Neurogenic Detrusor Overactivity, Pediatric
Conditions
Keywords
Solifenacin succinate suspension, Efficacy, Safety
Brief summary
The purpose of this study was to evaluate long term efficacy and safety of treatment with solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after multiple dose administration.
Detailed description
In some children with a severe form of spina bifida (which is the consequence of a spinal cord defect), the bladder muscle (detrusor) contracts strongly and without warning (also known as neurogenic detrusor overactivity) and the urethra (the passage connecting the bladder with outside) does not relax. Though these children cannot void, urine leakage can happen when the overactive contractions are strong, and/or the pressure in the bladder is so high that it overcomes the closed urethra (overflow at high filling bladder pressure). This high bladder pressure puts these children at risk for kidney damage and can decrease the quality of the bladder. Therapy was aimed to decrease the high filling bladder pressure and the overactive detrusor contractions.
Interventions
DRUGSolifenacin succinate
Oral suspension
Sponsors
Astellas Pharma Europe B.V.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 4 Years
Healthy volunteers
No
Inclusion criteria
* Myelomeningocoele * Documented diagnosis of NDO, confirmed by urodynamics * DSD (detrusor sphincter dyssynergia) * Practicing clean intermittent catheterization (CIC)
Exclusion criteria
* Know genitourinary condition (other than NDO) that may cause incontinence * Bladder augmentation surgery * Current faecal impaction * Electro-stimulation therapy within 2 weeks prior to visit * Subjects with the following gastro-intestinal problems: partial or complete obstructions, decreased motility like paralytic ileus, subjects at risk of gastric retention * Reflux grade 3 to 5 * Current urinary tract infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC) | Baseline and Week 24 | MCC was the volume instilled into the bladder prior to leakage or end of bladder-filling (whichever was reached first), as assessed by urodynamics (procedure: the bladder was to be filled until voiding/leakage began, or until it was stopped because either the participant experienced pain or discomfort or 135% of expected bladder capacity \[EBC\] was reached for participants ≥ 2 years or of maximum catheterized volume \[MCV\] for participants aged 6 months to \< 2 years; the participants' bladder was emptied via catheterization). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance | Baseline and Weeks 3, 6, 9, 12, 24, 52 | Bladder compliance gives an indication of the elasticity of the bladder wall. Bladder compliance was calculated by dividing the change in volume during the filling of the bladder by the change in detrusor pressure during that change in bladder volume using urodynamic assessments. The values for bladder volume and detrusor pressure at the beginning and end of filling were taken and used. |
| Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling | Baseline and Weeks 3, 6, 9, 12, 24, 52 | Detrusor pressure was expressed as bladder pressure minus intra-abdominal pressure as assessed by urodynamics. |
| Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling | Baseline and Weeks 3, 6, 9, 12, 24, 52 | Detrusor pressure was expressed as bladder pressure minus intra-abdominal pressure as assessed by urodynamics. |
| Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling | Baseline and Weeks 3, 6, 9, 12, 24, 52 | Catheterized volume was measured when the bladder was emptied via catheterization 5 minutes after the end of bladder-filling. |
| Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O) | Baseline and Weeks 3, 6, 9, 12, 24, 52 | Bladder volume as assessed by urodynamics. |
| Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure | Baseline and Weeks 3, 6, 9, 12, 24, 52 | Bladder volume as assessed by urodynamics. |
| Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure | Baseline and Weeks 3, 6, 9, 12, 24, 52 | Bladder volume as assessed by urodynamics. |
| Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure | Baseline and Weeks 3, 6, 9, 12, 24, 52 | Bladder volume as assessed by urodynamics. |
| Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling | Baseline and Weeks 3, 6, 9, 12, 24, 52 | — |
| Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization | Baseline and Weeks 3, 6, 9, 12, 24, 36, 52 | 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 were concurrent. Catheterized volumes were recorded for 2 days in a participant diary prior to each visit. Four to six catheterizations were performed every day. |
| Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV) | Baseline and Weeks 3, 6, 9, 12, 24, 36, 52 | 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. |
| Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume | Baseline and Weeks 3, 6, 9, 12, 24, 36, 52 | The first morning catheterized volume was the volume associated with the first morning catheterization. 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. |
| Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours | Baseline and Weeks 3, 6, 9, 12, 24, 36, 52 | Participants were required to have 4-6 CICs per day on a schedule fixed for the duration of the study. To calculate the number of periods between CICs with incontinence in a diary day, the diary day was divided into periods between CICs (i.e. inter-CIC periods). The hour period, rather than the exact time, of each CIC and incontinence episode was recorded in the diary. When an incontinence episode and a CIC were marked in the same hour period, the incontinence episode was counted as occurring prior to the CIC (when the bladder had not yet emptied), rather than after it (when the bladder had recently been emptied), i.e. the inter-CIC period ended with the hour in which the CIC was recorded. The mean number of periods between CICs with incontinence per 24 hours was the number of periods between CICs when incontinence occurred, divided by the total number of valid diary days. |
| Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 3 days prior to Baseline visit | For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. |
| Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 3 days prior to Week 3 visit | For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. |
| Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 3 days prior to Week 6 visit | For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. |
| Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 3 days prior to Week 9 visit | For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. |
| Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 3 days prior to Week 12 visit | For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. |
| Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 3 days prior to Week 24 visit | For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. |
| Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 3 days prior to Week 36 visit | For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. |
| Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 3 days prior to Week 52 visit | For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all subjects. Each participant contributed to up to three days of valid diary data for each visit. |
| Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 3 days prior to Baseline visit | Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. |
| Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 3 days prior to Week 3 visit | Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. |
| Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 3 days prior to Week 6 visit | Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. |
| Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 3 days prior to Week 9 visit | Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. |
| Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 3 days prior to Week 12 visit | Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. |
| Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 3 days prior to Week 24 visit | Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. |
| Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 3 days prior to Week 36 visit | Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. |
| Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 3 days prior to Week 52 visit | Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit. |
| Change From Baseline to Week 24 and 52 in Infant and Toddler Quality of Life Short Form-47 Questionnaire (ITQoL SF-47) - Overall Health Score | Baseline and Weeks 24, 52 | The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). |
| Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Physical Abilities Score | Baseline and Weeks 24, 52 | The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). |
| Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Growth and Development Score | Baseline and Weeks 24, 52 | The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). |
| Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Pain Score | Baseline and Weeks 24, 52 | The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). |
| Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Temperament and Moods Score | Baseline and Weeks 24, 52 | The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). |
| Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Behaviour Score | Baseline and Weeks 24, 52 | The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). |
| Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC | Baseline and Weeks 3, 6, 9, 12, 52 | MCC was the volume instilled into the bladder prior to leakage or end of bladder-filling (whichever was reached first) as assessed by urodynamics (procedure: the bladder was to be filled until voiding/leakage began, or until it was stopped because either the participant experienced pain or discomfort or 135% of EBC was reached for participants ≥ 2 years or of MCV for participants aged 6 months to \< 2 years. The participants' bladder was emptied via catheterization). |
| Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Change in Health Score | Baseline and Weeks 24, 52 | The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). |
| Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Emotional Impact Score | Baseline and Weeks 24, 52 | The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). |
| Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Time Impact Score | Baseline and Weeks 24, 52 | The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). |
| Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Family Cohesion Impact Score | Baseline and Weeks 24, 52 | The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). |
| Change From Baseline to Week 24 and 52 in ITQoL SF-47 - General Health Score | Baseline and Weeks 24, 52 | The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible). |
Countries
Belgium, Philippines, Poland, South Korea, United Kingdom, United States
Participant flow
Recruitment details
Children aged 6 months to \< 5 years old with neurogenic detrusor overactivity (NDO) were enrolled from Belgium (1 site), United Kingdom (1 site), Poland (2 sites), United States (1 site), the Philippines (1 site) and South Korea (2 sites).
Pre-assignment details
Children who met the eligibility criteria were treated with sequential doses of solifenacin up to 12 weeks to determine each participant's optimal dose, after which a fixed dose of solifenacin was given for at least 40 weeks. A washout period was required between screening and baseline if the children were being treated with antimuscarinic agents.
Participants by arm
| Arm | Count |
|---|---|
| Solifenacin Succinate Children aged 6 months to less than 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Fixed-Dose Assessment Period | Lack of Efficacy | 1 |
| Titration Period | Protocol Deviation | 1 |
Baseline characteristics
| Characteristic | Solifenacin Succinate |
|---|---|
| Age, Categorical <=18 years | 23 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 35.3 months STANDARD_DEVIATION 12.7 |
| Duration of NDO Disease | 1.99 years |
| Maximum Cystometric Capacity (MCC) | 92.3 mL STANDARD_DEVIATION 38.2 |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 9 Participants |
| Weight | 13.2 kg STANDARD_DEVIATION 2.87 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 11 / 23 |
| serious Total, serious adverse events | 3 / 23 |
Outcome results
Primary
Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)
MCC was the volume instilled into the bladder prior to leakage or end of bladder-filling (whichever was reached first), as assessed by urodynamics (procedure: the bladder was to be filled until voiding/leakage began, or until it was stopped because either the participant experienced pain or discomfort or 135% of expected bladder capacity \[EBC\] was reached for participants ≥ 2 years or of maximum catheterized volume \[MCV\] for participants aged 6 months to \< 2 years; the participants' bladder was emptied via catheterization).
Time frame: Baseline and Week 24
Population: Full Analysis Set (FAS), which consisted of all participants who took at least one dose of study drug and provided both valid baseline and at least one post-baseline value for the primary efficacy endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC) | 37.0 mL | Standard Deviation 35.9 |
Comparison: Week 24 MCC Analysisp-value: <0.001t-test, 2 sided
Secondary
Change From Baseline to Week 24 and 52 in Infant and Toddler Quality of Life Short Form-47 Questionnaire (ITQoL SF-47) - Overall Health Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).
Time frame: Baseline and Weeks 24, 52
Population: FAS population with available data at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in Infant and Toddler Quality of Life Short Form-47 Questionnaire (ITQoL SF-47) - Overall Health Score | Week 24 | -1.8 units on a scale | Standard Deviation 19.2 |
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in Infant and Toddler Quality of Life Short Form-47 Questionnaire (ITQoL SF-47) - Overall Health Score | Week 52 | 9.0 units on a scale | Standard Deviation 17.4 |
Comparison: Week 24 Analysisp-value: 0.688t-test, 2 sided
Secondary
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Behaviour Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).
Time frame: Baseline and Weeks 24, 52
Population: FAS population with data available at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Behaviour Score | Week 24 | -1.69 units on a scale | Standard Deviation 8.24 |
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Behaviour Score | Week 52 | -0.06 units on a scale | Standard Deviation 6.86 |
Comparison: Week 24 Analysisp-value: 0.41t-test, 2 sided
Secondary
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Change in Health Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).
