ImPRESS trial

Background Information

In this trial, the main aim is to investigate whether eSCS can be used to improve bladder and bowel function in people living with SCI. We will use eSCS to target specific nerves that control the bladder and bowel, including:

• The nerves that cause them to relax (to suppress overactivity)
• The nerves that cause them to contract (to initiate voiding)
• The nerves that control the muscles in the pelvic floor (to facilitate control of bladder and bowel functions)

Why is this research important?

Research focused on bladder, bowel and sexual function has been highlighted as a priority among the SCI population, however research in this field remains particularly limited.

After a SCI, signals between the brain and the pelvic organs (bladder and bowel) are disrupted. As a result, the bladder often becomes overactive which can lead to frequent trips to the toilet, regular incontinence episodes and a decreased quality-of-life.

Additionally, constipation, faecal incontinence, and severe bowel dysfunction commonly occur. Bowel management programmes involving digital rectal stimulation or bowel irrigation systems can be socially inconvenient, time consuming and exhausting.

Both bladder and bowel dysfunction can have life-threatening complications and a considerable impact on health-related quality of life.

Research studies investigating eSCS for physical rehabilitation (sit to stand, walking) after SCI have reported important improvements in bladder and bowel function. In these studies, the eSCS was not programmed to target bladder or bowel function, therefore the potential benefits could be substantially more than what is currently reported.

What is epidural spinal cord stimulation?

Epidural spinal cord stimulation (eSCS) has been used to treat chronic pain for over 50 years. Electrode leads or paddles are implanted in the epidural space of the spinal cord. A small device is attached to the electrode cable, and is also implanted, most commonly in the upper buttock area. 

eSCS delivers small electrical pulses to specific nerves where they join the spinal cord. This stimulation can alter the signals traveling from the spinal cord to the body and can be programmed to directly target a specific area.

Epidural stimulators are considered safe; thousands of people have received them for treating chronic leg and back pain. They are not routinely applied in the SCI population, however there are >30 people living with chronic SCI who have received SCS implants globally.

More information about The RNOH Neuromodulation service, including Spinal Cord Stimulators FAQ.

What to expect during the ImPRESS trial

The investigators will recruit up to 20 people with chronic SCI and confirmed neurogenic detrusor overactivity via a bladder test (urodynamics). Following screening and review of suitability for the eSCS procedure, participants will be invited to have the eSCS implanted.

The eSCS will be programmed to target bladder and bowel function and participants.

Participants will use these programmes as part of their daily routine at home for 12 weeks, in combination with pelvic floor muscle training.

Measurements assessing bladder, bowel, sexual function, quality of life, muscle function and spasticity will be captured prior to and following the 12-week intervention, and at 3 and 6 month follow up.

To register your interest for the ImPRESS trial, please complete the following survey form - CLICK HERE

Note: To be eligible to take part, potential participants must meet the following inclusion and exclusion criteria:

Inclusion Criteria:

• Spinal Cord Injury (supra-sacral)

• American Spinal Injury Association (AISA) impairment scale A-D
• 18 years of age or older
• SCI sustained >12 months ago;
• Neurogenic detrusor overactivity (NDO) confirmed on urodynamics *
• Responsive to dorsal genital nerve stimulation *
• Willing and able to provide informed consent
• Stable medical, physical and psychological condition as considered by the investigators *
• Able to understand and interact with the study team in English
• Sufficient upper limb function to operate the device
• Suitably optimised bladder and bowel routine *

Exclusion Criteria:

• Transected cord or SCI related to a neurodegenerative disease
• Any device or metal work in situ that would exclude the patient from having eSCS implanted
• Intra-detrusor botulinum toxin injections within the last 6 months
• Previous surgical intervention on bladder sphincters
• Any diseases and conditions that would exclude the patient from eSCS and/or surgery, for example, degenerative spinal pathology, syrinx and/or tumor*
• Recurrent urinary tract infection refractory to antibiotics
• Women who are pregnant or intending to become pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding, or lack of safe contraception for women of childbearing capacity
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the participant
• Participation in another study with investigational drug within the 30 days preceding and during the present study
• Enrolment of the investigator, his/her family members, employees, and other dependent persons

*This will be assessed during the screening process

Meet the Team

We are a multidisciplinary team, led by Dr Lynsey Duffell, Associate Professor and Clinical Scientist at UCL, and Mr David Baxter, Consultant Neurosurgeon and Spinal Surgeon at The London Spinal Cord Injury Centre, RNOH.

Dr. Lynsey Duffell ​​​​​is a Clinical Scientist and an Associate Professor within the Department of Medical Physics & Biomedical Engineering at UCL. Lynsey’s research aims to improve health and quality of life for people living with spinal cord injury, with a particular focus on neuromodulation combined with activity-based therapy for neuroplastic recovery.

Contribution to ImPRESS project: Dr Duffell is Chief Investigator on the ImPRESS trial. She has oversight of all trial activities. Dr Duffell will contribute to recruitment and screening, mapping sessions, determining stimulation parameters and device programming.

Mr David Baxter is a Consultant Neurosurgeon at Whittington Hospital and Honorary Associate Professor within the Research Department of Orthopedics and Musculoskeletal Science at UCL. David is passionate about optimising function after spinal cord injury and exploring the potential of computer vision in surgery.

