Phase 3
N=23
A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)
Neurogenic Detrusor Overactivity · Pediatric
Bottom Line
View on ClinicalTrials.gov: NCT01981954 ↗Enrolled (actual)
23
Serious AEs
13.0%
Results posted
Jun 2018
Primary outcome: Primary: Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC) — 37.0 mL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Solifenacin succinate (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Astellas Pharma Europe B.V.
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC) |
37.0 | <0.001 sig |
| SECONDARY Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC |
45.2; 36.5; 23.9; 40.2; 58.6 | — |
| SECONDARY Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance |
4.55; 5.45; 10.00; 4.14; 5.10; 5.94 | 0.003 sig |
| SECONDARY Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling |
-5.2; -8.3; -10.3; -0.6; -1.0; -9.8 | 0.744 |
| SECONDARY Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling |
0.9; 1.3; 1.2; -4.1; -2.0; -2.3 | 0.352 |
| SECONDARY Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling |
38.6; 41.8; 50.5; 50.5; 44.0; 59.8 | <0.001 sig |
| SECONDARY Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O) |
47.0; 87.4; 77.0; 18.7; 22.9; 89.2 | 0.177 |
| SECONDARY Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure |
31.9; 47.8; 31.5; 30.1; 28.7; 49.4 | 0.025 sig |
| SECONDARY Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure |
52.4; 65.5; 52.0; 53.9; 40.1; 75.4 | 0.050 |
| SECONDARY Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure |
101.9; -2.3; 76.0; 74.7; 67.5; 93.6 | 0.567 |
| 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 |
-3.4; -4.2; -6.3; -6.8; -7.0; -7.2 | 0.001 sig |
| SECONDARY Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization |
21.56; 23.93; 25.13; 37.64; 34.38; 43.79 | <0.001 sig |
| SECONDARY Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV) |
30.00; 31.06; 27.31; 40.56; 40.56; 57.91 | 0.004 sig |
| SECONDARY Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume |
19.47; 24.26; 23.06; 32.56; 40.58; 40.62 | 0.001 sig |
| 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 |
-1.18; -1.38; -1.47; -1.25; -1.31; -1.06 | 0.001 sig |
| SECONDARY Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline |
46.3; 29.6; 18.5; 27.8; 16.7; 22.2 | — |
| SECONDARY Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3 |
36.5; 30.2; 20.6; 27.0; 20.6; 19.0 | — |
| SECONDARY Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6 |
35.0; 30.0; 20.0; 36.7; 15.0; 11.7 | — |
| SECONDARY Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9 |
34.9; 36.5; 19.0; 23.8; 17.5; 19.0 | — |
| SECONDARY Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12 |
39.7; 31.7; 20.6; 27.0; 19.0; 15.9 | — |
| SECONDARY Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24 |
33.3; 33.3; 22.2; 15.9; 23.8; 19.0 | — |
| SECONDARY Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36 |
36.7; 35.0; 26.7; 20.0; 16.7; 16.7 | — |
| SECONDARY Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52 |
35.1; 33.3; 28.1; 22.8; 15.8; 17.5 | — |
| SECONDARY Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline |
27.8; 27.8; 16.7; 37.0; 25.9; 22.2 | — |
| SECONDARY Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3 |
17.5; 25.4; 11.1; 22.2; 22.2; 14.3 | — |
| SECONDARY Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6 |
25.0; 18.3; 11.7; 11.7; 20.0; 20.0 | — |
| SECONDARY Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9 |
14.3; 20.6; 9.5; 9.5; 25.4; 22.2 | — |
| SECONDARY Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12 |
17.5; 11.1; 9.5; 28.6; 22.2; 23.8 | — |
| SECONDARY Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24 |
25.4; 14.3; 7.9; 15.9; 31.7; 23.8 | — |
| SECONDARY Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36 |
25.0; 13.3; 11.7; 18.3; 20.0; 20.0 | — |
| SECONDARY Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52 |
19.3; 19.3; 17.5; 14.0; 24.6; 33.3 | — |
| 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 |
-1.8; 9.0 | 0.688 |
| SECONDARY Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Physical Abilities Score |
2.17; 3.93 | 0.610 |
| SECONDARY Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Growth and Development Score |
-1.50; 2.33 | 0.562 |
| SECONDARY Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Pain Score |
-3.47; -0.83 | 0.657 |
| SECONDARY Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Temperament and Moods Score |
-1.85; -1.11 | 0.631 |
| SECONDARY Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Behaviour Score |
-1.69; -0.06 | 0.410 |
| SECONDARY Change From Baseline to Week 24 and 52 in ITQoL SF-47 - General Health Score |
0.39; 4.29 | 0.940 |
| SECONDARY Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Change in Health Score |
0.00; 5.77 | 1.000 |
| SECONDARY Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Emotional Impact Score |
-3.31; 4.81 | 0.575 |
| SECONDARY Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Time Impact Score |
15.2; 7.1 | 0.031 sig |
| SECONDARY Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Family Cohesion Impact Score |
1.5; -4.2 | 0.721 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01981954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.