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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00439140




Registration number
NCT00439140
Ethics application status
Date submitted
21/02/2007
Date registered
23/02/2007
Date last updated
24/01/2014

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
191622-082
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
Treatment: Drugs - Normal Saline (Placebo)

Experimental: botulinum toxin Type A 200U - Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).

Experimental: botulinum toxin Type A 300U - Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).

Other: Placebo/botulinum toxin Type A 200U - Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).

Other: Placebo/botulinum toxin Type A 300U - Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 300U injection (200U after discontinuation of 300U) after a minimum of 12 weeks (if applicable).


Treatment: Other: botulinum toxin Type A
Botulinum toxin Type A injection into the detrusor.

Treatment: Drugs: Normal Saline (Placebo)
Placebo (Normal Saline) injection into the detrusor.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Forced Vital Capacity (FVC)
Timepoint [1] 0 0
Baseline, Week 6
Primary outcome [2] 0 0
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Timepoint [2] 0 0
Baseline, Week 6
Primary outcome [3] 0 0
Change From Baseline in FEV1/FVC Ratio
Timepoint [3] 0 0
Baseline, Week 6
Secondary outcome [1] 0 0
Change From Baseline in the Number of Urinary Incontinence Episodes
Timepoint [1] 0 0
Baseline, Week 6
Secondary outcome [2] 0 0
Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP)
Timepoint [2] 0 0
Baseline, Week 6
Secondary outcome [3] 0 0
Change From Baseline in Maximum Cystometric Capacity (MCC)
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.
* Neurological respiratory impairment and abnormal pulmonary function test results
Minimum age
18 Years
Maximum age
80 Years
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
* Symptomatic or untreated 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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
- Herston
Recruitment postcode(s) [1] 0 0
- Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
India
State/province [3] 0 0
Chennai

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of urinary incontinence overactive bladder in patients with a spinal cord injury or multiple sclerosis.
Trial website
https://clinicaltrials.gov/study/NCT00439140
Trial related presentations / publications
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/NCT00439140