WithdrawnNot Applicable

Restoration of Bladder Function in Spinal Cord Injury

Stopped: Unable to find participants to recruit

United Kingdom0Started 2021-11-18

Plain-language summary

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

Who can participate

Age range

18 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: * 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

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

Bladder Pressure

Timeframe: 2-3 hours

Rectal Pressure

Timeframe: 2-3 hours

Detrusor Pressure

Timeframe: 2-3 hours

Sphincter Pressure

Timeframe: 2-3 hours

Volume voided

Timeframe: 2-3 hours

Post-void residual volume

Timeframe: 2-3 hours

Voiding Flow Rate

Timeframe: 2-3 hours

Trial details

NCT IDNCT05968352

SponsorUniversity of Oxford

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-14

View on ClinicalTrials.gov More Bladder Dysfunction trials

Plain-language summary

Who can participate

Age range

18 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.