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Trial record 1 of 1 for:    NCT00910845
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Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

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ClinicalTrials.gov Identifier: NCT00910845
Recruitment Status : Completed
First Posted : June 1, 2009
Results First Posted : March 5, 2013
Last Update Posted : March 5, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Overactive Bladder
Interventions Biological: onabotulinumtoxinA
Drug: normal saline
Enrollment 557
Recruitment Details  
Pre-assignment Details  
Arm/Group Title onabotulinumtoxinA Placebo/onabotulinumtoxinA
Hide Arm/Group Description OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
Period Title: Treatment Cycle 1
Started 280 277
Completed 249 243
Not Completed 31 34
Period Title: Treatment Cycle 2
Started 141 [1] 212 [1]
Completed 136 203
Not Completed 5 9
[1]
Not all participants who completed Treatment Cycle 1 went onto Treatment Cycle 2
Arm/Group Title onabotulinumtoxinA Placebo/onabotulinumtoxinA Total
Hide Arm/Group Description OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable). Total of all reporting groups
Overall Number of Baseline Participants 280 277 557
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 280 participants 277 participants 557 participants
< 40 years 9 17 26
Between 40 and 64 years 150 143 293
Between 65 and 74 years 75 73 148
≥ 75 years 46 44 90
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 277 participants 557 participants
Female
252
  90.0%
245
  88.4%
497
  89.2%
Male
28
  10.0%
32
  11.6%
60
  10.8%
1.Primary Outcome
Title Change From Baseline in Number of Daily Episodes of Urinary Incontinence
Hide Description A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population included all randomized patients.
Arm/Group Title onabotulinumtoxinA Placebo/onabotulinumtoxinA
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
Overall Number of Participants Analyzed 280 277
Mean (Standard Deviation)
Unit of Measure: Incontinence episodes
Baseline 5.47  (3.621) 5.09  (3.204)
Change from Baseline at Week 12 -2.65  (3.333) -0.87  (2.833)
2.Secondary Outcome
Title Change From Baseline in Number of Daily Micturition Episodes
Hide Description The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population included all randomized patients.
Arm/Group Title onabotulinumtoxinA Placebo/onabotulinumtoxinA
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
Overall Number of Participants Analyzed 280 277
Mean (Standard Deviation)
Unit of Measure: micturition episodes
Baseline 11.98  (4.259) 11.20  (3.070)
Change from Baseline at Week 12 -2.15  (2.933) -0.91  (2.577)
3.Secondary Outcome
Title Change From Baseline in Volume Voided Per Micturition
Hide Description The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population included all randomized patients.
Arm/Group Title onabotulinumtoxinA Placebo/onabotulinumtoxinA
Hide Arm/Group Description:
OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
Overall Number of Participants Analyzed 280 277
Mean (Standard Deviation)
Unit of Measure: milliliters
Baseline 156.4  (63.21) 161.1  (68.65)
Change from Baseline at Week 12 41.1  (87.58) 9.7  (59.02)
Time Frame [Not Specified]
Adverse Event Reporting Description The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
 
Arm/Group Title onabotulinumtoxinA Placebo/onabotulinumtoxinA
Hide Arm/Group Description OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
All-Cause Mortality
onabotulinumtoxinA Placebo/onabotulinumtoxinA
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
onabotulinumtoxinA Placebo/onabotulinumtoxinA
Affected / at Risk (%) Affected / at Risk (%)
Total   18/278 (6.47%)   16/272 (5.88%) 
Cardiac disorders     
Coronary artery disease  1  1/278 (0.36%)  1/272 (0.37%) 
Myocardial infarction  1  1/278 (0.36%)  0/272 (0.00%) 
Angina pectoris  1  0/278 (0.00%)  1/272 (0.37%) 
Congenital, familial and genetic disorders     
Foramen magnum stenosis  1  1/278 (0.36%)  0/272 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/278 (0.36%)  0/272 (0.00%) 
Gastrointestinal disorders     
Colitis  1  1/278 (0.36%)  0/272 (0.00%) 
Volvulus  1  1/278 (0.36%)  0/272 (0.00%) 
Intestinal perforation  1  0/278 (0.00%)  1/272 (0.37%) 
Infections and infestations     
Pneumonia  1  2/278 (0.72%)  0/272 (0.00%) 
Diverticulitis  1  1/278 (0.36%)  1/272 (0.37%) 
Abscess limb  1  1/278 (0.36%)  0/272 (0.00%) 
Appendiceal abscess  1  1/278 (0.36%)  0/272 (0.00%) 
Folliculitis  1  1/278 (0.36%)  0/272 (0.00%) 
Pneumocystis jiroveci pneumonia  1  1/278 (0.36%)  0/272 (0.00%) 
Abscess  1  0/278 (0.00%)  1/272 (0.37%) 
Injury, poisoning and procedural complications     
Cervical vertebral fracture  1  1/278 (0.36%)  0/272 (0.00%) 
Femur fracture  1  0/278 (0.00%)  1/272 (0.37%) 
Procedural hypotension  1  0/278 (0.00%)  1/272 (0.37%) 
Metabolism and nutrition disorders     
Dehydration  1  1/278 (0.36%)  2/272 (0.74%) 
Obesity  1  1/278 (0.36%)  1/272 (0.37%) 
Electrolyte imbalance  1  0/278 (0.00%)  1/272 (0.37%) 
Hypokalaemia  1  0/278 (0.00%)  1/272 (0.37%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  1/278 (0.36%)  3/272 (1.10%) 
Arthritis  1  1/278 (0.36%)  1/272 (0.37%) 
Spinal column stenosis  1  0/278 (0.00%)  1/272 (0.37%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer  1  0/278 (0.00%)  1/272 (0.37%) 
Renal cell carcinoma  1  0/278 (0.00%)  1/272 (0.37%) 
Psychiatric disorders     
Depression  1  2/278 (0.72%)  0/272 (0.00%) 
Bipolar disorder  1  1/278 (0.36%)  0/272 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumothorax  1  0/278 (0.00%)  1/272 (0.37%) 
Pulmonary embolism  1  0/278 (0.00%)  1/272 (0.37%) 
Pulmonary oedema  1  0/278 (0.00%)  1/272 (0.37%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 14.0.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
onabotulinumtoxinA Placebo/onabotulinumtoxinA
Affected / at Risk (%) Affected / at Risk (%)
Total   155/278 (55.76%)   79/272 (29.04%) 
Infections and infestations     
Urinary tract infection  1  68/278 (24.46%)  25/272 (9.19%) 
Bacteriuria  1  23/278 (8.27%)  10/272 (3.68%) 
Renal and urinary disorders     
Dysuria  1  40/278 (14.39%)  27/272 (9.93%) 
Urinary retention  1  16/278 (5.76%)  1/272 (0.37%) 
Haematuria  1 [1]  8/278 (2.88%)  16/272 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 14.0.
[1]
Event not treatment related
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00910845    
Other Study ID Numbers: 191622-095
First Submitted: May 28, 2009
First Posted: June 1, 2009
Results First Submitted: January 29, 2013
Results First Posted: March 5, 2013
Last Update Posted: March 5, 2013