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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Secondary ID [1] 0 0
191622-094
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overactive Bladder 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Botulinum Toxin Type A 300U
Treatment: Other - 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.


Treatment: Other: Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor \> 12 weeks as needed for up to 3 years.

Treatment: Other: Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor \> 12 weeks as needed for up to 3 years.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Assessment method [1] 0 0
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).
Timepoint [1] 0 0
Study Baseline, Week 6 Treatment Cycle 1
Primary outcome [2] 0 0
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Assessment method [2] 0 0
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).
Timepoint [2] 0 0
Study Baseline, Week 6 Treatment Cycle 2
Primary outcome [3] 0 0
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Assessment method [3] 0 0
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).
Timepoint [3] 0 0
Study Baseline, Week 6 Treatment Cycle 3
Primary outcome [4] 0 0
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Assessment method [4] 0 0
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).
Timepoint [4] 0 0
Study Baseline, Week 6 Treatment Cycle 4
Primary outcome [5] 0 0
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Assessment method [5] 0 0
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).
Timepoint [5] 0 0
Study Baseline, Week 6 Treatment Cycle 5
Secondary outcome [1] 0 0
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Study Baseline, Week 6 Treatment Cycle 1
Secondary outcome [2] 0 0
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Study Baseline, Week 6 Treatment Cycle 2
Secondary outcome [3] 0 0
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Study Baseline, Week 6 Treatment Cycle 3
Secondary outcome [4] 0 0
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Study Baseline, Week 6 Treatment Cycle 4
Secondary outcome [5] 0 0
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Study Baseline, Week 6 Treatment Cycle 5
Secondary outcome [6] 0 0
Change From Study Baseline in Volume Per Void
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Study Baseline, Week 6 Treatment Cycle 1
Secondary outcome [7] 0 0
Change From Study Baseline in Volume Per Void
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
Study Baseline, Week 6 Treatment Cycle 2
Secondary outcome [8] 0 0
Change From Study Baseline in Volume Per Void
Assessment method [8] 0 0
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.
Timepoint [8] 0 0
Study Baseline, Week 6 Treatment Cycle 3
Secondary outcome [9] 0 0
Change From Study Baseline in Volume Per Void
Assessment method [9] 0 0
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.
Timepoint [9] 0 0
Study Baseline, Week 6 Treatment Cycle 4
Secondary outcome [10] 0 0
Change From Study Baseline in Volume Per Void
Assessment method [10] 0 0
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.
Timepoint [10] 0 0
Study Baseline, Week 6 Treatment Cycle 5

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History or evidence of pelvic or urologic abnormality.
* Previous or current diagnosis of bladder or prostate cancer.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/09/2013
Sample size
Target
Accrual to date
Final
397
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Randwick
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Belgium
State/province [3] 0 0
Ghent
Country [4] 0 0
Brazil
State/province [4] 0 0
Rio de Janeiro
Country [5] 0 0
Canada
State/province [5] 0 0
British Columbia
Country [6] 0 0
Czechia
State/province [6] 0 0
Ostrava
Country [7] 0 0
France
State/province [7] 0 0
Salouel
Country [8] 0 0
Germany
State/province [8] 0 0
Kiel
Country [9] 0 0
Italy
State/province [9] 0 0
Florence
Country [10] 0 0
Netherlands
State/province [10] 0 0
Amsterdam
Country [11] 0 0
New Zealand
State/province [11] 0 0
Epsom
Country [12] 0 0
Poland
State/province [12] 0 0
Poznan
Country [13] 0 0
Portugal
State/province [13] 0 0
Porto
Country [14] 0 0
Russian Federation
State/province [14] 0 0
Moscow
Country [15] 0 0
Singapore
State/province [15] 0 0
Singapore
Country [16] 0 0
Slovakia
State/province [16] 0 0
Presov
Country [17] 0 0
South Africa
State/province [17] 0 0
Pretoria
Country [18] 0 0
Spain
State/province [18] 0 0
Tenerife
Country [19] 0 0
Taiwan
State/province [19] 0 0
Hualien
Country [20] 0 0
Ukraine
State/province [20] 0 0
Kiev
Country [21] 0 0
United Kingdom
State/province [21] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00876447