Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

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Allergan

Status and phase

Terminated
Phase 2

Conditions

Overactive Bladder

Treatments

Biological: botulinum toxin Type A (200U)
Biological: botulinum toxin Type A (50U); botulinum toxin Type A (200U)
Biological: Normal saline (Placebo); botulinum toxin Type A (200U)
Biological: botulinum toxin Type A (100U); botulinum toxin Type A (200U)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00575016
191622-518

Details and patient eligibility

About

The purpose of this study is to explore the effectiveness and safety of several doses of botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.

Enrollment

74 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury
  • Inadequate response to anticholinergic medication used to treat overactive bladder

Exclusion criteria

  • History or evidence of pelvic or urologic abnormality
  • Previous or current diagnosis of bladder or prostate cancer
  • Urinary tract infection at time of enrollment

Trial design

74 participants in 4 patient groups

1
Experimental group
Description:
botulinum toxin Type A (50U); botulinum toxin Type A (200U)
Treatment:
Biological: botulinum toxin Type A (50U); botulinum toxin Type A (200U)
2
Experimental group
Description:
botulinum toxin Type A (100U); botulinum toxin Type A (200U)
Treatment:
Biological: botulinum toxin Type A (100U); botulinum toxin Type A (200U)
3
Experimental group
Description:
botulinum toxin Type A (200U)
Treatment:
Biological: botulinum toxin Type A (200U)
4
Other group
Description:
placebo; botulinum toxin Type A (200U)
Treatment:
Biological: Normal saline (Placebo); botulinum toxin Type A (200U)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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