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)

• Status: Completed
• Trial end date: 2015-12-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Europe B.V.
• Treatments: Solifenacin Succinate

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