CompletedPhase 3

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)

United States, Belgium, Philippines23 participantsStarted 2013-09-25

Plain-language 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.

Who can participate

Age range

6 Months – 4 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)

Timeframe: Baseline and Week 24

Trial details

NCT IDNCT01981954

SponsorAstellas Pharma Europe B.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-12-18

Results submitted2018-05-23

View on ClinicalTrials.gov More Neurogenic Detrusor Overactivity trials

Who can participate

Age range

6 Months – 4 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.