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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Secondary ID [1] 0 0
191622-515
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 (200U)
Treatment: Other - 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)


Treatment: Other: 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

Treatment: Other: 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
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Number of Weekly Episodes of Urinary Incontinence
Timepoint [1] 0 0
Baseline, Week 6
Secondary outcome [1] 0 0
Change From Baseline in Maximum Cystometric Capacity (MCC)
Timepoint [1] 0 0
Baseline, Week 6
Secondary outcome [2] 0 0
Change From Baseline in Maximum Detrusor Pressure (MDP)
Timepoint [2] 0 0
Baseline, Week 6
Secondary outcome [3] 0 0
Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire
Timepoint [3] 0 0
Baseline, Week 6

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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2010
Sample size
Target
Accrual to date
Final
416
Recruitment in Australia
Recruitment state(s)
NSW
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
Michigan
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Belgium
State/province [3] 0 0
Gent
Country [4] 0 0
Canada
State/province [4] 0 0
Sherbrooke
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Ostrava
Country [6] 0 0
France
State/province [6] 0 0
Garches
Country [7] 0 0
Germany
State/province [7] 0 0
Halle (Saale)
Country [8] 0 0
New Zealand
State/province [8] 0 0
Christchurch
Country [9] 0 0
Poland
State/province [9] 0 0
Wroclaw
Country [10] 0 0
Russian Federation
State/province [10] 0 0
Moscow
Country [11] 0 0
Slovakia
State/province [11] 0 0
Martin
Country [12] 0 0
Ukraine
State/province [12] 0 0
Lviv
Country [13] 0 0
United Kingdom
State/province [13] 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 safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.
Trial website
https://clinicaltrials.gov/study/NCT00311376
Trial related presentations / publications
Cuervo J, Castejon N, Khalaf KM, Waweru C, Globe D, Patrick DL. Development of the Incontinence Utility Index: estimating population-based utilities associated with urinary problems from the Incontinence Quality of Life Questionnaire and Neurogenic Module. Health Qual Life Outcomes. 2014 Oct 8;12:147. doi: 10.1186/s12955-014-0147-7.
Chancellor MB, Patel V, Leng WW, Shenot PJ, Lam W, Globe DR, Loeb AL, Chapple CR. OnabotulinumtoxinA improves quality of life in patients with neurogenic detrusor overactivity. Neurology. 2013 Aug 27;81(9):841-8. doi: 10.1212/WNL.0b013e3182a2ca4d. Epub 2013 Jul 26.
Ginsberg D, Gousse A, Keppenne V, Sievert KD, Thompson C, Lam W, Brin MF, Jenkins B, Haag-Molkenteller C. Phase 3 efficacy and tolerability study of onabotulinumtoxinA for urinary incontinence from neurogenic detrusor overactivity. J Urol. 2012 Jun;187(6):2131-9. doi: 10.1016/j.juro.2012.01.125. Epub 2012 Apr 12.
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/NCT00311376