Non-invasive neuromodulation for bladder suppression following spinal cord injury

• Register: ISRCTN
• Last refreshed on: 14 January 2019
• Main ID: ISRCTN17182264
• Date of registration: 21/08/2017
• Prospective Registration: Yes
• Primary sponsor: Royal National Orthopaedic Hospital NHS Trust
• Public title: Non-invasive neuromodulation for bladder suppression following spinal cord injury
• Scientific title: NEUROMOD: Researching the effect of electrical stimulation on bladder overactivity following spinal cord injury in a home pilot study
• Date of first enrolment: 31/08/2017
• Target sample size: 12
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN17182264
• Study type: Interventional
• Study design: Non-randomised; Interventional; Design type: Treatment, Device, Complementary Therapy (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: Sean Doherty

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

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
Urological and Genital Diseases

Intervention(s)

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.

Primary Outcome(s)

Bladder overactivity, measured using bladder diary; Timepoint(s): 7 days without intervention, the 7 days with intervention

Secondary Outcome(s)

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

Secondary ID(s)

34995

Source(s) of Monetary Support

Inspire Foundation

Ethics review

Status:
Approval date:
Contact:

Stanmore – London REC, 08/08/2017, ref: 17/LO/1031

Results

• Results available: Yes
• Date Completed: 01/09/2020