
Official title:
Restoration of Bladder Function in Spinal Cord Injury
NCT number | NCT05968352 |
Other study ID # | IRAS 260021 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 18, 2021 |
Est. completion date | May 31, 2025 |
Verified date | July 2023 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this study is to develop improved methods of restoring function to the neurogenic bladder, using electrical stimulation without cutting nerves in patients with spinal cord injury. The investigators will test 5-10 subjects with existing sacral anterior root stimulation (SARS) devices and look at the effects of high frequency (up to 600Hz) compared to the usual low frequency stimulation on bladder function. The investigators are particularly interested in whether it is possible to reproduce a 'functional' dorzal rhizotomy using high frequency stimulation of the S2 efferent nerves
Status | Recruiting |
Enrollment | 10 |
Est. completion date | May 31, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Oxford | Oxford | Oxon |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bladder Pressure | Urodynamics testing - High frequency SARS | 2-3 hours | |
Primary | Rectal Pressure | Urodynamics- High frequency SARS | 2-3 hours | |
Primary | Detrusor Pressure | Urodynamics- High frequency SARS | 2-3 hours | |
Primary | Sphincter Pressure | Urodynamics1- High frequency SARS | 2-3 hours | |
Primary | Volume voided | urodynamics- High frequency SARS | 2-3 hours | |
Primary | Post-void residual volume | Urodynamics- High frequency SARS | 2-3 hours | |
Primary | Voiding Flow Rate | Urodynamics- High frequency SARS | 2-3 hours | |
Secondary | Bladder pressure | Urodynamics - Low frequency SARS | 2-3 hours | |
Secondary | Bladder Capacity | Urodynamics - Low frequency SARS | 2-3 hours | |
Secondary | Reflex incontinence | Urodynamics - Low frequency SARS | 2-3 hours |
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