Neurogenic detrusor overactivity, NDO
Conditions
Interventions
The 10 mL of study drug will be administered to bladder wall as 20 injections each of 0.5 mL.
Sponsors
Sato Hiroyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. aged >= 5 years to ==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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome(s)Dose Limiting Toxicity Recommended Dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with improved urinary incontinence per day Changes in the number of incontinences per day Changes in health outcomes Usefulness based on modified Total Benefit Scale (mTBS) Quality of life based on Dysfunctional Voiding Symptom Score (DVSS) Quality of Life (QOL) based on Pediatric Incontinence Questionaire (PinQ) Incidence rate of adverse events Each severity, recovery, causal relationship with study treatment, dose correlation | — |
Contacts
Public ContactAtsuko Sato
Tokyo Metropolitan Children's Medical Center
Outcome results
None listed