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Botulinum Toxin A for NDO in Chronic SCI
NCT01682603Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2012
- Primary completion
- Dec 2013
- Countries
- 1
- Sponsor
- Buddhist Tzu Chi General Hospital
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- neurogenic detrusor overactivity (NDO)
01
Overview
Phase 2, open-label, single-arm trial of botulinum toxin type A in neurogenic detrusor overactivity (NDO), sponsored by Buddhist Tzu Chi General Hospital. Primary endpoints: Urinary Distress Inventory-6 at 24 months, Incontinence Impact Questionnaire-7 at 24 months and 2 more. Started Sep 2012; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Botulinum toxin A
Single arm receiving Botox injections
03
Who it enrols
Adult patients (>=19 years) with chronic suprasacral spinal cord injury (>1 year) and proven neurogenic detrusor overactivity. Patients must void by reflex, abdominal stimulation, or CIC, and have a baseline GFR < 80 mL/min. Patients with indwelling catheters, UTIs, or intrinsic sphincteric deficiency are excluded.
04
Endpoints
Primary
Urinary Distress Inventory-6
Incontinence Impact Questionnaire-7
Quality of Life Index
Glomerular Filtration Rate
Secondary
Cystometric Bladder Capacity
Bladder Compliance
Maximum Flow Rate
Void Volume
Detrusor Pressure
Postvoid Residual Volume
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