Condition category
Urological and Genital Diseases
Date applied
26/06/2017
Date assigned
07/07/2017
Last edited
18/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

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

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

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

Government

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 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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/08/2017: Minor edits.