Trial Outcomes & Findings for Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life (NCT NCT00573508)
NCT ID: NCT00573508
Last Updated: 2010-10-05
Results Overview
The OAB-q is used to assess how much a patient is bothered by OAB symptoms \& the impact of these symptoms on the patient's Health Related Quality of Life(HRQL). It is a patient administered tool comprised of 33 items, where the first 8 define symptom bother with raw score being converted to a scale of 0 to 100. Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment - Baseline.
COMPLETED
PHASE4
768 participants
Baseline and 12 Weeks
2010-10-05
Participant Flow
Participant milestones
| Measure |
Placebo
Matching placebo tablet taken once daily
|
Solifenacin Succinate
5mg or 10mg tablet taken once daily
|
|---|---|---|
|
Overall Study
STARTED
|
382
|
386
|
|
Overall Study
Full Analysis Set (FAS)
|
374
|
377
|
|
Overall Study
COMPLETED
|
318
|
345
|
|
Overall Study
NOT COMPLETED
|
64
|
41
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life
Baseline characteristics by cohort
| Measure |
Placebo
n=382 Participants
Matching placebo tablet taken once daily
|
Solifenacin Succinate
n=386 Participants
5mg or 10mg tablet taken once daily
|
Total
n=768 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.4 years
STANDARD_DEVIATION 12.36 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 13.44 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 12.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
321 Participants
n=5 Participants
|
311 Participants
n=7 Participants
|
632 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
333 participants
n=5 Participants
|
347 participants
n=7 Participants
|
680 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
30 participants
n=5 Participants
|
24 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian-Other Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit. The number of participants per arm is consistent for all categories / rows of the data table.
The OAB-q is used to assess how much a patient is bothered by OAB symptoms \& the impact of these symptoms on the patient's Health Related Quality of Life(HRQL). It is a patient administered tool comprised of 33 items, where the first 8 define symptom bother with raw score being converted to a scale of 0 to 100. Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment - Baseline.
Outcome measures
| Measure |
Placebo
n=374 Participants
Matching placebo tablet taken once daily
|
Solifenacin Succinate
n=377 Participants
5mg or 10mg tablet taken once daily
|
|---|---|---|
|
Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score
Baseline
|
57.9 OAB-q Score
Standard Deviation 18.18
|
58.2 OAB-q Score
Standard Deviation 18.75
|
|
Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score
End of Treatment
|
37.5 OAB-q Score
Standard Deviation 22.54
|
28.3 OAB-q Score
Standard Deviation 20.36
|
|
Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score
Change at End of Treatment
|
-20.4 OAB-q Score
Standard Deviation 21.72
|
-29.9 OAB-q Score
Standard Deviation 22.64
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8 and Week 12Population: Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles.
The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where the first 8 items define symptom bother with raw score being converted to a scale of 0 to 100. Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement. Change is calculated as Actual Data for each timepoint - Baseline.
Outcome measures
| Measure |
Placebo
n=374 Participants
Matching placebo tablet taken once daily
|
Solifenacin Succinate
n=377 Participants
5mg or 10mg tablet taken once daily
|
|---|---|---|
|
Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score
Week 12 (N=318; 339)
|
36.0 OAB-q Score
Standard Deviation 21.91
|
27.6 OAB-q Score
Standard Deviation 20.32
|
|
Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score
Baseline ( N= 374 ; 377)
|
57.9 OAB-q Score
Standard Deviation 18.18
|
58.2 OAB-q Score
Standard Deviation 18.75
|
|
Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score
Week 4 (N=371; 370)
|
41.6 OAB-q Score
Standard Deviation 21.04
|
35.5 OAB-q Score
Standard Deviation 20.77
|
|
Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score
Change at Week 4 (N=371; 370)
|
-16.4 OAB-q Score
Standard Deviation 19.33
|
-22.6 OAB-q Score
Standard Deviation 20.55
|
|
Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score
Week 8 (N=342; 356)
|
37.0 OAB-q Score
Standard Deviation 21.86
|
29.8 OAB-q Score
Standard Deviation 20.23
|
|
Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score
Change at Week 8 (N=342; 356)
|
-21.0 OAB-q Score
Standard Deviation 20.64
|
-28.9 OAB-q Score
Standard Deviation 22.11
|
|
Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score
Change at Week 12 (N=318; 339)
|
-21.7 OAB-q Score
Standard Deviation 21.52
|
-30.9 OAB-q Score
Standard Deviation 22.29
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8 and Week 12Population: Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles.
