The purpose of this study was to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents.
The NDO often occurs in patients with spina bifida or other spinal cord damage where the bladder muscle contracts more than normal during filling. These patients often have an inability to void, so that catheterization is required to empty the bladder. The medicine being tested in this study is called solifenacin succinate. Solifenacin tablets are given to adults for the treatment of overactive bladder. A new liquid suspension has been developed to treat children and adolescents in this and other studies. The efficacy and safety of the solifenacin suspension was investigated. The take-up and length of time that the solifenacin suspension stays in the body was also investigated during this study. Effectiveness was measured by urodynamics (the filling and emptying of the bladder) and the urine volumes during catheterization together with the diary responses relating to the number of incontinence episodes or incontinence free days. Safety assessments included analysis of the blood and urine, review of the electrocardiogram (ECG), ultrasound of the kidney, simple memory and understanding tests (cognitive function) and the ability to see near and far objects (visual accommodation).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Oral suspension administered once a day via syringe.
Site US1008
Tarrytown, New York, United States
Site US1010
Cincinnati, Ohio, United States
Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)
During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed.
Time frame: Baseline and Week 24
Change From Baseline to Last Possible Titration Step in Maximum Cystometric Capacity
During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed. Based on study requirements, the last possible titration step was Week 9 for participants enrolled under versions 1.0 and 1.1 and Week 12 under later versions.
Time frame: Baseline, Week 9 or Week 12
Change From Baseline in Bladder Compliance
Bladder compliance gives an indication of the elasticity of the bladder wall and was calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder.
Time frame: Baseline and Week 24
Change From Baseline in Bladder Volume (mL) Until First Detrusor Contraction > 15 cmH2O as a Percentage of Expected Bladder Capacity (EBC)
Change from baseline in the bladder volume was calculated using urodyanamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. If no detrusor contraction of at least 15 cmH2O occurs, the bladder volume was imputed with MCC.
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Site BE3201
Ghent, Belgium
Site BR5505
São José do Rio Preto, São Paulo, Brazil
Site BR5507
Campinas, Brazil
Site BR5504
Campinas, Brazil
Site BR5506
Curitiba, Brazil
Site BR5503
Porto Alegre, Brazil
Site DK4501
Aarhus, Denmark
Site HU3602
Miskolc, Hungary
...and 11 more locations
Time frame: Baseline and Week 24
Change From Baseline in Bladder Volume at 30 cmH2O Detrusor Pressure
Bladder volumes at 30 cm H2O detrusor pressure was calculated using the urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the participants experiences pain or discomfort or 135% of expected bladder capacity for age has been reached.
Time frame: Baseline and Week 24
Change From Baseline in Bladder Volume at 40 cmH2O Detrusor Pressure
Bladder volumes at 40 cm H2O detrusor pressure were calculated using urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached.
Time frame: Baseline and Week 24
Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until End of Bladder Filling
Change from baseline in number of overactive detrusor contractions until end of bladder filling was measured by urodynamic testing. If leakage occurred, the "Detrusor pressure at leakage" was recorded otherwise the volume of fluid instilled into the bladder was recorded.
Time frame: Baseline to Week 24
Change From Baseline in Detrusor Pressure at the End of Bladder Filling
The bladder was filled until voiding/leakage began or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. Pressure was recorded for an extra 5 minutes after leakage began or the end of bladder-filling, whichever is sooner.
Time frame: Baseline to Week 24
Change From Baseline in Average Catheterized Volume Per Catheterization
The average catheterized volume per catheterization was calculated using all available (non-zero) catheterized volumes recorded over both of the 2 measuring days in the diary, whether or not these 2 days are concurrent.
Time frame: Baseline to Week 24
Change From Baseline in Maximum Catheterized Volume
The maximum catheterized volume per day was calculated using all available (non-zero) catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days were concurrent. The maximum value was calculated separately for each measuring day and the mean of these two values was used.
Time frame: Baseline to Week 24
Change From Baseline in Average First Morning Catheterized Volume
The average first morning catheterized volume was calculated as the average of the available first morning catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days are concurrent.
Time frame: Baseline to Week 24
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
The mean of the number of incontinence episodes per 24h was calculated as the mean over the valid diary days in the 7-day diary.
Time frame: Baseline to Week 24
Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days
The number of incontinence-free days was calculated from the 7-day micturition diary.
Time frame: Baseline to Week 24
Change From Baseline in Number of Dry (Incontinence-Free) Nights Per 7 Days
The number of incontinence-free nights was calculated from the 7-day micturition diary.
Time frame: Baseline to Week 24
Change From Baseline in Quality of Life [QoL] (PinQ Questionnaire Score)
Pediatric Incontinence Questionnaire (PinQ) is a 20-item questionnaire addressing quality of life for participants with bladder disorders. Each question was answered on a scale from 0 (no, never) to 4 (all the time). The total score ranged from 0 to 80, with higher scores indicated more impact on the quality of life.
Time frame: Baseline to Week 24
Number of Participants With Adverse Events
A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the first dose of study medication on Day 1. All adverse events collected within 7 days after taking the last dose of study drug were counted as a TEAE.
Time frame: Baseline to End of Study Visit (Week 52)