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
Conditions
Interventions
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,
Sponsors
Royal National Orthopaedic Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bladder overactivity, measured using bladder diary; Timepoint(s): 7 days without intervention, the 7 days with intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Contacts
Public ContactSean Doherty
Outcome results
None listed