The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where items 9 - 33 define HRQL with raw score being converted to a scale of 0 to 100. Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement. Change is calculated as Actual Data for each time point - Baseline.
Outcome measures
| Measure |
Placebo
n=374 Participants
Matching placebo tablet taken once daily
|
Solifenacin Succinate
n=377 Participants
5mg or 10mg tablet taken once daily
|
|---|---|---|
|
Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score
Baseline (N= 374 ; 377)
|
57.8 OAB-q HRQL Total Score
Standard Deviation 21.34
|
56.4 OAB-q HRQL Total Score
Standard Deviation 22.10
|
|
Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score
Week 4 (N=371; 370)
|
71.4 OAB-q HRQL Total Score
Standard Deviation 21.42
|
76.0 OAB-q HRQL Total Score
Standard Deviation 20.81
|
|
Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score
Change at Week 4(N=371; 370)
|
13.5 OAB-q HRQL Total Score
Standard Deviation 17.92
|
19.3 OAB-q HRQL Total Score
Standard Deviation 19.43
|
|
Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score
Week 8 (N=342; 356)
|
75.2 OAB-q HRQL Total Score
Standard Deviation 21.06
|
80.5 OAB-q HRQL Total Score
Standard Deviation 19.94
|
|
Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score
Change at Week 8 (N=342; 356)
|
17.3 OAB-q HRQL Total Score
Standard Deviation 19.00
|
24.4 OAB-q HRQL Total Score
Standard Deviation 21.35
|
|
Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score
Week 12 (N=318; 339)
|
76.7 OAB-q HRQL Total Score
Standard Deviation 20.53
|
82.2 OAB-q HRQL Total Score
Standard Deviation 19.64
|
|
Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score
Change at Week 12(N=318; 339)
|
18.0 OAB-q HRQL Total Score
Standard Deviation 19.39
|
25.8 OAB-q HRQL Total Score
Standard Deviation 22.30
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.
The PPBC is a validated, global assessment tool using a 6-point Likert scale which requires patients to assess their bladder condition by selecting one of the following responses: 1=Does not cause me any problem at all; 2=Cause me some very minor problems; 3=Causes me some minor problems; 4=Causes me (some) moderate problems; 5=Causes me severe problems; 6=Causes me many severe problems Improvement is defined by any reduction in PPBC score. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment (EOT) - Baseline
Outcome measures
| Measure |
Placebo
n=362 Participants
Matching placebo tablet taken once daily
|
Solifenacin Succinate
n=368 Participants
5mg or 10mg tablet taken once daily
|
|---|---|---|
|
Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC)
No Improvement from Baseline to End of Treatment
|
131 Participants
|
90 Participants
|
|
Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC)
Improvement from Baseline to End of Treatment
|
231 Participants
|
278 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: The number assessed included all participants who completed the BSW questionnaire at baseline visit (visit 2) and end of treatment (visit 5/early withdrawal). A few patients who completed the BSW Questionnaire did not adequately complete the " Benefits" Section and therefore are considered 'N/A' for that Section.
The BSW questionnaire is a validated instrument that can be used to assess patient satisfaction with antimuscarinic agents for OAB. It is designed to capture the patient's perception of the effect of treatment in terms of relative benefit, patient satisfaction, and patient intention or willingness to continue on therapy.
