Trial Outcomes & Findings for A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence (NCT NCT01767519)
NCT ID: NCT01767519
Last Updated: 2019-04-23
Results Overview
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
356 participants
Primary outcome timeframe
Study Baseline, Week 12
Results posted on
2019-04-23
Participant Flow
Participant Flow is for Treatment cycle 1, which is the double-blind portion of the study and includes the primary timepoint.
Participant milestones
| Measure |
BOTOX®
Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
|
Solifenacin
Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
Placebo
Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
|---|---|---|---|
|
Overall Study
STARTED
|
145
|
151
|
60
|
|
Overall Study
COMPLETED
|
131
|
138
|
55
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
5
|
Reasons for withdrawal
| Measure |
BOTOX®
Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
|
Solifenacin
Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
Placebo
Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
|---|---|---|---|
|
Overall Study
Other Reasons
|
4
|
4
|
2
|
|
Overall Study
Protocol Violation
|
0
|
3
|
0
|
|
Overall Study
Personal Reasons
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
5
|
5
|
1
|
Baseline Characteristics
A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence
Baseline characteristics by cohort
| Measure |
BOTOX®
n=145 Participants
Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
|
Solifenacin
n=151 Participants
Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
Placebo
n=60 Participants
Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
Total
n=356 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<65 years
|
77 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
190 Participants
n=4 Participants
|
|
Age, Customized
≥65 years
|
68 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
123 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
308 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Study Baseline, Week 12Population: Intent-to-Treat: includes all patients according to the group to which they are randomized
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Outcome measures
| Measure |
BOTOX®
n=145 Participants
Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
|
Solifenacin
n=151 Participants
Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
Placebo
n=60 Participants
Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
|---|---|---|---|
|
Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1
Study Baseline
|
4.86 Incontinence Episodes
Standard Deviation 3.206
|
5.23 Incontinence Episodes
Standard Deviation 3.333
|
4.38 Incontinence Episodes
Standard Deviation 2.485
|
|
Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1
Change from Study Baseline at Week 12
|
-3.10 Incontinence Episodes
Standard Deviation 2.799
|
-2.66 Incontinence Episodes
Standard Deviation 3.059
|
-0.98 Incontinence Episodes
Standard Deviation 2.417
|
PRIMARY outcome
Timeframe: Study Baseline, Week 12Population: Intent-to-Treat: includes all patients according to the group to which they are randomized
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period and compared to baseline to determine 100% reduction in episodes.
Outcome measures
| Measure |
BOTOX®
n=145 Participants
Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
|
Solifenacin
n=151 Participants
Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
Placebo
n=60 Participants
Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
|---|---|---|---|
|
Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1
|
33.8 Percentage of Patients
|
24.5 Percentage of Patients
|
11.7 Percentage of Patients
|
SECONDARY outcome
Timeframe: Week 12Population: Intent-to-Treat: includes all patients according to the group to which they are randomized
A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing 'greatly improved' or 'improved.'
Outcome measures
| Measure |
BOTOX®
n=145 Participants
Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
|
Solifenacin
n=151 Participants
Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
Placebo
n=60 Participants
Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
|---|---|---|---|
|
Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1
|
71.3 Percentage of Patients
Interval 62.9 to 78.7
|
74.0 Percentage of Patients
Interval 66.1 to 80.9
|
44.8 Percentage of Patients
Interval 31.7 to 58.5
|
SECONDARY outcome
Timeframe: Study Baseline, Week 12Population: Intent-to-Treat: includes all patients according to the group to which they are randomized
The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Outcome measures
| Measure |
BOTOX®
n=145 Participants
Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
|
Solifenacin
n=151 Participants
Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
Placebo
n=60 Participants
Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
|---|---|---|---|
|
Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1
Study Baseline
|
10.74 Micturition Episodes
Standard Deviation 2.520
|
10.40 Micturition Episodes
Standard Deviation 2.665
|
10.18 Micturition Episodes
Standard Deviation 2.491
|
|
Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1
Change from Study Baseline at Wk 12 (N=135,144,57)
|
-2.40 Micturition Episodes
Standard Deviation 2.827
|
-2.03 Micturition Episodes
Standard Deviation 2.833
|
-0.87 Micturition Episodes
Standard Deviation 2.413
|
SECONDARY outcome
Timeframe: Study Baseline, Week 12Population: Intent-to-Treat: includes all patients according to the group to which they are randomized
Nocturia episodes are measured over a 3 day diary prior to each visit in Treatment Cycle 1. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Outcome measures
| Measure |
BOTOX®
n=145 Participants
Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
|
Solifenacin
n=151 Participants
Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
Placebo
n=60 Participants
Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
|---|---|---|---|
|
Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1
Study Baseline
|
2.03 Nocturia Episodes
Standard Deviation 1.159
|
