The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
258
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
Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle
The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The least square (LS) mean of the change in weekly number of UI episodes at 6 weeks after the first study treatment was calculated using a mixed model repeated measures (MMRM) analysis.
Time frame: Baseline and Week 6 of DBPC Cycle
Percentage of Subjects With No Episodes of UI at Week 6 of DBPC Cycle
The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The number of subjects with no UI episodes at 6 weeks after the first study treatment was recorded. Percentage of subjects with no episodes of UI (≥100% Improvement) was calculated as: Total number of subjects with no weekly number of UI episodes at Week 6 / Total number of subjects with any number of UI events at Week 6.
Time frame: Baseline and Week 6 of DBPC Cycle
Percentage of Subjects With a UI Response at Improvement Levels ≥30%, ≥50%, and ≥75% at Week 6 of the DBPC Cycle
The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The percentage of subjects showing an improvement of ≥30%, ≥50% and ≥75% was calculated as: Total number of subjects with UI response level \>=30% or \>=50% or \>=75% improvement at Week 6 / Total number of subjects with any UI response at Week 6.
Time frame: Baseline and Week 6 of DBPC Cycle
Median Time Between Treatments
Duration of effect for time between treatments was calculated by: (the date of the first retreatment visit - date of first treatment administration in the DBPC cycle). The median number of days between treatments was determined and subjects with no retreatment were censored at the last visit.
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AbobotulinumtoxinA Placebo 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
Instituto Urológico Buenos Aires
Buenos Aires, Argentina
Centro de Urologia
Buenos Aires, Argentina
Centro Urológico Profesor Bengió
Córdoba, Argentina
Hospital Privado - Centro Médico de Córdoba
Córdoba, Argentina
Instituto Médico Rodriguez Alfici
Godoy Cruz, Argentina
Prince of Wales Hospital (POWH)
Sydney, Australia
Westmead Hospital
Westmead, Australia
Antwerp University hospital
Antwerp, Belgium
Hôpital Erasme
Brussels, Belgium
Ourthe-Amblève
Esneux, Belgium
...and 72 more locations
Time frame: Day of first treatment (baseline) to day of retreatment, up to 2 years
Mean Change From Baseline in Volume Per Void at Week 6 of DBPC Cycle
The volume per void was measured during one 24-hour period of the 7-day bladder diary. The LS mean of the change in volume per void at 6 weeks after the first study treatment was calculated using a MMRM analysis.
Time frame: Baseline and Week 6 of DBPC Cycle
Mean Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 6 of DBPC Cycle
Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the MCC. The LS mean of the change in MCC at 6 weeks after the first study treatment was calculated using an analysis of covariance (ANCOVA).
Time frame: Baseline and Week 6 of DBPC Cycle
Mean Change From Baseline in Maximum Detrusor Pressure (MDP) During Storage at Week 6 of DBPC Cycle
Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the MDP. The LS mean of the change in MDP at 6 weeks after the first study treatment was calculated using an ANCOVA.
Time frame: Baseline and Week 6 of DBPC Cycle
Mean Change From Baseline in Volume at First Involuntary Detrusor Contraction (Vol@1stIDC) at Week 6 of DBPC Cycle
Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the Vol@1stIDC which is the instilled volume when first IDC commences. Subjects who did not exhibit a post-treatment IDC at Week 6 had Vol@1stIDC imputed using the recorded corrected MCC volume at Week 6. The LS mean of the change in Vol@1stIDC at 6 weeks after the first study treatment was calculated using an ANCOVA.
Time frame: Baseline and Week 6 of DBPC Cycle
Percentage of Subjects With No Involuntary Detrusor Contraction (IDCs) During Storage at Week 6 of DBPC Cycle
Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the occurrence of IDCs. The percentage of subjects without IDCs at 6 weeks after the first study treatment was recorded.
Time frame: Baseline and Week 6 of DBPC Cycle