Outcome measures
| Measure |
Placebo
n=316 Participants
Matching placebo tablet taken once daily
|
Solifenacin Succinate
n=335 Participants
5mg or 10mg tablet taken once daily
|
|---|---|---|
|
Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire
Benefit from Treatment - No
|
115 Participants
|
53 Participants
|
|
Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire
Satisfied with Treatment - Yes
|
187 Participants
|
269 Participants
|
|
Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire
Benefit from Treatment - Little
|
90 Participants
|
80 Participants
|
|
Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire
Benefit from Treatment - Much
|
109 Participants
|
196 Participants
|
|
Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire
Benifit from Treatment - N/A
|
2 Participants
|
6 Participants
|
|
Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire
Satisfied with Treatment - No
|
129 Participants
|
66 Participants
|
|
Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire
Willingness to Continue - No
|
128 Participants
|
71 Participants
|
|
Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire
Willingness to Continue - Yes
|
188 Participants
|
264 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8 and Week 12Population: Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit. Number of participants analyzed per arm represents FAS. The numbers of participants for each visit/sub domain are noted in the category titles.
The OAB-q is used to assess how much a patient is bothered by OAB symptoms \& the impact on the patient's HRQL. It is comprised of 33 items, with raw scores for each sub-domain being converted to a scale of 0 to 100. Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement. Change is calculated End of Treatment (EOT) for each sub-domain - Baseline.
Outcome measures
| Measure |
Placebo
n=374 Participants
Matching placebo tablet taken once daily
|
Solifenacin Succinate
n=377 Participants
5mg or 10mg tablet taken once daily
|
|---|---|---|
|
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
Concern- Change at Week 4 (N=371; 370)
|
15.8 OAB-q HRQL Sub Domain Score
Standard Deviation 21.58
|
22.4 OAB-q HRQL Sub Domain Score
Standard Deviation 23.37
|
|
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
Coping- Baseline (N= 374 ; 377)
|
53.7 OAB-q HRQL Sub Domain Score
Standard Deviation 25.78
|
52.2 OAB-q HRQL Sub Domain Score
Standard Deviation 26.76
|
|
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
Coping- Change at Week 4 (N=371; 370)
|
14.9 OAB-q HRQL Sub Domain Score
Standard Deviation 21.55
|
22.2 OAB-q HRQL Sub Domain Score
Standard Deviation 22.20
|
|
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
Coping- Change at Week 8 (N=342; 356)
|
18.9 OAB-q HRQL Sub Domain Score
Standard Deviation 21.97
|
27.0 OAB-q HRQL Sub Domain Score
Standard Deviation 24.81
|
|
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
Coping- Change at Week 12 (N=318; 339)
|
19.9 OAB-q HRQL Sub Domain Score
Standard Deviation 22.56
|
28.8 OAB-q HRQL Sub Domain Score
Standard Deviation 25.22
|
|
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
Concern- Baseline (N= 374 ; 377)
|
52.0 OAB-q HRQL Sub Domain Score
Standard Deviation 25.49
|
51.9 OAB-q HRQL Sub Domain Score
Standard Deviation 26.06
|
|
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
Concern- Change at Week 8 (N=342; 356)
|
19.8 OAB-q HRQL Sub Domain Score
Standard Deviation 22.87
|
28.4 OAB-q HRQL Sub Domain Score
Standard Deviation 25.64
|
|
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
Concern- Change at Week 12 (N=318; 339)
|
20.9 OAB-q HRQL Sub Domain Score
Standard Deviation 23.10
|
29.9 OAB-q HRQL Sub Domain Score
Standard Deviation 26.32
|
|
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
Sleep- Baseline (N= 374 ; 377)
|
51.3 OAB-q HRQL Sub Domain Score
Standard Deviation 25.78
|
47.3 OAB-q HRQL Sub Domain Score
Standard Deviation 27.55
|
|
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
Sleep- Change at Week 4 (N=371; 370)
|
13.9 OAB-q HRQL Sub Domain Score
Standard Deviation 22.91
