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

This study has been terminated.
(The study was terminated early due to enrollment challenges.)
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00575016
First received: December 13, 2007
Last updated: September 9, 2011
Last verified: September 2011

December 13, 2007
September 9, 2011
December 2007
February 2010   (final data collection date for primary outcome measure)
Change From Baseline in Number of Weekly Episodes of Urinary Incontinence [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Number of episodes of urinary incontinence
Complete list of historical versions of study NCT00575016 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Maximum Cystometric Capacity (MCC) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.
  • Change From Baseline in Maximum Detrusor Pressure (MDP) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.
Urodynamic parameters
Not Provided
Not Provided
 
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Overactive Bladder
  • Biological: Normal saline (Placebo); botulinum toxin Type A (200U)
    Placebo injection on Day 1 and botulinum toxin Type A injection 200 U > Week 12; injection into the detrusor
    Other Name: BOTOX®
  • Biological: botulinum toxin Type A (50U); botulinum toxin Type A (200U)
    botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
    Other Name: BOTOX®
  • Biological: botulinum toxin Type A (100U); botulinum toxin Type A (200U)
    botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
    Other Name: BOTOX®
  • Biological: botulinum toxin Type A (200U)
    botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
    Other Name: BOTOX®
  • Experimental: 1
    botulinum toxin Type A (50U); botulinum toxin Type A (200U)
    Intervention: Biological: botulinum toxin Type A (50U); botulinum toxin Type A (200U)
  • Experimental: 2
    botulinum toxin Type A (100U); botulinum toxin Type A (200U)
    Intervention: Biological: botulinum toxin Type A (100U); botulinum toxin Type A (200U)
  • Experimental: 3
    botulinum toxin Type A (200U)
    Intervention: Biological: botulinum toxin Type A (200U)
  • 4
    placebo; botulinum toxin Type A (200U)
    Intervention: Biological: Normal saline (Placebo); botulinum toxin Type A (200U)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
74
July 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt,   Greece,   India,   Lebanon,   Serbia,   Turkey
 
NCT00575016
191622-518
Not Provided
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP