Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction

Recruiting Phase 3 Interventional Study
Spina Bifida
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
6 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Central Hospital, Nancy, France · Other
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About This Trial
Malformation of the lumbosacral region (spina bifida) affects the innervation of the bladder in children. The usual evolution leads to a neurological bladder with small capacity, poor compliancy and overactivity, exposing to incontinence and obstruction to the evacuation of urine. It is responsible for renal failure requiring dialysis and transplantation. Current therapeutics aim to evacuate urine…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Person affiliated to or beneficiary of a social security plan * In failure of treatment with one or more anticholinergics defined by a response considered insufficient by the investigator after at least 4 weeks of optimal dose treatment, unable to take oral oxybutynin or intol…
Contacts

Nicolas BERTE, Dr

0383155287

n.berte@chru-nancy.fr

CONTACT

Jean-Louis LEMELLE, Pr

0383154729

jl.lemelle@chru-nancy.fr

CONTACT