Phase 1 trial of botulinum toxin therapy in Japanese children with urinary incontinence due to neurogenic detrusor overactivity

Sato Hiroyuki0 个研究点目标入组 12 人开始时间: 2020年1月1日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•1. aged >= 5 years to =<18 years of age
•2. Patient has NDO due to Organic spinal cord lesions: Spinal fusion failure including spina bifida, spinal cord injury, transverse myelitis, other organic spinal cord lesions
•3. Neurological lesion must be at thoracic level T1 or below
•4.the CIC schedule must be at least 3 times per day, and CIC must have been initiated at least 3 months prior to screening
•5. patient has a total of >=2 urinary incontinence episode more than 5 days a week
•6. patient have not been adequately managed with one or more anticholinergics
•7. patients who gained informed consent has been obtained from the patient or the substitutents of patients

•1.patient has the following uncontrolled systemic disease, previous or current diagnosis of malignancy
•(a)cerebral palsy
•(b)epilepsy
•(c)patient has a history of dysphagia, aspiration pneumonia, or significant lung disease (eg, bronchiectasis)
•(d)Other diseases that affect the implementation of this study treatment
•2.patient has a history or evidence of any urological abnormalities, except vesicoureteral reflux
•3.patients using indwelling catheters
•4.patient has had surgery of the spinal cord, the urinary tract or bladder within 6 months
•5.postmenarche female patients who are pregnant, nursing, or planning to become pregnant during the study
•6.patient judged by researchers not appropriate

发起方

Sato Hiroyuki