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

BOTOX in the treatment of urinary incontinence due to neurogenic detrusor overactivity in patients 3 months - 17 years - Botox treatment

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004641-27-BE

Enrollment

Registered

2015-04-21

Start date

Unknown

Completion date

Unknown

Last updated

2018-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary incontinence due to neurogenic detrusor overactivity MedDRA version: 18.0 Level: PT Classification code 10029279 Term: Neurogenic bladder System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Trade Name: Botox Pharmaceutical Form: Intravesical solution/solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 - 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 - Treatment - Visits: week 2, 6, 12, 24, 36 and 48 - Calls: week 18, 30 and 42	—

Measure

Time frame

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 - 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 - Treatment - Visits: week 2, 6, 12, 24, 36 and 48 - Calls: week 18, 30 and 42

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactUrology trial

UZLeuven

guy.bogaert@uzleuven.be3216346930

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026