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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/NCT00876447
Registration number
NCT00876447
Ethics application status
Date submitted
1/04/2009
Date registered
6/04/2009
Date last updated
1/05/2019
Titles & IDs
Public title
A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis
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Scientific title
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Secondary ID [1]
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191622-094
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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 300U
Other interventions - Botulinum Toxin Type A 200U
Experimental: Botulinum Toxin Type A 300U - Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
Experimental: Botulinum Toxin Type A 200U - Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Other interventions: Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
Other interventions: Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
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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 Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
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Assessment method [1]
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Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
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Timepoint [1]
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Study Baseline, Week 6 Treatment Cycle 1
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Primary outcome [2]
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Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
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Assessment method [2]
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Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
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Timepoint [2]
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Study Baseline, Week 6 Treatment Cycle 2
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Primary outcome [3]
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Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
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Assessment method [3]
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Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
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Timepoint [3]
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Study Baseline, Week 6 Treatment Cycle 3
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Primary outcome [4]
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Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
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Assessment method [4]
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Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
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Timepoint [4]
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Study Baseline, Week 6 Treatment Cycle 4
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Primary outcome [5]
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Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
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Assessment method [5]
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Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
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Timepoint [5]
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Study Baseline, Week 6 Treatment Cycle 5
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Secondary outcome [1]
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Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
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Assessment method [1]
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The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the 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). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
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Timepoint [1]
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Study Baseline, Week 6 Treatment Cycle 1
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Secondary outcome [2]
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Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
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Assessment method [2]
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The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the 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). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
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Timepoint [2]
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Study Baseline, Week 6 Treatment Cycle 2
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Secondary outcome [3]
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Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
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Assessment method [3]
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The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the 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). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
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Timepoint [3]
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Study Baseline, Week 6 Treatment Cycle 3
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Secondary outcome [4]
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Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
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Assessment method [4]
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The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the 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). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
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Timepoint [4]
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Study Baseline, Week 6 Treatment Cycle 4
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Secondary outcome [5]
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Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
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Assessment method [5]
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The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the 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). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
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Timepoint [5]
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Study Baseline, Week 6 Treatment Cycle 5
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Secondary outcome [6]
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Change From Study Baseline in Volume Per Void
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Assessment method [6]
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The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
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Timepoint [6]
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Study Baseline, Week 6 Treatment Cycle 1
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Secondary outcome [7]
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Change From Study Baseline in Volume Per Void
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Assessment method [7]
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The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
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Timepoint [7]
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Study Baseline, Week 6 Treatment Cycle 2
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Secondary outcome [8]
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Change From Study Baseline in Volume Per Void
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Assessment method [8]
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The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
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Timepoint [8]
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Study Baseline, Week 6 Treatment Cycle 3
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Secondary outcome [9]
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Change From Study Baseline in Volume Per Void
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Assessment method [9]
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The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
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Timepoint [9]
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Study Baseline, Week 6 Treatment Cycle 4
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Secondary outcome [10]
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Change From Study Baseline in Volume Per Void
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Assessment method [10]
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The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
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Timepoint [10]
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Study Baseline, Week 6 Treatment Cycle 5
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Eligibility
Key inclusion criteria
- Patient has participated in study 191622-515 or 191622-516 and the following criteria
fulfilled:
- Patient completed at least 52 weeks in the preceding study.
- No longer than 6 months has elapsed since completion of the preceding study
- Patient has not received any prohibited medications during any intervening period
between the preceding study and this long-term study.
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Minimum age
18
Years
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Maximum age
No limit
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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 or evidence of pelvic or urologic abnormality.
- Previous or current diagnosis of bladder or prostate cancer.
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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
1/01/2009
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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
4/09/2013
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Sample size
Target
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Accrual to date
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Final
397
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Recruitment in Australia
Recruitment state(s)
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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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Connecticut
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Austria
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State/province [2]
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Innsbruck
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Belgium
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Ghent
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Brazil
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State/province [4]
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Rio de Janeiro
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Canada
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State/province [5]
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British Columbia
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Czechia
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State/province [6]
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Ostrava
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France
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State/province [7]
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Salouel
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Germany
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Kiel
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Italy
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Florence
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Netherlands
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Amsterdam
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New Zealand
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State/province [11]
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Epsom
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Poland
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State/province [12]
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Poznan
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Portugal
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State/province [13]
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Porto
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Russian Federation
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State/province [14]
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Moscow
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Singapore
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State/province [15]
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Singapore
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Country [16]
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Slovakia
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State/province [16]
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Presov
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South Africa
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State/province [17]
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Pretoria
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Spain
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State/province [18]
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Tenerife
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Taiwan
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State/province [19]
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Hualien
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Country [20]
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Ukraine
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State/province [20]
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Kiev
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Country [21]
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United Kingdom
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State/province [21]
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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 long-term safety and effectiveness of botulinum
toxin type A on patients with overactive bladder as a result of spinal cord injury or
multiple sclerosis. This is a follow-up study to two Allergan sponsored studies (NCT00311376
and NCT00461292).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00876447
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Trial related presentations / publications
Kennelly M, Dmochowski R, Schulte-Baukloh H, Ethans K, Del Popolo G, Moore C, Jenkins B, Guard S, Zheng Y, Karsenty G; 191622-094 Investigators. Efficacy and safety of onabotulinumtoxinA therapy are sustained over 4 years of treatment in patients with neurogenic detrusor overactivity: Final results of a long-term extension study. Neurourol Urodyn. 2017 Feb;36(2):368-375. doi: 10.1002/nau.22934. Epub 2015 Nov 24.
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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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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/NCT00876447
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