Plain English Summary
Background and study aims
Following spinal cord injury, signals to between the brain and bladder are disrupted. This means that the voluntary control of the bladder stops functioning properly. Often as a result of this overactivity of the bladder muscle develops, leading to frequent contractions at low volumes. This may result in leaking urine and/or damage to the bladder and kidneys. Neuromodulation (a type of electrical stimulation) is a treatment which can alter nerve activity including those affecting the bladder. It is not currently known which nerve is the most effective to stimulate for improving continence in individuals with spinal cord injuries. The aim of pilot study is to determine to what extent neuromodulation can reduce unwanted bladder contractions and incontinence when delivered using skin surface electrodes over 4 different nerves in the body. The findings will inform the development of a new treatment method for bladder overactivity for people with spinal cord injuries.
Who can participate?
Adults aged 18 to 70 who have sustained a spinal cord injury more than 6 months ago and have subsequently developed bladder overactivity
What does the study involve?
Participation involves five separate sessions of urodynamics, during which a different nerve is stimulated in each session using surface ’sticker’ electrodes. The stimulation involves electrodes on the genital nerve (penis or clitoris), the ankle, the lower back and the sacrum (triangular bone in the lower back), each tested separately. Before each session the participant may be asked to stop taking their current bladder suppressing medication for five days. Urodynamics involves catheters being inserted into the bladder through the urethra and into the rectum, these fill the bladder with sterile water and measure pressures to determine overactivity. The participants have their bladders filled without stimulation and with stimulation, to assess each nerve's effect on bladder activity. Each session takes around two hours and takes place on a separate day.
What are the possible benefits and risks of participating?
There are no notable benefits with participating. There are a few potential risks including urinary tract infections (infections of the bladder, kidneys and connecting tubes), incontinence (unintentionally passing urine), autonomic dysreflexia (dangerous rise in blood pressure), and skin irritation from the electrodes.
Where is the study run from?
This study is being run by the Royal National Orthopaedic Hospital in Stanmore, London in collaboration with University College London. All investigations will take place in the London Spinal Cord Injuries Centre's urodynamics clinic.
When is the study starting and how long is it expected to run for?
September 2015 to September 2019
Who is funding the study?
The INSPIRE Foundation (UK)
Who is the main contact?
1. Mr Sean Doherty (public)
sean.doherty.15@ucl.ac.uk
2. Dr Sarah Knight (scientific)
sarah.knight@rnoh.nhs.uk
Trial website
Contact information
Type
Public
Primary contact
Mr Sean Doherty
ORCID ID
Contact details
Royal National Orthopaedic Hospital
Brockley Hill
Stanmore
London
HA74LP
United Kingdom
+44 (0)207 909 5605
sean.doherty.15@ucl.ac.uk
Type
Scientific
Additional contact
Dr Sarah Knight
ORCID ID
http://orcid.org/0000-0002-5994-2081
Contact details
Royal National Orthopaedic Hospital
Brockley Hill
Stanmore
London
HA74LP
United Kingdom
+44 (0)207 909 5605
Sarah.knight@rnoh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
20733
Study information
Scientific title
Investigating transcutaneous neuromodulation for reduction of bladder, bowel and spasticity in spinal cord injury as an alternative to pharmacological treatment: towards wearable devices
Acronym
Study hypothesis
The aim of this research is to investigate the acute effects of neuromodulation (electrical stimulation of neural pathways to modify their activity) on bladder spasticity with respect to stimulation site, to determine the optimum anatomical site for reduction of bladder overactivity in patients with Spinal Cord Injury (SCI).
Ethics approval
Queen Square REC London, 28/01/2016, ref: 16/LO/0164
Study design
Randomised; Interventional; Design type: Treatment, Device
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Specialty: Renal disorders, Primary sub-specialty: Renal disorders
Intervention
To ascertain the most effective transcutaneous stimulation site the efficacy of neuromodulation using surface electrodes is investigated at distinct anatomical sites: Dorsal Genital Nerve, Posterior Tibial Nerve, Sacral Roots and Spinal Cord.
The investigation involves the monitoring of the bladder activity and pressures during standard urodynamics performed both with and without stimulation in up to 20 participants. First a standard cystometrogram (CMG) is performed to measure bladder capacity and activity before any stimulation takes place.
Electrodes are then be placed on the skin over one of the four sites (a different one each session) and the stimulation intensity is set. Next further CMG are performed, during which stimulation is started each time the pressure in the bladder rises as a result of unwanted contractions. The CMG’s involves catheters being inserted into the bladder through the urethra and into the rectum, these fill the bladder with sterile water and measure pressures to determine overactivity.
The investigation takes place over five sessions on separate days, each takes up to two hours and each assesses one stimulation site.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Bladder overactivity is measured using standard urodynamics to measure bladder pressures and volumes without stimulation present (control), then with stimulation over one of four sites (experimental).
Secondary outcome measures
No secondary outcome measures
Overall trial start date
14/09/2015
Overall trial end date
13/09/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Spinal Cord Injured
2. Aged 18-70
3. Male or Female
4. Injury sustained >6 months ago
5. Urodynamically proven Neurogenic Detrusor Overactivity
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 20; UK Sample Size: 20
Total final enrolment
10
Participant exclusion criteria
1. Recipient of intra-detrusor botulinum toxin injections within the last 6 months
2. Previous surgical intervention on bladder/sphincters
3. Showing positive leucocytes and nitrites on urinalysis on the day of investigation
4. Pregnancy
Recruitment start date
04/04/2016
Recruitment end date
14/09/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal National Orthopaedic Hospital (RNOH)
Brockley Hill
Stanmore
London
HA7 4LP
United Kingdom
Funders
Funder type
Government
Funder name
Inspire Foundation
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a relevant peer reviewed journal by September 2019.
IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/09/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2019 results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6951414/ (added 01/10/2020)