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

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ClinicalTrials.gov Identifier: NCT00575016
Recruitment Status : Terminated (The study was terminated early due to enrollment challenges.)
First Posted : December 17, 2007
Results First Posted : October 17, 2011
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Biological: Normal saline (Placebo); botulinum toxin Type A (200U) Biological: botulinum toxin Type A (50U); botulinum toxin Type A (200U) Biological: botulinum toxin Type A (100U); botulinum toxin Type A (200U) Biological: botulinum toxin Type A (200U) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2007
Primary Completion Date : February 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
botulinum toxin Type A (50U); botulinum toxin Type A (200U)
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®
Experimental: 2
botulinum toxin Type A (100U); botulinum toxin Type A (200U)
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®
Experimental: 3
botulinum toxin Type A (200U)
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®
4
placebo; botulinum toxin Type A (200U)
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®


Outcome Measures

Primary Outcome Measures :
  1. Change From Baseline in Number of Weekly Episodes of Urinary Incontinence [ Time Frame: Baseline, Week 6 ]
    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).


Secondary Outcome Measures :
  1. Change From Baseline in Maximum Cystometric Capacity (MCC) [ Time Frame: Baseline, Week 6 ]
    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.

  2. Change From Baseline in Maximum Detrusor Pressure (MDP) [ Time Frame: Baseline, Week 6 ]
    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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575016


Locations
Egypt
Cairo, Egypt
Greece
Thessaloniki, Greece
India
Ahmadabad, India
Lebanon
Beirut, Lebanon
Serbia
Belgrade, Serbia
Turkey
Ankara, Turkey
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00575016     History of Changes
Other Study ID Numbers: 191622-518
First Posted: December 17, 2007    Key Record Dates
Results First Posted: October 17, 2011
Last Update Posted: October 2, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents