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Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

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ClinicalTrials.gov Identifier: NCT00910520
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 548
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 277 271
Completed 257 247
Not Completed 20 24
Period Title: Treatment Cycle 2
Started 163 [1] 223 [1]
Completed 156 215
Not Completed 7 8
[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 277 271 548
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 277 participants 271 participants 548 participants
< 40 years 38 24 62
Between 40 and 64 years 115 139 254
Between 65 and 74 years 82 73 155
≥ 75 years 42 35 77
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 277 participants 271 participants 548 participants
Female
244
  88.1%
229
  84.5%
473
  86.3%
Male
33
  11.9%
42
  15.5%
75
  13.7%
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 277 271
Mean (Standard Deviation)
Unit of Measure: Incontinence episodes
Baseline 5.52  (3.753) 5.70  (3.858)
Change from Baseline at Week 12 -2.95  (3.576) -1.03  (3.004)
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 277 271
Mean (Standard Deviation)
Unit of Measure: micturition episodes
Baseline 12.01  (4.007) 11.77  (3.648)
Change from Baseline at Week 12 -2.56  (3.351) -0.83  (2.523)
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 277 271
Mean (Standard Deviation)
Unit of Measure: milliliters
Baseline 144.2  (57.54) 152.5  (59.27)
Change from Baseline at Week 12 43.0  (65.27) 12.6  (52.01)
Time Frame [Not Specified]
Adverse Event Reporting Description The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that 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   17/274 (6.20%)   15/270 (5.56%) 
Blood and lymphatic system disorders     
Iron deficiency anaemia  1  1/274 (0.36%)  0/270 (0.00%) 
Cardiac disorders     
Angina pectoris  1  1/274 (0.36%)  2/270 (0.74%) 
Acute myocardial infarction  1  1/274 (0.36%)  0/270 (0.00%) 
Atrial fibrillation  1  0/274 (0.00%)  1/270 (0.37%) 
Myocardial ischaemia  1  0/274 (0.00%)  1/270 (0.37%) 
Gastrointestinal disorders     
Ileus  1  0/274 (0.00%)  1/270 (0.37%) 
Lower gastrointestinal haemorrhage  1  0/274 (0.00%)  1/270 (0.37%) 
General disorders     
Chest pain  1  0/274 (0.00%)  1/270 (0.37%) 
Pelvic mass  1  0/274 (0.00%)  1/270 (0.37%) 
Hepatobiliary disorders     
Cholecystitis  1  0/274 (0.00%)  1/270 (0.37%) 
Infections and infestations     
Appendicitis  1  1/274 (0.36%)  0/270 (0.00%) 
Injury, poisoning and procedural complications     
Femur fracture  1  1/274 (0.36%)  0/270 (0.00%) 
Spinal compression fracture  1  1/274 (0.36%)  0/270 (0.00%) 
Tendon rupture  1  1/274 (0.36%)  0/270 (0.00%) 
Foot fracture  1  0/274 (0.00%)  1/270 (0.37%) 
Investigations     
Oxygen saturation decreased  1  0/274 (0.00%)  1/270 (0.37%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  1/274 (0.36%)  2/270 (0.74%) 
Arthralgia  1  1/274 (0.36%)  0/270 (0.00%) 
Foot deformity  1  1/274 (0.36%)  0/270 (0.00%) 
Arthropathy  1  0/274 (0.00%)  1/270 (0.37%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous cell carcinoma  1  1/274 (0.36%)  0/270 (0.00%) 
Breast cancer  1  0/274 (0.00%)  1/270 (0.37%) 
Endometrial cancer  1  0/274 (0.00%)  1/270 (0.37%) 
Nervous system disorders     
Cerebrovascular accident  1  1/274 (0.36%)  0/270 (0.00%) 
Renal and urinary disorders     
Urinary retention  1  2/274 (0.73%)  0/270 (0.00%) 
Haematuria  1  1/274 (0.36%)  0/270 (0.00%) 
Reproductive system and breast disorders     
Vaginal disorder  1  0/274 (0.00%)  1/270 (0.37%) 
Vascular disorders     
Arterial thrombosis  1  1/274 (0.36%)  0/270 (0.00%) 
Hypertension  1  1/274 (0.36%)  0/270 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (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   115/274 (41.97%)   47/270 (17.41%) 
Infections and infestations     
Urinary tract infection  1  66/274 (24.09%)  26/270 (9.63%) 
Bacteriuria  1  17/274 (6.20%)  9/270 (3.33%) 
Renal and urinary disorders     
Dysuria  1  16/274 (5.84%)  11/270 (4.07%) 
Urinary retention  1  16/274 (5.84%)  1/270 (0.37%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
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 ext:
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00910520    
Other Study ID Numbers: 191622-520
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