A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity

Allergan

Status and phase: Completed; Phase 3

Conditions: Urinary Incontinence

Treatments: Biological: OnabotulinumtoxinA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01852058

191622-121

2012-004898-30 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA (botulinum toxin Type A; BOTOX®) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in participants who successfully completed Study 191622-120 (NCT01852045).

Enrollment: 95 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Successfully completed participation in Study 191622-120
• Aged ≥ 5 years to ≤ 17 years at the time of entry into Study 191622-120
• Regularly using clean intermittent catheterization to empty the bladder

Exclusion criteria

• Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
• Current or planned use of a baclofen pump
• Current or planned use of an electrostimulation/neuromodulation device for urinary incontinence
• Use of an indwelling catheter for urinary incontinence instead of using clean intermittent catheterization to empty the bladder
• Previous or current use of botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype for any other condition since entering study 191622-120

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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95 participants in 3 patient groups

OnabotulinumtoxinA 50 U

Experimental group

Description:

Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).

Treatment:

Biological: OnabotulinumtoxinA

OnabotulinumtoxinA 100 U

Experimental group

Description:

Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).

Treatment:

Biological: OnabotulinumtoxinA

OnabotulinumtoxinA 200 U

Experimental group

Description:

Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).

Treatment:

Biological: OnabotulinumtoxinA