RecruitingNAINTERVENTIONAL

Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury

This study explores how a small, implanted electrical device, called an epidural spinal cord stimulator, can help people with long-term spinal cord injuries improve their bladder and bowel control. Many people with spinal cord injuries struggle with these issues, which can significantly impact daily life. Researchers will recruit volunteers to have this device implanted. They will then work with the research team to find the best settings for the device to help with bladder and bowel function. Over 12 weeks, participants will use the device at home, combined with exercises, with the hope that this new approach could offer a better way to manage these challenges and improve overall quality of life.

At a glance

Status

Recruiting

Phase

Sponsor

University College, London

Enrolment target

Start

14 Oct 2024

Estimated completion

01 Nov 2027

Spinal Cord Injuries Neuromodulation Neurogenic Bladder Neurogenic Bowel Neurogenic Detrusor Overactivity

What is this study about?

This research study is investigating an innovative way to help people who have experienced a spinal cord injury improve their bladder and bowel control. Many individuals living with a spinal cord injury find that these everyday functions become very difficult to manage, which can significantly affect their independence and quality of life. The study wants to see if a small, implanted electrical device, similar to a pacemaker, can make a positive difference.

The device, called an epidural spinal cord stimulator, is designed to send gentle electrical pulses to the nerves around the spinal cord. Researchers hope these pulses can help to restore better communication between the brain and the bladder and bowel. Volunteers taking part will have this device fitted through a small operation. After the implant, the research team will carefully adjust the device settings to find what works best for each individual, aiming to help with issues such as a bladder that becomes overactive or difficulty emptying the bladder or bowels.

Following these adjustments, participants will use the device at home for about three months. They will also learn specific exercises to do alongside the device. The study will monitor how these treatments affect their bladder, bowel, and sexual function, as well as their overall quality of life. The ultimate goal is to understand if this technology can offer a new and effective way to manage these challenging symptoms for people with spinal cord injuries, potentially leading to improved health and well-being.

Key takeaways

Exploring a new way to help with bladder and bowel control after spinal cord injury.
Involves a small, implanted electrical device called an epidural spinal cord stimulator.
Study aims to improve bladder, bowel, and sexual function, and quality of life.
Participants will use the device at home for 12 weeks, combined with exercises.
Close monitoring and support from a medical team throughout the study.

Who may be eligible?

This study is looking for adults aged 18 or older who have had a spinal cord injury above the 'sacral' area at least a year ago. It's important that your spinal cord injury isn't due to a neurodegenerative disease or a completely severed cord. You should also have an overactive bladder that's been confirmed by tests and shown some response to an alternative nerve stimulation technique.

You should be in generally good health, able to understand and speak English, and have enough use of your arms to operate the device. Your current bladder and bowel routines should also be stable and well-managed before you start the study. We won't be able to include anyone who has certain metal implants that would interfere with the device, or anyone who has had specific bladder treatments or surgeries recently, such as Botox injections in the bladder within the past six months.

We also can't include people with ongoing severe urinary infections, women who are pregnant, breastfeeding, or planning to become pregnant without using reliable contraception. If you have other serious medical conditions, mental health issues, or cannot follow study instructions, you would also not be suitable for this research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Did your spinal cord injury happen more than a year ago?
Do you have problems with your bladder, like an overactive bladder?
Are you able to speak and understand English?
Do you have enough hand function to operate a small remote control?
Are you not pregnant or breastfeeding, and using reliable contraception if applicable?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step is a thorough screening to make sure this study is right for you. This involves meeting with different healthcare professionals who will explain everything and make sure you understand the potential benefits and risks. You'll also have tests, including a bladder function assessment.

If eligible, you'll have a small electrical device implanted under your skin, usually in your abdomen or buttocks. After the surgery, you'll attend a few sessions where the research team will fine-tune the device settings to best help with your bladder, bowel, and potentially even leg movement. You'll also learn how to do pelvic floor exercises.

For the next 12 weeks, you'll use the device at home as part of your daily routine combined with your exercises. You'll have regular check-ins and visits to the clinic to review your progress. We'll measure how your bladder, bowel, sexual function, quality of life, and other aspects change before you start, after the 12 weeks, and again at 3 and 6 months after the main intervention period ends. The total duration of active participation and follow-up will be around 9 months.

Potential risks and benefits

Participating in this study might offer several potential benefits, such as improved bladder and bowel control, better sexual function, and an enhanced quality of life. However, as with any medical procedure, there are potential risks, including those associated with surgery to implant the device, infection, or the device not working as expected. These will be fully discussed with you by the medical team so you can make an informed decision. Remember, you can withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal National Orthopaedic Hospital
Verified postcode
Stanmore, United Kingdom· Recruiting

Common questions

What is an epidural spinal cord stimulator?

It's a small, implanted electrical device that sends gentle electrical pulses to nerves around your spinal cord, similar to a pacemaker, to help control various body functions.

Will I feel the electricity from the device?

The goal is for the stimulation to be comfortable. The research team will work with you to find settings that are effective without being unpleasant.

How long will I have the device implanted?

The device is intended to be implanted long-term if it proves beneficial, but this study focuses on a 12-week intervention period followed by check-ups.

Can I still have an MRI with the device?

The specific device used in this study is designed to be compatible with MRI scans, but this will always be checked by your doctors before any scan.

What if the device doesn't help me?

The study aims to understand if the device is effective. If it doesn't help or causes problems, the team will discuss options with you, including potential removal.

How to find out more

Lynsey Duffell, PhD

l.duffell@ucl.ac.uk 0208 385 3787 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.