Non-invasive neuromodulation for bladder suppression following spinal cord injury
| ISRCTN | ISRCTN17182264 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17182264 |
| Secondary identifying numbers | 34995 |
- Submission date
- 21/08/2017
- Registration date
- 21/08/2017
- Last edited
- 12/12/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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 2020
Who is funding the study?
Inspire Foundation (UK)
Who is the main contact?
Mr Sean Doherty
sean.doherty.15@ucl.ac.uk
Contact information
Public
Royal National Orthopaedic Hospital
Brockley Hill
Stanmore
London
HA7 4LP
United Kingdom
| Phone | +44 (0)207 909 5605 |
|---|---|
| sean.doherty.15@ucl.ac.uk |
Study information
| Study design | Non-randomised; Interventional; Design type: Treatment, Device, Complementary Therapy |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | NEUROMOD: Researching the effect of electrical stimulation on bladder overactivity following spinal cord injury in a home pilot study |
| Study acronym | NEUROMOD |
| Study objectives | 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(s) | Stanmore – London REC, 08/08/2017, ref: 17/LO/1031 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 14/09/2016 |
| Completion date | 01/09/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 12; UK Sample Size: 12 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 31/08/2017 |
| Date of final enrolment | 30/09/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Stanmore
HA7 4LP
United Kingdom
Sponsor information
Hospital/treatment centre
Brockley Hill
Stanmore
London
HA7 4LP
England
United Kingdom
"ROR" |
https://ror.org/03dx46b94 |
|---|
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/09/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in relevant peer-reviewed journal, submission of manuscript by September 2020. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
12/12/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 14/09/2018 to 30/09/2019.
2. The overall trial end date was changed from 13/09/2019 to 01/09/2020.
3. The intention to publish date was changed from 01/09/2019 to 01/09/2020.
23/08/2017: Internal edits.
