Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1
Condition: Urinary Incontinence; Overactive Bladder
MeSH terms: Multiple Sclerosis; Spinal Cord Injuries; Urinary Incontinence; Enuresis; Urinary Bladder, Overactive
Intervention: Botulinum toxin type A; Botulinum toxin type A; Placebo; Placebo
Intervention description: 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points; 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points; AbobotulinumtoxinA Placebo 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points; AbobotulinumtoxinA Placebo 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
Intervention MeSH terms: Hemagglutinins; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 227.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to provide confirmatory evidence of the safety and efficacy of
      two Dysport® (AbobotulinumtoxinA) doses (600 units [U] and 800 U), compared to placebo in
      reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor
      overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  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.

          -  Routinely performing Clean Intermittent Catheterization (CIC) to ensure adequate
             bladder emptying.

          -  An average of at least two episodes per day of Urinary Incontinence recorded on the
             screening bladder diary.

        Key Exclusion Criteria:

          -  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.