Contribution to ImPRESS project: Mr Baxter is Principal Investigator on the ImPRESS trial. He has medical oversight of all trial activities and will be part of the neurosurgical team conducting the surgical procedures.

Co-investigators:

Mr John Afolayan is a Consultant Orthopaedic and Spinal Surgeon at the RNOH. He has extensive training in orthopaedic and neurosurgical spinal surgery. His practice spans all aspects of spinal surgery with a particular interest in the surgical management of spinal tumours and complex spinal conditions.

Contribution to ImPRESS project: Mr Afolayan is a member of the investigating and surgical team. He is involved in study recruitment, subject screening, study visits and implant insertion.

Mr Manish Desai​​​​​ is a Consultant in Spinal Injury and Trauma Rehabilitation at the LSCIC, RNOH. His specialist clinical interests are management of complex spasticity, pressure sores, MSK conditions and specialist rehabilitation of patients with Spinal Cord Dysfunction due to Polytrauma, Tumours, and Cauda Equina Compression (Syndrome).

Contribution to ImPRESS project: Mr Desai will contribute towards recruitment and screening, and provide medical support throughout the trial.

Dr Sarah Knight is a Consultant Clinical Scientist at the London Spinal Cord Injury Centre (LSCIC), RNOH. She has a dual clinical and research role. She has over 25 years of experience in clinically applied research in neuro-urology and spinal cord injury. She has a special interest in the application of neuromodulation to restore bladder and bowel function after spinal cord injury.

Contribution to ImPRESS project: Interim Principal Investigator during study set up, and initial recruitment. Dr Knight will contribute to the study recruitment, subject screening, urodynamics and outcome measure visits.  

Dr Sean Doherty is a Research Fellow at University College London with expertise in implantable and wearable neuromodulation devices, his research focuses on restoring pelvic function for individuals with spinal cord injuries. Dr. Doherty holds a PhD in Neural Engineering and a master's degree in medical engineering. He has worked at UCL and the London Spinal Cord Injury Center on developing novel techniques to restore bladder and bowel function since 2015. Sean has lived experience of spinal cord injury, having had a SCI over 15 years ago.

Contribution to ImPRESS project: Sean contributes to study design, device programming, data collection and data analysis.

Dr Hannah Houliston is a post-doc Research Physiotherapist at the LSCIC, RNOH, and Honorary Research Fellow at UCL. She recently conducted a research project investigating transcutaneous spinal cord stimulation and pelvic floor physiotherapy in individuals with spinal cord injury at the LSCIC. Alongside her research role, she works clinically as a Specialist Physiotherapist at The National Hospital for Neurology and Neurosurgery.  

Contribution to ImPRESS project: Hannah is responsible for study set up, recruitment and screening, study related assessments and visits, including pelvic floor assessment and training, data collection and data analysis.

Ms Natalia Vasquez is a Specialist Pelvic Health Physiotherapist at the LSCIC, RNOH. Natalia has conducted several research studies investigating different techniques to promote neuroplasticity for improving bladder function in SCI. The findings of her research were translated into the development of a pelvic physiotherapy clinic for the management of bladder, bowel and sexual dysfunction in SCI at the LSCIC. Natalia has over 15 years of experience in neurology and pelvic health and is passionate about improving patients' quality of life in this area.

Contribution to ImPRESS project: Natalia will conduct pelvic floor examinations and training, conduct outcome measurements including urodynamics, and anorectal manometry.

Sister Evangeline Martinez is a Research Nurse and Research Assistant at the LSCIC and UCL.  She has been involved with research in neuro-urology and spinal cord injury since 2021.  She is currently undertaking a MSc in Clinical Research Delivery at King’s College London. Prior to research, her clinical experience spans 30 years undertaking different clinical roles such as staff nurse, theatre practitioner, ward sister and clinical nurse specialist mostly in the specialism of spinal cord injury. 

Contribution to ImPRESS project: Sister Evangeline will conduct recruitment and screening, study related assessments and visits, including urodynamics, outcome measure assessments, mapping sessions, and data collection.

Key Collaborators:

Dr Tacson Fernandez, Consultant Anesthetist, Neuromodulation Service, RNOH

Prof. Anton Emmanuel, Consultant Gastroenterologist, RNOH/UCLH

Mr Richard Nobrega, Consultant Urologist, RNOH/UCLH

Prof. Jalesh Panicker, Consultant Neurologist, specialist in Uro-neurology, UCLH

Prof Ronaldo Ichiyama, University of Leeds

Dr Dagmar Alber, UCL Microbiome Team

Dr Mona Bajaj-Elliott​​​​​​, UCL Microbiome Team

This research is funded by:

• Brain Research UK
  • Electrical stimulation to improve bladder control after spinal cord injury – Neurological research (brainresearchuk.org.uk)
• The International Spinal Research Trust, Injured Jockey’s Fund
  • ImPRESS: Improving Pelvic Rehabilitation using Epidural Stimulation after SCI - Spinal Research (spinal-research.org)

Epidural SCS Devices:

The SCS devices are donated by Nevro