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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00311376
Registration number
NCT00311376
Ethics application status
Date submitted
4/04/2006
Date registered
6/04/2006
Date last updated
4/12/2015
Titles & IDs
Public title
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
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Scientific title
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Secondary ID [1]
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191622-515
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Overactive Bladder
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Condition category
Condition code
Renal and Urogenital
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - botulinum toxin Type A (200U)
Other interventions - botulinum toxin Type A (300U)
Other interventions - Normal Saline (Placebo); botulinum toxin Type A (200U)
Other interventions - Normal Saline (Placebo); botulinum toxin Type A (300U)
Experimental: 1 - botulinum toxin Type A (200U)
Experimental: 2 - botulinum toxin Type A (300U)
Other: 3 - placebo; botulinum toxin Type A (200U)
Other: 4 - placebo; botulinum toxin Type A (300U)
Other interventions: 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 interventions: 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 interventions: 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 interventions: 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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Number of Weekly Episodes of Urinary Incontinence
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline, Week 6
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Secondary outcome [1]
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Change From Baseline in Maximum Cystometric Capacity (MCC)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Week 6
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Secondary outcome [2]
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Change From Baseline in Maximum Detrusor Pressure (MDP)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, Week 6
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Secondary outcome [3]
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Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire
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Assessment method [3]
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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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Timepoint [3]
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Baseline, Week 6
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2010
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Sample size
Target
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Accrual to date
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Final
416
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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- Randwick
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Recruitment postcode(s) [1]
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- Randwick
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Michigan
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Country [2]
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Austria
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State/province [2]
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Innsbruck
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Country [3]
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Belgium
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State/province [3]
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Gent
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Country [4]
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Canada
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State/province [4]
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Sherbrooke
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Country [5]
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Czech Republic
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State/province [5]
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Ostrava
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Country [6]
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France
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State/province [6]
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Garches
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Country [7]
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Germany
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State/province [7]
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Halle (Saale)
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Country [8]
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New Zealand
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State/province [8]
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Christchurch
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Country [9]
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Poland
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State/province [9]
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Wroclaw
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Country [10]
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Russian Federation
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State/province [10]
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Moscow
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Country [11]
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Slovakia
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State/province [11]
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Martin
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Country [12]
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Ukraine
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State/province [12]
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Lviv
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Country [13]
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United Kingdom
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State/province [13]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allergan
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00311376
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Allergan
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00311376
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