Treatment with Botox in patients with urinary incontinence (accidental loss of urine) due to neurogenic detrusor overactivity (bladder problems resulting from disease or damage to the nervous system

Phase 1

Conditions: Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
rinary incontinence due to neurogenic detrusor overactivity
MedDRA version: 18.0Level: PTClassification code 10029279Term: Neurogenic bladderSystem Organ Class: 10038359 - Renal and urinary disorders

Registration Number: EUCTR2014-004641-27-BE

Lead Sponsor: ZLeuven

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

- Male or female, = 0 and = 17 years of age at the moment of signing the informed consent
- Patient with neurogenic bladder dysfunction shown during urodynamic investigation with or without overactive detrusor contraction
- Neurogenic detrusor overactivity caused by;
* spinal dysrafie, more specifically spina bifida (e.g. myelomeningocele, meningocele) and all forms of tethered cord
* Acquired neurogenic detrusor overactivity due to spinal cord injury
- Regular intermittent sondage to empty the bladder
- more than 4 episodes of urine incontinence over two days in the miction diary
- the neurogenic bladder dysfunction is not sufficiently controlled with anticholinergics only
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- occurence of uncontrolled systemic diseases
- occurence of malignancies
- spinal cord surgery during the past 6 months
- additional pelvic or urologic abnormalities (open bladder neck, urethra stricture/urethra valve
- predominance of stress incontinence

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Children who are still incontinent but have no shown detrusor contraction during urodynamic investigation;Secondary Objective: Not applicable;Primary end point(s): - efficacy: The data of the miction diaries are studied during use of intradetrusor injections with Botox<br>- Safety: To confirm the safety of Botox in children on the basis of medical history, clinical investigation and labo;Timepoint(s) of evaluation of this end point: - Screening<br>- Treatment<br>- Visits: week 2, 6, 12, 24, 36 and 48<br>- Calls: week 18, 30 and 42

Secondary Outcome Measures