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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Other interventions - 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).


Other interventions: 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
Other interventions
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) - Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible, at Baseline and Week 6. A positive change from Baseline indicated improvement.
Timepoint [1] 0 0
Baseline, Week 6
Primary outcome [2] 0 0
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) - Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FEV1, the maximum amount of air exhaled in one second, at Baseline and Week 6. The highest value at each time-point was recorded. A positive change from Baseline indicated improvement.
Timepoint [2] 0 0
Baseline, Week 6
Primary outcome [3] 0 0
Change From Baseline in FEV1/FVC Ratio - The FEV1/FVC ratio was calculated by dividing the FEV1 value by the FVC value representing the portion (or ratio) of FVC exhaled in one second. A positive change from Baseline indicated improvement.
Timepoint [3] 0 0
Baseline, Week 6
Secondary outcome [1] 0 0
Change From Baseline in the Number of Urinary Incontinence Episodes - The number of urinary incontinence episodes or leakage occurring over the previous 3 days was recorded in the patient bladder diary at Baseline and prior to Week 6. A negative change from Baseline indicated improvement (less incontinence/leakage).
Timepoint [1] 0 0
Baseline, Week 6
Secondary outcome [2] 0 0
Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP) - MDP was measured at the first involuntary detrusor contraction using urodynamic testing. A catheter was inserted into the bladder at Baseline and Week 6 and the pressure [measured in centimeters water (cm H20)] was determined as the bladder filled. A negative change from Baseline indicated improvement (less Detrusor pressure).
Timepoint [2] 0 0
Baseline, Week 6
Secondary outcome [3] 0 0
Change From Baseline in Maximum Cystometric Capacity (MCC) - MCC (the maximum amount of urine the bladder could hold) was measured using urodynamic testing. The amount of urine collected was subtracted from the total volume infused measured as milliliters (mL) of urine. A positive change from Baseline indicated improvement (fuller bladder/ less incontinence).
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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/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/show/NCT00439140