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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00461292
First received: April 13, 2007
Last updated: September 9, 2011
Last verified: September 2011
History of Changes

April 13, 2007
September 9, 2011
May 2007
March 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 NCT00461292 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 the 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.
  • Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement.
Urodynamic Parameters, 24-hour urine volume voided
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 assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Overactive Bladder
  • Biological: botulinum toxin Type A (200U)
    botulinum toxin Type A 200 U injection at Day 1 followed by botulinum toxin Type A 200 U injection > Week 12; injections into detrusor
    Other Name: BOTOX®
  • Biological: botulinum toxin Type A (300U)
    botulinum toxin Type A 300 U injection on Day 1 followed by botulinum toxin Type A 300 U injection > Week 12; injections into detrusor
    Other Name: BOTOX®
  • Other: Normal saline (Placebo); botulinum toxin Type A (200U)
    Placebo injection on Day 1 followed by botulinum toxin Type A 200 U injection > 12 weeks; injections into detrusor
    Other Name: BOTOX®
  • Other: Normal saline (Placebo); botulinum toxin Type A (300U)
    Placebo injection on Day 1 followed by botulinum toxin Type A 300 U injection > Week 12; injections into detrusor
    Other Name: BOTOX®
  • Experimental: 1
    botulinum toxin Type A (200U)
    Intervention: Biological: botulinum toxin Type A (200U)
  • Experimental: 2
    botulinum toxin Type A (300U)
    Intervention: Biological: botulinum toxin Type A (300U)
  • 3
    placebo; botulinum toxin Type A (200U)
    Intervention: Other: Normal saline (Placebo); botulinum toxin Type A (200U)
  • 4
    placebo; botulinum toxin Type A (300U)
    Intervention: Other: Normal saline (Placebo); botulinum toxin Type A (300U)
Cruz F, Herschorn S, Aliotta P, Brin M, Thompson C, Lam W, Daniell G, Heesakkers J, Haag-Molkenteller C. Efficacy and safety of onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2011 Oct;60(4):742-50. Epub 2011 Jul 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
275
April 2010
March 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 or multiple sclerosis
  • 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
United States,   Brazil,   Canada,   France,   Italy,   Netherlands,   Portugal,   Singapore,   South Africa,   Spain,   Taiwan,   United Kingdom
 
NCT00461292
191622-516
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