Active not recruitingNAINTERVENTIONAL

Brief ES for Recovery of Autonomic Function in CES

This research is investigating a new approach for people who have emergency surgery for a serious back problem called cauda equina syndrome. This condition affects nerves that control how your bladder, bowels, and sexual organs work. Even after surgery, many people still have problems with these functions. The study will gently stimulate the nerves with a special electrical device during surgery, or afterwards if problems continue. The main goal is to see if this electrical stimulation can help these important nerves work better, potentially improving recovery. It's a first step to understand if this treatment could be helpful in the future.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Liverpool

Enrolment target

Start

15 Feb 2024

Estimated completion

15 Sep 2026

Cauda Equina Syndrome

What is this study about?

Cauda equina syndrome is a rare but serious condition that happens when the nerves at the very bottom of your spinal cord get squeezed. These nerves are super important because they control your bladder, bowels, and sexual function. It often happens suddenly due to a slipped disc, and when it does, emergency surgery is usually needed to relieve the pressure on the nerves. Most people affected are between 30 and 49 years old.

Even after successful surgery, many people find they still have difficulties with their bladder, bowels, or sexual function. This can have a big impact on their daily lives. Doctors are looking for ways to improve these outcomes and help these vital nerves recover better. One idea is to use gentle electrical stimulation, a bit like a tiny massage for the nerves, to see if it can encourage them to work more effectively.

This study, called BESCES, is a 'feasibility' study. This means it's an initial step to find out if using this electrical stimulation is safe and practical for people with cauda equina syndrome. The researchers want to see if applying gentle electrical pulses directly to the nerves during or after surgery could help them to heal and transmit messages better. If this smaller study shows promise, it could lead to larger studies in the future to confirm if this treatment is truly effective.

Key takeaways

This study explores a new treatment for cauda equina syndrome.
It uses gentle electrical stimulation to boost nerve recovery.
The aim is to improve bladder, bowel, and sexual function after surgery.
It's a 'first step' study to see if the treatment is safe and promising.
Your standard medical care will not be affected regardless of participation.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older. You also need to have cauda equina syndrome that has caused problems with your bladder, bowels, or sexual function, and be scheduled for emergency surgery for this condition.

However, there are reasons why you might not be able to join. For example, if you already had problems with your bladder, bowels, or sexual function before developing cauda equina syndrome, or if you've had previous back surgery with scar tissue that might make the treatment difficult. Also, if you have certain medical conditions like a pacemaker, uncontrolled diabetes, or particular infections, you might not be suitable.

Quick self-check

Are you 18 years old or older?
Do you have cauda equina syndrome with bladder, bowel, or sexual problems?
Are you scheduled for emergency surgery for this condition?
Do you have any existing medical conditions like a pacemaker or uncontrolled diabetes?
Have you had previous spinal surgery that might cause issues?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

As this is a feasibility study, the details of participation are being assessed. However, for those who take part, the key step involves receiving brief electrical stimulation either during your decompression surgery or, if symptoms persist, after surgery to help with bladder control. The study will mainly focus on checking if applying this electrical stimulation is safe and possible to do, and if it helps your nerves recover. The total duration of your participation in terms of assessments and follow-up will be outlined by the study team, but it's important to note that the immediate stimulation during or after surgery is a brief intervention.

Potential risks and benefits

Potential benefits of taking part could include the advanced treatment with electrical stimulation, which might help improve your recovery and function in ways that standard surgery alone may not. However, this is still a new approach, so the benefits are not yet guaranteed. Potential risks might involve discomfort from the electrical stimulation, or complications linked to the surgical procedure itself, though the electrical device used is already approved for other uses. Your participation is always voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

The Walton Centre NHS Foundation Trust
Liverpool, United Kingdom

Common questions

What is cauda equina syndrome?

It's a serious condition where nerves controlling your bladder, bowels, and sexual function get squeezed, usually needing emergency surgery.

What is 'brief electrical stimulation' (ES)?

It's a gentle electrical pulse given to the nerves, similar to a tiny massage, to help them work better.

Will I feel the electrical stimulation?

The stimulation is delivered gently, often during surgery while you are anaesthetised, or at a level that aims to be comfortable if used afterwards.

What does a 'feasibility study' mean?

It's an early study to see if a new treatment is safe, practical, and shows enough promise to be studied more extensively in the future.

Will this help my bladder and bowel problems?

The study hopes to see if the stimulation can improve these functions, but it's an early investigation, so full recovery isn't guaranteed.