Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
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
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
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
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
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
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
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
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
Timepoint [5] 0 0
Study Baseline, Week 6 Treatment Cycle 5
Secondary outcome [6] 0 0
Change From Study Baseline in Volume Per Void
Timepoint [6] 0 0
Study Baseline, Week 6 Treatment Cycle 1
Secondary outcome [7] 0 0
Change From Study Baseline in Volume Per Void
Timepoint [7] 0 0
Study Baseline, Week 6 Treatment Cycle 2
Secondary outcome [8] 0 0
Change From Study Baseline in Volume Per Void
Timepoint [8] 0 0
Study Baseline, Week 6 Treatment Cycle 3
Secondary outcome [9] 0 0
Change From Study Baseline in Volume Per Void
Timepoint [9] 0 0
Study Baseline, Week 6 Treatment Cycle 4
Secondary outcome [10] 0 0
Change From Study Baseline in Volume Per Void
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
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT00876447
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.
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00876447