Plain English Summary
Background and study aims
Spinal cord injury disrupts signals between the brain and the rest of the body, including the signals needed to voluntarily control the bladder and bowels. Following this loss in control people often experience bladder overactivity and incontinence. Currently the main treatment for this is medication, which can have side effects. Neuromodulation (a type of electrical stimulation) is a treatment which can alter nerve activity including that affecting the bladder. The aim of this study is to find out to what extent neuromodulation can reduce unwanted bladder contractions and incontinence when delivered using skin surface electrodes and a portable stimulator in people with spinal cord injury and bladder overactivity over a week in their home environment.
Who can participate?
Spinal cord injured patients aged 18 and over with overactive bladder
What does the study involve?
Participants first record a bladder diary on a provided device for one week. They then visit the clinic to test the portable stimulation system whilst their bladder's behaviour is measured, to ensure they can safely apply it by themselves and to record initial effectiveness. They use the stimulation to manage overactivity at home for one week, then visit the clinic again to re-assess its effect whilst recording bladder behaviour.
What are the possible benefits and risks of participating?
There are no direct benefits of participating. There are a few potential risks including urinary tract infections (infections of the bladder, kidneys and connecting tubes), autonomic dysreflexia (dangerous rise in blood pressure), and skin irritation from the electrodes. These risks are discussed and monitored closely during the study.
Where is the study run from?
Royal National Orthopaedic Hospital (UK)
When is the study starting and how long is it expected to run for?
September 2016 to September 2019
Who is funding the study?
Inspire Foundation (UK)
Who is the main contact?
Mr Sean Doherty
sean.doherty.15@ucl.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Mr Sean Doherty
ORCID ID
Contact details
Royal National Orthopaedic Hospital
Brockley Hill
Stanmore
London
HA7 4LP
United Kingdom
+44 (0)207 909 5605
sean.doherty.15@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
34995
Study information
Scientific title
NEUROMOD: Researching the effect of electrical stimulation on bladder overactivity following spinal cord injury in a home pilot study
Acronym
NEUROMOD
Study hypothesis
The purpose of this pilot study is to determine to what extent neuromodulation can reduce unwanted bladder contractions and incontinence when delivered using skin surface electrodes and a portable stimulator in people with spinal cord injury and bladder overactivity over a week in their home environment.
Ethics approval
Stanmore – London REC, 08/08/2017, ref: 17/LO/1031
Study design
Non-randomised; Interventional; Design type: Treatment, Device, Complementary Therapy
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Home
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
UKCRC code/ Disease: Injuries and Accidents/ Injuries to unspecified part of trunk, limb or body region, Renal and Urogenital/ Other disorders of the genitourinary system
Intervention
Participants will first record a bladder diary on a provided device for one week. They will then visit the clinic to test the portable stimulation system whilst their bladder's behaviour is measured, this will be to ensure they can safely apply it by themselves and to record initial effectiveness. They will use the stimulation to manage overactivity at home for one week, then repeat the visit to the clinic to re-assess its effect whilst recording bladder behaviour.
Intervention type
Device
Phase
Drug names
Primary outcome measures
Bladder overactivity, measured using bladder diary; Timepoint(s): 7 days without intervention, the 7 days with intervention
Secondary outcome measures
Effect of neuromodulation on bladder overactivity, measured using ambulatory urodynamics conducted at the beginning and at the end of the 7-day period where participants are using the stimulation device
Overall trial start date
14/09/2016
Overall trial end date
13/09/2019
Reason abandoned
Eligibility
Participant inclusion criteria
1. Spinal cord injured
2. Aged 18 and over
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: 12; UK Sample Size: 12
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
5. Cardiac pacemaker
6. Active sepsis
7. History of significant Autonomic Dysreflexia
8. Poorly controlled epilepsy. Acceptable where epilepsy is controlled by drugs or there have been no fits experienced for a reasonable period
9. Patients with a cancerous tumour in the area of the electrical stimulation will be excluded as increased local blood flow may increase tumour growth
10. Patients with exposed orthopaedic metal work in the area of electrical stimulation
Recruitment start date
31/08/2017
Recruitment end date
14/09/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal National Orthopaedic Hospital
Brockley Hill
Stanmore
HA7 4LP
United Kingdom
Funders
Funder type
Charity
Funder name
Inspire Foundation
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in relevant peer-reviewed journal, submission of manuscript by September 2019.
IPD sharing statement
The 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
Results - basic reporting
Publication summary