Trial Outcomes & Findings for Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence (NCT NCT00910520)
NCT ID: NCT00910520
Last Updated: 2013-03-05
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
548 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2013-03-05
Participant Flow
Participant milestones
| Measure |
onabotulinumtoxinA
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/onabotulinumtoxinA
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).
|
|---|---|---|
|
Treatment Cycle 1
STARTED
|
277
|
271
|
|
Treatment Cycle 1
COMPLETED
|
257
|
247
|
|
Treatment Cycle 1
NOT COMPLETED
|
20
|
24
|
|
Treatment Cycle 2
STARTED
|
163
|
223
|
|
Treatment Cycle 2
COMPLETED
|
156
|
215
|
|
Treatment Cycle 2
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
Baseline characteristics by cohort
| Measure |
onabotulinumtoxinA
n=277 Participants
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/onabotulinumtoxinA
n=271 Participants
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
n=548 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 40 years
|
38 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Age, Customized
Between 40 and 64 years
|
115 Participants
n=99 Participants
|
139 Participants
n=107 Participants
|
254 Participants
n=206 Participants
|
|
Age, Customized
Between 65 and 74 years
|
82 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
155 Participants
n=206 Participants
|
|
Age, Customized
≥ 75 years
|
42 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
244 Participants
n=99 Participants
|
229 Participants
n=107 Participants
|
473 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat population included all randomized patients.
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).
Outcome measures
| Measure |
onabotulinumtoxinA
n=277 Participants
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/onabotulinumtoxinA
n=271 Participants
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).
|
|---|---|---|
|
Change From Baseline in Number of Daily Episodes of Urinary Incontinence
Baseline
|
5.52 Incontinence episodes
Standard Deviation 3.753
|
5.70 Incontinence episodes
Standard Deviation 3.858
|
|
Change From Baseline in Number of Daily Episodes of Urinary Incontinence
Change from Baseline at Week 12
|
-2.95 Incontinence episodes
Standard Deviation 3.576
|
-1.03 Incontinence episodes
Standard Deviation 3.004
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat population included all randomized patients.
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).
Outcome measures
| Measure |
onabotulinumtoxinA
n=277 Participants
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/onabotulinumtoxinA
n=271 Participants
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).
|
|---|---|---|
|
Change From Baseline in Number of Daily Micturition Episodes
Baseline
|
12.01 micturition episodes
Standard Deviation 4.007
|
11.77 micturition episodes
Standard Deviation 3.648
|
|
Change From Baseline in Number of Daily Micturition Episodes
Change from Baseline at Week 12
|
-2.56 micturition episodes
Standard Deviation 3.351
|
-0.83 micturition episodes
Standard Deviation 2.523
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat population included all randomized patients.
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).
Outcome measures
| Measure |
onabotulinumtoxinA
n=277 Participants
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/onabotulinumtoxinA
n=271 Participants
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).
|
|---|---|---|
|
Change From Baseline in Volume Voided Per Micturition
Change from Baseline at Week 12
|
43.0 milliliters
Standard Deviation 65.27
|
12.6 milliliters
Standard Deviation 52.01
|
|
Change From Baseline in Volume Voided Per Micturition
Baseline
|
144.2 milliliters
Standard Deviation 57.54
|
152.5 milliliters
Standard Deviation 59.27
|
Adverse Events
onabotulinumtoxinA
Serious events: 17 serious events
Other events: 115 other events
Deaths: 0 deaths
Placebo/onabotulinumtoxinA
Serious events: 15 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
onabotulinumtoxinA
n=274 participants at risk
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/onabotulinumtoxinA
n=270 participants at risk
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).
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.36%
1/274
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.
|
0.00%
0/270
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.
|
|
Cardiac disorders
Angina pectoris
|
0.36%
1/274
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.
|
0.74%
2/270
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.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.36%
1/274
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.
|
0.00%
0/270
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.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/274
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.
|
0.37%
1/270
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.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/274
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.
|
0.37%
1/270
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.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/274
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.
|
0.37%
1/270
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.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/274
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.
|
0.37%
1/270
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.
|
|
General disorders
Chest pain
|
0.00%
0/274
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.
|
0.37%
1/270
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.
|
|
General disorders
Pelvic mass
|
0.00%
0/274
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.
|
0.37%
1/270
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.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/274
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.
|
0.37%
1/270
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.
|
|
Infections and infestations
Appendicitis
|
0.36%
1/274
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.
|
0.00%
0/270
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.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.36%
1/274
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.
|
0.00%
0/270
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.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.36%
1/274
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.
|
0.00%
0/270
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.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.36%
1/274
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.
|
0.00%
0/270
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.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/274
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.
|
0.37%
1/270
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.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/274
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.
|
0.37%
1/270
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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.36%
1/274
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.
|
0.74%
2/270
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.36%
1/274
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.
|
0.00%
0/270
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.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.36%
1/274
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.
|
0.00%
0/270
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.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/274
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.
|
0.37%
1/270
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.36%
1/274
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.
|
0.00%
0/270
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/274
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.
|
0.37%
1/270
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/274
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.
|
0.37%
1/270
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.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.36%
1/274
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.
|
0.00%
0/270
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.
|
|
Renal and urinary disorders
Urinary retention
|
0.73%
2/274
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.
|
0.00%
0/270
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.
|
|
Renal and urinary disorders
Haematuria
|
0.36%
1/274
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.
|
0.00%
0/270
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.
|
|
Reproductive system and breast disorders
Vaginal disorder
|
0.00%
0/274
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.
|
0.37%
1/270
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.
|
|
Vascular disorders
Arterial thrombosis
|
0.36%
1/274
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.
|
0.00%
0/270
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.
|
|
Vascular disorders
Hypertension
|
0.36%
1/274
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.
|
0.00%
0/270
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.
|
Other adverse events
| Measure |
onabotulinumtoxinA
n=274 participants at risk
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/onabotulinumtoxinA
n=270 participants at risk
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).
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
24.1%
66/274
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.
|
9.6%
26/270
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.
|
|
Infections and infestations
Bacteriuria
|
6.2%
17/274
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.
|
3.3%
9/270
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.
|
|
Renal and urinary disorders
Dysuria
|
5.8%
16/274
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.
|
4.1%
11/270
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.
|
|
Renal and urinary disorders
Urinary retention
|
5.8%
16/274
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.
|
0.37%
1/270
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER