A Research Study for Patients With Overactive Bladder

Allergan

Status and phase: Completed; Phase 2

Conditions: Urinary Incontinence; Overactive Bladder

Treatments: Drug: Placebo; Biological: botulinum toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00168454

191622-077

Details and patient eligibility

About

The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.

Enrollment: 313 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be between 18-85 years old
• Must have been diagnosed by his/her doctor with overactive bladder at least 6 months ago
• Must weigh at least 50 kg (110 lbs)
• Must be willing and able to record information regarding bladder function into a diary (provided)
• Must be willing and able to complete the entire course of the study

Exclusion criteria

• Cannot currently be catheterizing as a way to control incontinence
• Must not have used botulinum toxin type A or any other botulinum toxin previously for any condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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313 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo (normal saline) injected into detrusor on Day 1

Treatment:

Drug: Placebo

BOTOX 50 U

Experimental group

Description:

botulinum toxin Type A 50 U injected into detrusor on Day 1

Treatment:

Biological: botulinum toxin Type A

BOTOX 100 U

Experimental group

Description:

botulinum toxin Type A 100 U injected into detrusor on Day 1

Treatment:

Biological: botulinum toxin Type A

BOTOX 150 U

Experimental group

Description:

botulinum toxin Type A 150 U injected into detrusor on Day 1

Treatment:

Biological: botulinum toxin Type A

BOTOX 200 U

Experimental group

Description:

botulinum toxin Type A 200 U injected into detrusor on Day 1

Treatment:

Biological: botulinum toxin Type A

BOTOX 300 U

Experimental group

Description:

botulinum toxin Type A 300 U injected into detrusor on Day 1

Treatment:

Biological: botulinum toxin Type A