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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
227
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
Mean Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 6 of DBPC Cycle
All 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) at Week 6 of DBPC Cycle
All 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
All 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
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AbobotulinumtoxinA Placebo 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
UAB School of Medicine Spain Rehabilitation Center (SRC)
Birmingham, Alabama, United States
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona, United States
Atlantic Urology Medical Group
Long Beach, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Women's Health Specialty Care
Farmington, Connecticut, United States
Gousse Urology - The Bladder Heath and Reconstructive Urology Institute
Miramar, Florida, United States
The Iowa Clinic, PC
West Des Moines, Iowa, United States
Chesapeake Urology Associates, PA
Owings Mills, Maryland, United States
...and 71 more locations
Number 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 and the percentage of subjects was also calculated from the total number of subjects with any number of UI events at Week 6.
Time frame: Baseline and Week 6 of DBPC Cycle
Number of Subjects With No IDCs During Storage at Week 6 of DBPC Cycle
All subjects had a standardised urodynamic filling cystometry assessment at baseline (screening) and again at Week 6 to determine the occurrence of IDCs. The number of subjects without IDCs at 6 weeks after the first study treatment was recorded and the percentage of subjects was also calculated from the total number of subjects with data available for analysis at Week 6.
Time frame: Baseline and Week 6 of DBPC Cycle
Mean Change From Baseline in Incontinence Quality of Life (I-QoL) Questionnaire Total Summary Score at Week 6 of DBPC Cycle
The I-QoL questionnaire is a validated, disease-specific questionnaire designed to measure the effect of UI on subjects' QoL. It consists of 22 items in 3 domains (avoidance and limiting behaviour, psychosocial impact and social embarrassment). Subjects used a 5-point response scale for each of the 22 items with values ranging from 1 (extremely) to 5 (not at all). The total summary score was transformed to a 100 point scale ranging from 0 to 100, with higher scores indicating a better QoL. The LS mean of the change in the I-QoL total summary score at 6 weeks after the first study treatment was calculated using a MMRM analysis.
Time frame: Baseline and Week 6 of DBPC Cycle
Number 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 number of baseline UI episodes was compared with the number of UI episodes at Week 6 to determine the level of response each subject reached, i.e. a decrease of ≥30%, ≥50% or ≥75% . The number of subjects showing an improvement of ≥30%, ≥50% and ≥75% were recorded and the percentage of subjects was also calculated from the total number of subjects with any number of UI events at Week 6.
Time frame: Baseline and Week 6 of DBPC Cycle
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
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 based on the Kaplan-Meier method. Subjects with no retreatment were censored at the last visit.
Time frame: Day of first treatment (baseline) and day of retreatment, up to 2 years