Time frame: Baseline and Weeks 24, 52
Population: FAS population with data available at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Change in Health Score | Week 24 | 0.00 units on a scale | Standard Deviation 23.39 |
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Change in Health Score | Week 52 | 5.77 units on a scale | Standard Deviation 20.8 |
Comparison: Week 24 Analysisp-value: 1t-test, 2 sided
Secondary
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Family Cohesion Impact Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).
Time frame: Baseline and Weeks 24, 52
Population: FAS population with data available at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Family Cohesion Impact Score | Week 24 | 1.5 units on a scale | Standard Deviation 16.7 |
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Family Cohesion Impact Score | Week 52 | -4.2 units on a scale | Standard Deviation 17.7 |
Comparison: Week 24 Analysisp-value: 0.721t-test, 2 sided
Secondary
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - General Health Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).
Time frame: Baseline and Weeks 24, 52
Population: FAS population with data available at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - General Health Score | Week 24 | 0.39 units on a scale | Standard Deviation 21.16 |
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - General Health Score | Week 52 | 4.29 units on a scale | Standard Deviation 17.39 |
Comparison: Week 24 Analysisp-value: 0.94t-test, 2 sided
Secondary
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Growth and Development Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).
Time frame: Baseline and Weeks 24, 52
Population: FAS population with data available at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Growth and Development Score | Week 24 | -1.50 units on a scale | Standard Deviation 11.37 |
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Growth and Development Score | Week 52 | 2.33 units on a scale | Standard Deviation 13.21 |
Comparison: Week 24 Analysisp-value: 0.562t-test, 2 sided
Secondary
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Pain Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).
Time frame: Baseline and Weeks 24, 52
Population: FAS population with data available at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Pain Score | Week 24 | -3.47 units on a scale | Standard Deviation 32.6 |
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Pain Score | Week 52 | -0.83 units on a scale | Standard Deviation 21.37 |
Comparison: Week 24 Analysisp-value: 0.657t-test, 2 sided
Secondary
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Emotional Impact Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).
Time frame: Baseline and Weeks 24, 52
Population: FAS population with data available at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Emotional Impact Score | Week 24 | -3.31 units on a scale | Standard Deviation 23.81 |
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Emotional Impact Score | Week 52 | 4.81 units on a scale | Standard Deviation 28.2 |
Comparison: Week 24 Analysisp-value: 0.575t-test, 2 sided
Secondary
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Time Impact Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).
Time frame: Baseline and Weeks 24, 52
Population: FAS population with data available at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Time Impact Score | Week 24 | 15.2 units on a scale | Standard Deviation 26.6 |
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Time Impact Score | Week 52 | 7.1 units on a scale | Standard Deviation 24.5 |
Comparison: Week 24 Analysisp-value: 0.031t-test, 2 sided
Secondary
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Physical Abilities Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).
Time frame: Baseline and Weeks 24, 52
Population: FAS population with data available at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Physical Abilities Score | Week 24 | 2.17 units on a scale | Standard Deviation 18.7 |
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Physical Abilities Score | Week 52 | 3.93 units on a scale | Standard Deviation 14.81 |
Comparison: Week 24 Analysisp-value: 0.61t-test, 2 sided
Secondary
Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Temperament and Moods Score
The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).
Time frame: Baseline and Weeks 24, 52
Population: FAS population with data available at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Temperament and Moods Score | Week 24 | -1.85 units on a scale | Standard Deviation 16.06 |
| Solifenacin Succinate | Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Temperament and Moods Score | Week 52 | -1.11 units on a scale | Standard Deviation 16.02 |
Comparison: Week 24 Analysisp-value: 0.631t-test, 2 sided
Secondary
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 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 were concurrent. Catheterized volumes were recorded for 2 days in a participant diary prior to each visit. Four to six catheterizations were performed every day.