2.04 Nocturia Episodes
Standard Deviation 1.083
|
1.98 Nocturia Episodes
Standard Deviation 0.937
|
|
Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1
Change from Study Baseline at Wk 12 (N=135,144,57)
|
-0.54 Nocturia Episodes
Standard Deviation 1.195
|
-0.49 Nocturia Episodes
Standard Deviation 1.133
|
-0.23 Nocturia Episodes
Standard Deviation 1.091
|
SECONDARY outcome
Timeframe: Study Baseline, Week 12Population: Intent-to-Treat: includes all patients according to the group to which they are randomized
The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the role limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Outcome measures
| Measure |
BOTOX®
n=145 Participants
Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
|
Solifenacin
n=150 Participants
Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
Placebo
n=59 Participants
Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
|---|---|---|---|
|
Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1
Study Baseline
|
76.09 Scores on a Scale
Standard Deviation 24.281 • Interval 61.1 to 77.2
|
72.11 Scores on a Scale
Standard Deviation 26.581 • Interval 51.5 to 68.0
|
81.36 Scores on a Scale
Standard Deviation 20.781 • Interval 39.0 to 66.0
|
|
Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1
Change from Study Baseline at Wk 12 (N=135,145,57)
|
-30.0 Scores on a Scale
Standard Deviation 33.259 • Interval 52.0 to 69.0
|
-23.79 Scores on a Scale
Standard Deviation 31.899 • Interval 49.5 to 66.1
|
-17.25 Scores on a Scale
Standard Deviation 29.033 • Interval 29.1 to 55.9
|
SECONDARY outcome
Timeframe: Study Baseline, Week 12Population: Intent-to-Treat: includes all patients according to the group to which they are randomized
The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the social limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Outcome measures
| Measure |
BOTOX®
n=145 Participants
Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
|
Solifenacin
n=150 Participants
Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
Placebo
n=59 Participants
Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
|---|---|---|---|
|
Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1
Study Baseline
|
59.66 Scores on a Scale
Standard Deviation 21.442 • Interval 61.1 to 77.2
|
56.22 Scores on a Scale
Standard Deviation 22.708 • Interval 51.5 to 68.0
|
62.57 Scores on a Scale
Standard Deviation 22.551 • Interval 39.0 to 66.0
|
|
Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1
Change from Study Baseline at Wk 12 (N=135,145,57)
|
-13.46 Scores on a Scale
Standard Deviation 21.906 • Interval 52.0 to 69.0
|
-12.70 Scores on a Scale
Standard Deviation 21.361 • Interval 49.5 to 66.1
|
-7.60 Scores on a Scale
Standard Deviation 21.667 • Interval 29.1 to 55.9
|
Adverse Events
BOTOX®
Serious events: 6 serious events
Other events: 57 other events
Deaths: 0 deaths
Solifenacin
Serious events: 6 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BOTOX®
n=145 participants at risk
Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
|
Solifenacin
n=147 participants at risk
Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
Placebo
n=60 participants at risk
Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.69%
1/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
|
Cardiac disorders
Bradycardia
|
0.69%
1/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.69%
1/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.68%
1/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.69%
1/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
1.4%
2/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.69%
1/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.68%
1/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
|
Nervous system disorders
Migraine
|
0.69%
1/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
1.7%
1/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
|
Psychiatric disorders
Anxiety
|
0.69%
1/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
|
Psychiatric disorders
Polysubstance dependence
|
0.00%
0/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.68%
1/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
1.7%
1/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/123
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.76%
1/131
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/51
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
Other adverse events
| Measure |
BOTOX®
n=145 participants at risk
Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
|
Solifenacin
n=147 participants at risk
Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
Placebo
n=60 participants at risk
Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
|
|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
2.8%
4/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
8.2%
12/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
|
Infections and infestations
Urinary tract infection
|
25.5%
37/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
10.2%
15/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
10.0%
6/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
|
Infections and infestations
Bacteriuria
|
7.6%
11/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
9.5%
14/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
5.0%
3/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
|
Investigations
Residual urine volume
|
6.9%
10/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
1.7%
1/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
|
Renal and urinary disorders
Urinary retention
|
6.9%
10/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.68%
1/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
|
Renal and urinary disorders
Dysuria
|
4.1%
6/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
5.4%
8/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
3.3%
2/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
2/145
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
1.4%
2/147
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
|
5.0%
3/60
The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events 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