Phase 1 trial of botulinum toxin therapy in Japanese children with urinary incontinence due to neurogenic detrusor overactivity
- Conditions
- eurogenic detrusor overactivity, NDO
- Registration Number
- JPRN-jRCTs031190132
- Lead Sponsor
- Sato Hiroyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome(s)Dose Limiting Toxicity<br>Recommended Dose
- Secondary Outcome Measures
Name Time Method Percentage of patients with improved urinary incontinence per day<br>Changes in the number of incontinences per day<br>Changes in health outcomes<br>Usefulness based on modified Total Benefit Scale (mTBS)<br>Quality of life based on Dysfunctional Voiding Symptom Score (DVSS)<br>Quality of Life (QOL) based on Pediatric Incontinence Questionaire (PinQ)<br>Incidence rate of adverse events<br>Each severity, recovery, causal relationship with study treatment, dose correlation