Clareo Health | Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1
Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1
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Keep this study
Lead
Ipsen
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Urinary Incontinence for at least 3 months prior to Screening as a result of Neurogenic Detrusor Overactivity due to Spinal Cord Injury or Multiple Sclerosis.
Subjects with Spinal Cord Injury must have a stable neurological injury at T1 level or below which occurred at least 6 months prior to Screening.
Subjects with Multiple Sclerosis must be clinically stable in the investigator's opinion, with no exacerbation (relapse) of MS for at least 3 months prior to Screening.
Subjects must have had an inadequate response after at least 4 weeks of oral medications used in the treatment of NDO (e.g. anticholinergics, beta-3 agonists) and/or have intolerable side-effects.
An average of at least two episodes per day of Urinary Incontinence recorded on the screening bladder diary.
You may not be if
Any current condition (other than NDO) that may impact on bladder function.
Previous or current, tumour or malignancy affecting the spinal column or spinal cord, or any other unstable cause of SCI.
Any condition that will prevent cystoscopic treatment administration or CIC usage, e.g. urethral strictures.
Current indwelling bladder catheter, or removal of indwelling bladder catheter less than 4 weeks prior to Screening.
BTX-A treatment within 9 months prior to Screening for any urological condition (e.g. detrusor or urethral sphincter treatments).
Any neuromodulation/electrostimulation usage for urinary symptoms/incontinence within 4 weeks prior to Screening. Any implanted neuromodulation device must be switched off at least 4 weeks prior to Screening.
