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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 11 September 2017
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: Completed
URL:  http://isrctn.com/ISRCTN17182264
Study type:  Interventional
Study design:  Non-randomised; Interventional; Design type: Treatment, Device, Complementary Therapy (Treatment)  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Sean    Doherty
Address:  Royal National Orthopaedic Hospital Brockley Hill Stanmore HA7 4LP London United Kingdom
Telephone: +44 (0)207 909 5605
Email: sean.doherty.15@ucl.ac.uk
Affiliation: 
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
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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