Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00311376 |
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Recruitment Status :
Completed
First Posted : April 6, 2006
Results First Posted : October 17, 2011
Last Update Posted : December 4, 2015
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Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Overactive Bladder | Biological: botulinum toxin Type A (200U) Biological: botulinum toxin Type A (300U) Other: Normal Saline (Placebo); botulinum toxin Type A (200U) Other: Normal Saline (Placebo); botulinum toxin Type A (300U) | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 416 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Study Start Date : | August 2006 |
| Actual Primary Completion Date : | May 2010 |
| Actual Study Completion Date : | May 2010 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
botulinum toxin Type A (200U)
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Biological: botulinum toxin Type A (200U)
botulinum toxin Type A 200 U (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at > 12 weeks interval
Other Name: BOTOX® |
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Experimental: 2
botulinum toxin Type A (300U)
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Biological: botulinum toxin Type A (300U)
botulinum toxin Type A 300 U (tx 1) followed by botulinum toxin Type A 300 U (tx 2); injections into detrusor, at > 12 weeks interval
Other Name: BOTOX® |
|
3
placebo; botulinum toxin Type A (200U)
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Other: Normal Saline (Placebo); botulinum toxin Type A (200U)
Placebo (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at > 12 weeks interval
Other Name: BOTOX® |
|
4
placebo; botulinum toxin Type A (300U)
|
Other: Normal Saline (Placebo); botulinum toxin Type A (300U)
Placebo (tx 1) followed by botulinum toxin Type A 300 U (tx 2), injections into detrusor, at > 12 weeks interval
Other Name: BOTOX® |
Primary Outcome Measures :
- 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 :
- 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.
- 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.
- Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire [ Time Frame: Baseline, Week 6 ]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
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| 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 or multiple sclerosis
- Inadequate response to anticholinergic medication used to treat overactive bladder
Exclusion Criteria:
- History of evidence of pelvic or urologic abnormality
- Previous or current diagnosis of bladder or prostate cancer
- Urinary tract infection at time of enrollment
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): NCT00311376
Locations
| United States, Michigan | |
| Royal Oak, Michigan, United States | |
| Australia, New South Wales | |
| Randwick, New South Wales, Australia | |
| Austria | |
| Innsbruck, Austria | |
| Belgium | |
| Gent, Belgium | |
| Canada | |
| Sherbrooke, Canada | |
| Czech Republic | |
| Ostrava, Czech Republic | |
| France | |
| Garches, France | |
| Germany | |
| Halle (Saale), Germany | |
| New Zealand | |
| Christchurch, New Zealand | |
| Poland | |
| Wroclaw, Poland | |
| Russian Federation | |
| Moscow, Russian Federation | |
| Slovakia | |
| Martin, Slovakia | |
| Ukraine | |
| Lviv, Ukraine | |
| United Kingdom | |
| London, United Kingdom | |
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Medical Director | Allergan |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT00311376 |
| Other Study ID Numbers: |
191622-515 |
| First Posted: | April 6, 2006 Key Record Dates |
| Results First Posted: | October 17, 2011 |
| Last Update Posted: | December 4, 2015 |
| Last Verified: | November 2015 |
Additional relevant MeSH terms:
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Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Botulinum Toxins 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 |