Time frame: Baseline and Weeks 3, 6, 9, 12, 24, 36, 52
Population: FAS population with data available at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization | Week 3 | 21.56 mL | Standard Deviation 26.16 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization | Week 36 | 43.79 mL | Standard Deviation 34.13 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization | Week 52 | 40.42 mL | Standard Deviation 31.83 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization | Week 6 | 23.93 mL | Standard Deviation 23.8 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization | Week 9 | 25.13 mL | Standard Deviation 24.91 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization | Week 12 | 37.64 mL | Standard Deviation 22.43 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization | Week 24 | 34.38 mL | Standard Deviation 33.04 |
Comparison: Week 24 Analysisp-value: <0.001t-test, 2 sided
Secondary
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume
The first morning catheterized volume was the volume associated with the first morning catheterization. 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 and Weeks 3, 6, 9, 12, 24, 36, 52
Population: FAS population with data available at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume | Week 36 | 40.62 mL | Standard Deviation 44.14 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume | Week 3 | 19.47 mL | Standard Deviation 34.74 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume | Week 6 | 24.26 mL | Standard Deviation 35.49 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume | Week 9 | 23.06 mL | Standard Deviation 36.5 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume | Week 12 | 32.56 mL | Standard Deviation 35.97 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume | Week 24 | 40.58 mL | Standard Deviation 41.89 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume | Week 52 | 39.88 mL | Standard Deviation 34.91 |
Comparison: Week 24 Analysisp-value: 0.001t-test, 2 sided
Secondary
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV)
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 and Weeks 3, 6, 9, 12, 24, 36, 52
Population: FAS population with data available at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV) | Week 3 | 30.00 mL | Standard Deviation 32.06 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV) | Week 6 | 31.06 mL | Standard Deviation 34.36 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV) | Week 9 | 27.31 mL | Standard Deviation 33.34 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV) | Week 12 | 40.56 mL | Standard Deviation 24.64 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV) | Week 24 | 40.56 mL | Standard Deviation 51.45 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV) | Week 36 | 57.91 mL | Standard Deviation 47.67 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV) | Week 52 | 41.69 mL | Standard Deviation 46.71 |
Comparison: Week 24 Analysisp-value: 0.004t-test, 2 sided
Secondary
Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours
Participants were required to have 4-6 CICs per day on a schedule fixed for the duration of the study. To calculate the number of periods between CICs with incontinence in a diary day, the diary day was divided into periods between CICs (i.e. inter-CIC periods). The hour period, rather than the exact time, of each CIC and incontinence episode was recorded in the diary. When an incontinence episode and a CIC were marked in the same hour period, the incontinence episode was counted as occurring prior to the CIC (when the bladder had not yet emptied), rather than after it (when the bladder had recently been emptied), i.e. the inter-CIC period ended with the hour in which the CIC was recorded. The mean number of periods between CICs with incontinence per 24 hours was the number of periods between CICs when incontinence occurred, divided by the total number of valid diary days.
Time frame: Baseline and Weeks 3, 6, 9, 12, 24, 36, 52
Population: FAS population with data available at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours | Week 36 | -1.06 periods | Standard Deviation 1.25 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours | Week 6 | -1.38 periods | Standard Deviation 1.21 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours | Week 9 | -1.47 periods | Standard Deviation 1.19 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours | Week 12 | -1.25 periods | Standard Deviation 1.32 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours | Week 24 | -1.31 periods | Standard Deviation 1.39 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours | Week 3 | -1.18 periods | Standard Deviation 1.42 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours | Week 52 | -1.29 periods | Standard Deviation 1.42 |
Comparison: Week 24 Analysisp-value: 0.001t-test, 2 sided
Secondary
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance
Bladder compliance gives an indication of the elasticity of the bladder wall. Bladder compliance was calculated by dividing the change in volume during the filling of the bladder by the change in detrusor pressure during that change in bladder volume using urodynamic assessments. The values for bladder volume and detrusor pressure at the beginning and end of filling were taken and used.
Time frame: Baseline and Weeks 3, 6, 9, 12, 24, 52
Population: FAS population with available data at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance | Week 3 | 4.55 mL/cmH2O | Standard Deviation 4.3 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance | Week 6 | 5.45 mL/cmH2O | Standard Deviation 8.45 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance | Week 9 | 10.00 mL/cmH2O | Standard Deviation 16.42 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance | Week 12 | 4.14 mL/cmH2O | Standard Deviation 4.2 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance | Week 24 | 5.10 mL/cmH2O | Standard Deviation 6.82 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance | Week 52 | 5.94 mL/cmH2O | Standard Deviation 4.24 |
Comparison: Week 24 Analysisp-value: 0.003t-test, 2 sided
Secondary
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure
Bladder volume as assessed by urodynamics.
Time frame: Baseline and Weeks 3, 6, 9, 12, 24, 52
Population: FAS population with data available at baseline and at each time point and whose pressure reached 10 cmH2O.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure | Week 3 | 31.9 mL | Standard Deviation 47.3 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure | Week 6 | 47.8 mL | Standard Deviation 55.9 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure | Week 9 | 31.5 mL | Standard Deviation 54.1 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure | Week 52 | 49.4 mL | Standard Deviation 40.9 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure | Week 12 | 30.1 mL | Standard Deviation 37.9 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure | Week 24 | 28.7 mL | Standard Deviation 47.9 |
Comparison: Week 24 Analyisp-value: 0.025t-test, 2 sided
Secondary
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure
Bladder volume as assessed by urodynamics.
Time frame: Baseline and Weeks 3, 6, 9, 12, 24, 52
Population: FAS population with data available at baseline and at each time point and whose pressure reached 20 cmH2O.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure | Week 3 | 52.4 mL | Standard Deviation 59.4 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure | Week 6 | 65.5 mL | Standard Deviation 54.9 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure | Week 9 | 52.0 mL | Standard Deviation 58 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure | Week 52 | 75.4 mL | Standard Deviation 71.6 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure | Week 12 | 53.9 mL | Standard Deviation 67.6 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure | Week 24 | 40.1 mL | Standard Deviation 56.2 |
Comparison: Week 24 Analysisp-value: 0.05t-test, 2 sided
Secondary
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure
Bladder volume as assessed by urodynamics.
Time frame: Baseline and Weeks 3, 6, 9, 12, 24, 52
Population: FAS population with data available at baseline and at each time point and whose pressure reached 30 cmH2O.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure | Week 3 | 101.9 mL | Standard Deviation 0.2 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure | Week 6 | -2.3 mL | — |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure | Week 9 | 76.0 mL | Standard Deviation 120.2 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure | Week 12 | 74.7 mL | Standard Deviation 54.9 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure | Week 24 | 67.5 mL | Standard Deviation 118.1 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure | Week 52 | 93.6 mL | — |
Comparison: Week 24 Analysisp-value: 0.567t-test, 2 sided
Secondary
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O)
Bladder volume as assessed by urodynamics.
Time frame: Baseline and Weeks 3, 6, 9, 12, 24, 52
Population: FAS population with data available at baseline and at each time point and excluding participants who did not have a detrusor contraction.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O) | Week 3 | 47.0 mL | Standard Deviation 31.3 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O) | Week 6 | 87.4 mL | Standard Deviation 57.4 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O) | Week 52 | 89.2 mL | Standard Deviation 58 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O) | Week 9 | 77.0 mL | Standard Deviation 86.2 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O) | Week 12 | 18.7 mL | Standard Deviation 37.5 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O) | Week 24 | 22.9 mL | Standard Deviation 52.3 |
Comparison: Week 24 Analysisp-value: 0.177t-test, 2 sided
Secondary
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling
Catheterized volume was measured when the bladder was emptied via catheterization 5 minutes after the end of bladder-filling.
Time frame: Baseline and Weeks 3, 6, 9, 12, 24, 52
Population: FAS population with available data at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling | Week 9 | 50.5 mL | Standard Deviation 40.5 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling | Week 12 | 50.5 mL | Standard Deviation 46.6 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling | Week 24 | 44.0 mL | Standard Deviation 29.5 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling | Week 52 | 59.8 mL | Standard Deviation 27 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling | Week 3 | 38.6 mL | Standard Deviation 52.6 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling | Week 6 | 41.8 mL | Standard Deviation 25.5 |
Comparison: Week 24 Analysisp-value: <0.001t-test, 2 sided
Secondary
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling
Detrusor pressure was expressed as bladder pressure minus intra-abdominal pressure as assessed by urodynamics.
Time frame: Baseline and Weeks 3, 6, 9, 12, 24, 52
Population: FAS population with with available data at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling | Week 3 | 0.9 cmH2O | Standard Deviation 8.4 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling | Week 6 | 1.3 cmH2O | Standard Deviation 10.4 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling | Week 9 | 1.2 cmH2O | Standard Deviation 11.8 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling | Week 12 | -4.1 cmH2O | Standard Deviation 10.9 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling | Week 24 | -2.0 cmH2O | Standard Deviation 9.4 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling | Week 52 | -2.3 cmH2O | Standard Deviation 14.7 |
Comparison: Week 24 Analysisp-value: 0.352t-test, 2 sided
Secondary
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling
Detrusor pressure was expressed as bladder pressure minus intra-abdominal pressure as assessed by urodynamics.
Time frame: Baseline and Weeks 3, 6, 9, 12, 24, 52
Population: FAS population with available data at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling | Week 3 | -5.2 cmH2O | Standard Deviation 12.9 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling | Week 6 | -8.3 cmH2O | Standard Deviation 14.8 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling | Week 9 | -10.3 cmH2O | Standard Deviation 18.2 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling | Week 12 | -0.6 cmH2O | Standard Deviation 23.4 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling | Week 24 | -1.0 cmH2O | Standard Deviation 13.9 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling | Week 52 | -9.8 cmH2O | Standard Deviation 19.2 |
Comparison: Week 24 Analysisp-value: 0.744t-test, 2 sided
Secondary
Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling
Time frame: Baseline and Weeks 3, 6, 9, 12, 24, 52
Population: FAS population with data available at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling | Week 24 | -7.0 contractions | Standard Deviation 8.6 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling | Week 52 | -7.2 contractions | Standard Deviation 10.2 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling | Week 3 | -3.4 contractions | Standard Deviation 3.9 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling | Week 6 | -4.2 contractions | Standard Deviation 5.3 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling | Week 9 | -6.3 contractions | Standard Deviation 6.6 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling | Week 12 | -6.8 contractions | Standard Deviation 8.9 |
Comparison: Week 24 Analysisp-value: 0.001t-test, 2 sided
Secondary
Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC
MCC was the volume instilled into the bladder prior to leakage or end of bladder-filling (whichever was reached first) as assessed by urodynamics (procedure: the bladder was to be filled until voiding/leakage began, or until it was stopped because either the participant experienced pain or discomfort or 135% of EBC was reached for participants ≥ 2 years or of MCV for participants aged 6 months to \< 2 years. The participants' bladder was emptied via catheterization).
Time frame: Baseline and Weeks 3, 6, 9, 12, 52
Population: FAS population with available data at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC | Week 6 | 36.5 mL | Standard Deviation 36.6 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC | Week 3 | 45.2 mL | Standard Deviation 44.8 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC | Week 9 | 23.9 mL | Standard Deviation 57.6 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC | Week 12 | 40.2 mL | Standard Deviation 37.9 |
| Solifenacin Succinate | Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC | Week 52 | 58.6 mL | Standard Deviation 34.1 |
Secondary
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline
For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.
Time frame: 3 days prior to Baseline visit
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 03:00-04:00 | 3.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 04:00-05:00 | 0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 05:00-06:00 | 13.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 06:00-07:00 | 46.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 07:00-08:00 | 29.6 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 08:00-09:00 | 18.5 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 09:00-10:00 | 27.8 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 10:00-11:00 | 16.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 11:00-12:00 | 22.2 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 12:00-13:00 | 44.4 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 13:00-14:00 | 20.4 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 14:00-15:00 | 20.4 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 15:00-16:00 | 24.1 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 16:00-17:00 | 27.8 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 17:00-18:00 | 14.8 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 18:00-19:00 | 40.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 19:00-20:00 | 31.5 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 20:00-21:00 | 13.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 21:00-22:00 | 38.9 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 22:00-23:00 | 14.8 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 23:00-00:00 | 13.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 00:00-01:00 | 24.1 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 01:00-02:00 | 9.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline | 02:00-03:00 | 1.9 percentage of days with catheterization |
Secondary
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12
For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.
Time frame: 3 days prior to Week 12 visit
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 16:00-17:00 | 31.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 17:00-18:00 | 15.9 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 06:00-07:00 | 39.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 07:00-08:00 | 31.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 08:00-09:00 | 20.6 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 09:00-10:00 | 27.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 10:00-11:00 | 19.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 11:00-12:00 | 15.9 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 12:00-13:00 | 58.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 13:00-14:00 | 19.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 14:00-15:00 | 12.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 15:00-16:00 | 22.2 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 18:00-19:00 | 41.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 19:00-20:00 | 22.2 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 20:00-21:00 | 27.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 21:00-22:00 | 38.1 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 22:00-23:00 | 11.1 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 23:00-00:00 | 14.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 00:00-01:00 | 30.2 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 01:00-02:00 | 1.6 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 02:00-03:00 | 3.2 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 03:00-04:00 | 3.2 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 04:00-05:00 | 0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 | 05:00-06:00 | 6.3 percentage of days with catheterization |
Secondary
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24
For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.
Time frame: 3 days prior to Week 24 visit
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 08:00-09:00 | 22.2 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 06:00-07:00 | 33.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 07:00-08:00 | 33.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 09:00-10:00 | 15.9 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 10:00-11:00 | 23.8 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 11:00-12:00 | 19.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 12:00-13:00 | 44.4 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 13:00-14:00 | 33.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 14:00-15:00 | 9.5 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 15:00-16:00 | 23.8 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 16:00-17:00 | 27.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 17:00-18:00 | 27.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 18:00-19:00 | 34.9 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 19:00-20:00 | 30.2 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 20:00-21:00 | 20.6 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 21:00-22:00 | 38.1 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 22:00-23:00 | 6.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 23:00-00:00 | 17.5 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 00:00-01:00 | 25.4 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 01:00-02:00 | 3.2 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 02:00-03:00 | 3.2 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 03:00-04:00 | 0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 04:00-05:00 | 0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 | 05:00-06:00 | 6.3 percentage of days with catheterization |
Secondary
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3
For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.
Time frame: 3 days prior to Week 3 visit
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 06:00-07:00 | 36.5 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 07:00-08:00 | 30.2 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 08:00-09:00 | 20.6 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 09:00-10:00 | 27.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 10:00-11:00 | 20.6 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 11:00-12:00 | 19.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 12:00-13:00 | 36.5 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 13:00-14:00 | 34.9 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 14:00-15:00 | 15.9 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 15:00-16:00 | 23.8 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 16:00-17:00 | 20.6 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 17:00-18:00 | 28.6 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 18:00-19:00 | 36.5 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 19:00-20:00 | 25.4 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 20:00-21:00 | 20.6 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 21:00-22:00 | 36.5 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 22:00-23:00 | 17.5 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 23:00-00:00 | 9.5 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 00:00-01:00 | 25.4 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 01:00-02:00 | 12.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 02:00-03:00 | 3.2 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 03:00-04:00 | 0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 04:00-05:00 | 0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 | 05:00-06:00 | 11.1 percentage of days with catheterization |
Secondary
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36
For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.
Time frame: 3 days prior to Week 36 visit
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 06:00-07:00 | 36.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 07:00-08:00 | 35.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 08:00-09:00 | 26.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 09:00-10:00 | 20.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 10:00-11:00 | 16.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 11:00-12:00 | 16.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 12:00-13:00 | 53.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 13:00-14:00 | 30.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 14:00-15:00 | 8.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 15:00-16:00 | 25.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 16:00-17:00 | 26.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 17:00-18:00 | 23.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 18:00-19:00 | 43.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 19:00-20:00 | 21.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 20:00-21:00 | 23.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 21:00-22:00 | 38.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 22:00-23:00 | 5.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 23:00-00:00 | 15.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 00:00-01:00 | 25.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 01:00-02:00 | 5.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 02:00-03:00 | 1.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 03:00-04:00 | 0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 04:00-05:00 | 1.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 | 05:00-06:00 | 1.7 percentage of days with catheterization |
Secondary
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52
For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all subjects. Each participant contributed to up to three days of valid diary data for each visit.
