Condition category
Urological and Genital Diseases
Date applied
21/08/2017
Date assigned
21/08/2017
Last edited
23/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Sponsor information

Organisation

Royal National Orthopaedic Hospital NHS Trust

Sponsor details

Brockley Hill
Stanmore
London
HA7 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes

23/08/2017: Internal edits.