on-invasive neuromodulation for bladder suppression following spinal cord injury
- Conditions
- KCRC code/ Disease: Injuries and Accidents/ Injuries to unspecified part of trunk, limb or body region, Renal and Urogenital/ Other disorders of the genitourinary systemUrological and Genital Diseases
- Registration Number
- ISRCTN17182264
- Lead Sponsor
- Royal National Orthopaedic Hospital NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 12
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bladder overactivity, measured using bladder diary; Timepoint(s): 7 days without intervention, the 7 days with intervention
- Secondary Outcome Measures
Name Time Method 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