Time frame: 3 days prior to Week 52 visit
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 01:00-02:00 | 0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 06:00-07:00 | 35.1 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 07:00-08:00 | 33.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 08:00-09:00 | 28.1 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 09:00-10:00 | 22.8 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 10:00-11:00 | 15.8 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 11:00-12:00 | 17.5 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 12:00-13:00 | 50.9 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 13:00-14:00 | 26.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 14:00-15:00 | 10.5 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 15:00-16:00 | 28.1 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 16:00-17:00 | 19.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 17:00-18:00 | 24.6 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 18:00-19:00 | 45.6 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 19:00-20:00 | 24.6 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 20:00-21:00 | 21.1 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 21:00-22:00 | 36.8 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 22:00-23:00 | 15.8 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 23:00-00:00 | 19.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 00:00-01:00 | 14.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 02:00-03:00 | 0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 03:00-04:00 | 0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 04:00-05:00 | 0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 | 05:00-06:00 | 3.5 percentage of days with catheterization |
Secondary
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6
For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.
Time frame: 3 days prior to Week 6 visit
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 21:00-22:00 | 40.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 22:00-23:00 | 18.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 23:00-00:00 | 16.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 06:00-07:00 | 35.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 07:00-08:00 | 30.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 08:00-09:00 | 20.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 09:00-10:00 | 36.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 10:00-11:00 | 15.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 11:00-12:00 | 11.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 12:00-13:00 | 43.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 13:00-14:00 | 33.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 14:00-15:00 | 15.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 15:00-16:00 | 30.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 16:00-17:00 | 25.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 17:00-18:00 | 20.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 18:00-19:00 | 35.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 19:00-20:00 | 28.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 20:00-21:00 | 11.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 00:00-01:00 | 18.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 01:00-02:00 | 0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 02:00-03:00 | 5.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 03:00-04:00 | 3.3 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 04:00-05:00 | 0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 | 05:00-06:00 | 6.7 percentage of days with catheterization |
Secondary
Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9
For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.
Time frame: 3 days prior to Week 9 visit
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 14:00-15:00 | 17.5 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 06:00-07:00 | 34.9 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 07:00-08:00 | 36.5 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 08:00-09:00 | 19.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 09:00-10:00 | 23.8 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 10:00-11:00 | 17.5 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 11:00-12:00 | 19.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 12:00-13:00 | 42.9 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 13:00-14:00 | 27.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 15:00-16:00 | 31.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 16:00-17:00 | 15.9 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 17:00-18:00 | 23.8 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 18:00-19:00 | 38.1 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 19:00-20:00 | 27.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 20:00-21:00 | 17.5 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 21:00-22:00 | 38.1 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 22:00-23:00 | 12.7 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 23:00-00:00 | 19.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 00:00-01:00 | 19.0 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 01:00-02:00 | 4.8 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 02:00-03:00 | 1.6 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 03:00-04:00 | 1.6 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 04:00-05:00 | 1.6 percentage of days with catheterization |
| Solifenacin Succinate | Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 | 05:00-06:00 | 9.5 percentage of days with catheterization |
Secondary
Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline
Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.
Time frame: 3 days prior to Baseline visit
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 06:00-07:00 | 27.8 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 07:00-08:00 | 27.8 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 08:00-09:00 | 16.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 09:00-10:00 | 37.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 10:00-11:00 | 25.9 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 11:00-12:00 | 22.2 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 12:00-13:00 | 35.2 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 13:00-14:00 | 33.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 14:00-15:00 | 25.9 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 15:00-16:00 | 31.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 16:00-17:00 | 37.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 17:00-18:00 | 24.1 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 18:00-19:00 | 24.1 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 19:00-20:00 | 31.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 20:00-21:00 | 14.8 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 21:00-22:00 | 35.2 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 22:00-23:00 | 14.8 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 23:00-00:00 | 9.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 00:00-01:00 | 13.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 01:00-02:00 | 5.6 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 02:00-03:00 | 1.9 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 03:00-04:00 | 1.9 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 04:00-05:00 | 1.9 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline | 05:00-06:00 | 7.4 percentage of days with incontinence |
Secondary
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12
Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.
Time frame: 3 days prior to Week 12 visit
Population: FAS population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 09:00-10:00 | 28.6 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 22:00-23:00 | 9.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 23:00-00:00 | 6.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 00:00-01:00 | 4.8 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 01:00-02:00 | 1.6 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 02:00-03:00 | 1.6 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 03:00-04:00 | 1.6 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 04:00-05:00 | 0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 05:00-06:00 | 7.9 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 06:00-07:00 | 17.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 07:00-08:00 | 11.1 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 08:00-09:00 | 9.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 10:00-11:00 | 22.2 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 11:00-12:00 | 23.8 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 12:00-13:00 | 25.4 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 13:00-14:00 | 4.8 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 14:00-15:00 | 9.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 15:00-16:00 | 28.6 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 16:00-17:00 | 12.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 17:00-18:00 | 17.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 18:00-19:00 | 17.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 19:00-20:00 | 17.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 20:00-21:00 | 12.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 | 21:00-22:00 | 11.1 percentage of days with incontinence |
Secondary
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24
Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.
Time frame: 3 days prior to Week 24 visit
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 06:00-07:00 | 25.4 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 07:00-08:00 | 14.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 08:00-09:00 | 7.9 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 09:00-10:00 | 15.9 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 10:00-11:00 | 31.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 11:00-12:00 | 23.8 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 12:00-13:00 | 11.1 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 13:00-14:00 | 11.1 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 14:00-15:00 | 9.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 15:00-16:00 | 25.4 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 16:00-17:00 | 14.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 17:00-18:00 | 30.2 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 18:00-19:00 | 17.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 19:00-20:00 | 19.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 20:00-21:00 | 15.9 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 21:00-22:00 | 7.9 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 22:00-23:00 | 7.9 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 23:00-00:00 | 6.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 00:00-01:00 | 3.2 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 01:00-02:00 | 3.2 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 02:00-03:00 | 1.6 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 03:00-04:00 | 0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 04:00-05:00 | 0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 | 05:00-06:00 | 4.8 percentage of days with incontinence |
Secondary
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36
Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.
Time frame: 3 days prior to Week 36 visit
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 06:00-07:00 | 25.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 07:00-08:00 | 13.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 08:00-09:00 | 11.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 09:00-10:00 | 18.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 10:00-11:00 | 20.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 11:00-12:00 | 20.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 12:00-13:00 | 21.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 13:00-14:00 | 13.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 14:00-15:00 | 11.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 15:00-16:00 | 31.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 16:00-17:00 | 11.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 23:00-00:00 | 11.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 00:00-01:00 | 6.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 01:00-02:00 | 3.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 02:00-03:00 | 0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 03:00-04:00 | 1.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 04:00-05:00 | 1.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 17:00-18:00 | 16.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 18:00-19:00 | 11.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 19:00-20:00 | 30.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 20:00-21:00 | 21.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 21:00-22:00 | 18.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 22:00-23:00 | 5.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 | 05:00-06:00 | 5.0 percentage of days with incontinence |
Secondary
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52
Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.
Time frame: 3 days prior to Week 52 visit
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 06:00-07:00 | 19.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 08:00-09:00 | 17.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 14:00-15:00 | 12.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 15:00-16:00 | 29.8 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 07:00-08:00 | 19.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 09:00-10:00 | 14.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 10:00-11:00 | 24.6 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 11:00-12:00 | 33.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 12:00-13:00 | 17.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 13:00-14:00 | 8.8 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 16:00-17:00 | 17.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 17:00-18:00 | 22.8 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 18:00-19:00 | 19.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 19:00-20:00 | 21.1 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 20:00-21:00 | 17.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 21:00-22:00 | 21.1 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 22:00-23:00 | 1.8 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 23:00-00:00 | 3.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 00:00-01:00 | 5.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 01:00-02:00 | 3.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 02:00-03:00 | 3.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 03:00-04:00 | 1.8 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 04:00-05:00 | 5.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 | 05:00-06:00 | 3.5 percentage of days with incontinence |
Secondary
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6
Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.
Time frame: 3 days prior to Week 6 visit
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 15:00-16:00 | 26.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 16:00-17:00 | 21.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 17:00-18:00 | 23.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 18:00-19:00 | 15.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 19:00-20:00 | 25.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 20:00-21:00 | 10.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 21:00-22:00 | 23.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 22:00-23:00 | 5.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 23:00-00:00 | 5.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 00:00-01:00 | 0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 01:00-02:00 | 0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 02:00-03:00 | 3.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 03:00-04:00 | 1.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 04:00-05:00 | 3.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 05:00-06:00 | 5.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 06:00-07:00 | 25.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 07:00-08:00 | 18.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 08:00-09:00 | 11.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 09:00-10:00 | 11.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 10:00-11:00 | 20.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 11:00-12:00 | 20.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 12:00-13:00 | 13.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 13:00-14:00 | 6.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 | 14:00-15:00 | 11.7 percentage of days with incontinence |
Secondary
Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9
Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.
Time frame: 3 days prior to Week 9 visit
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 20:00-21:00 | 14.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 01:00-02:00 | 3.2 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 02:00-03:00 | 1.6 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 03:00-04:00 | 3.2 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 04:00-05:00 | 1.6 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 05:00-06:00 | 9.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 06:00-07:00 | 14.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 07:00-08:00 | 20.6 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 08:00-09:00 | 9.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 09:00-10:00 | 9.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 10:00-11:00 | 25.4 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 11:00-12:00 | 22.2 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 12:00-13:00 | 11.1 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 13:00-14:00 | 11.1 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 14:00-15:00 | 12.7 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 15:00-16:00 | 22.2 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 16:00-17:00 | 20.6 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 17:00-18:00 | 20.6 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 18:00-19:00 | 11.1 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 19:00-20:00 | 15.9 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 21:00-22:00 | 11.1 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 22:00-23:00 | 6.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 23:00-00:00 | 4.8 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 | 00:00-01:00 | 1.6 percentage of days with incontinence |
Secondary
Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3
Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.
Time frame: 3 days prior to Week 3 visit
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 09:00-10:00 | 22.2 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 06:00-07:00 | 17.5 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 07:00-08:00 | 25.4 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 08:00-09:00 | 11.1 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 10:00-11:00 | 22.2 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 11:00-12:00 | 14.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 12:00-13:00 | 15.9 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 13:00-14:00 | 15.9 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 14:00-15:00 | 20.6 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 15:00-16:00 | 20.6 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 16:00-17:00 | 15.9 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 17:00-18:00 | 20.6 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 18:00-19:00 | 14.3 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 19:00-20:00 | 27.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 20:00-21:00 | 19.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 21:00-22:00 | 19.0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 22:00-23:00 | 3.2 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 23:00-00:00 | 7.9 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 00:00-01:00 | 4.8 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 01:00-02:00 | 3.2 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 02:00-03:00 | 1.6 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 03:00-04:00 | 1.6 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 04:00-05:00 | 0 percentage of days with incontinence |
| Solifenacin Succinate | Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 | 05:00-06:00 | 9.5 percentage of days with incontinence |