|
19.3 OAB-q HRQL Sub Domain Score
Standard Deviation 23.68
|
|
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
Sleep- Change at Week 8 (N=342; 356)
|
18.7 OAB-q HRQL Sub Domain Score
Standard Deviation 24.46
|
26.2 OAB-q HRQL Sub Domain Score
Standard Deviation 24.94
|
|
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
Sleep- Change at Week 12 (N=318; 339)
|
19.0 OAB-q HRQL Sub Domain Score
Standard Deviation 24.65
|
27.5 OAB-q HRQL Sub Domain Score
Standard Deviation 26.56
|
|
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
Social- Baseline (N= 374 ; 377)
|
78.9 OAB-q HRQL Sub Domain Score
Standard Deviation 23.13
|
78.7 OAB-q HRQL Sub Domain Score
Standard Deviation 23.56
|
|
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
Social- Change at Week 4 (N=371; 370)
|
7.8 OAB-q HRQL Sub Domain Score
Standard Deviation 16.51
|
10.3 OAB-q HRQL Sub Domain Score
Standard Deviation 18.66
|
|
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
Social- Change at Week 8 (N=340; 356)
|
9.4 OAB-q HRQL Sub Domain Score
Standard Deviation 16.49
|
13.1 OAB-q HRQL Sub Domain Score
Standard Deviation 19.65
|
|
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
Social- Change at Week 12 (N=318; 339)
|
10.0 OAB-q HRQL Sub Domain Score
Standard Deviation 17.81
|
13.7 OAB-q HRQL Sub Domain Score
Standard Deviation 21.38
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Population is full analysis set (FAS): all randomized patients who took at least 1 dose of double-blind study drug \& had an OAB-q assessment at both baseline \& at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint / parameter are noted in the category titles.
The WPAI is a tool used to evaluate the effect of solifenacin succinate on a patient's overall satisfaction \& quality of life, and included 6 questions regarding the effect that bladder condition had on ability to perform work-related functions \& carry out daily activities over the past 4 weeks. The scores were converted to percentages for reporting. A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change from baseline is based on the ANCOVA model after adjusting baseline value \& center.
Outcome measures
| Measure |
Placebo
n=374 Participants
Matching placebo tablet taken once daily
|
Solifenacin Succinate
n=377 Participants
5mg or 10mg tablet taken once daily
|
|---|---|---|
|
Change From Baseline in Work Productivity Assessment Index (WPAI)
% impairment while working- Baseline(N=203;194)
|
27.5 Percentage of indicated parameter
Standard Deviation 25.93
|
27.6 Percentage of indicated parameter
Standard Deviation 25.72
|
|
Change From Baseline in Work Productivity Assessment Index (WPAI)
% impairment while working- EOT (N=193;197)
|
18.4 Percentage of indicated parameter
Standard Deviation 21.11
|
13.2 Percentage of indicated parameter
Standard Deviation 18.19
|
|
Change From Baseline in Work Productivity Assessment Index (WPAI)
% impairment working-Change at EOT(N=172;175)
|
-8.7 Percentage of indicated parameter
Standard Deviation 23.03
|
-14.6 Percentage of indicated parameter
Standard Deviation 24.09
|
|
Change From Baseline in Work Productivity Assessment Index (WPAI)
% overall work impairment- Baseline (N=174;175)
|
28.5 Percentage of indicated parameter
Standard Deviation 25.77
|
28.2 Percentage of indicated parameter
Standard Deviation 25.29
|
|
Change From Baseline in Work Productivity Assessment Index (WPAI)
% work time missed- Baseline (N=175;175)
|
1.4 Percentage of indicated parameter
Standard Deviation 8.60
|
1.1 Percentage of indicated parameter
Standard Deviation 3.54
|
|
Change From Baseline in Work Productivity Assessment Index (WPAI)
% work time missed- EOT (N=161;157)
|
0.8 Percentage of indicated parameter
Standard Deviation 5.85
|
0.5 Percentage of indicated parameter
Standard Deviation 2.04
|
|
Change From Baseline in Work Productivity Assessment Index (WPAI)
% work time missed- Change at EOT (N=145;142)
|
0.1 Percentage of indicated parameter
Standard Deviation 4.26
|
-0.5 Percentage of indicated parameter
Standard Deviation 3.34
|
|
Change From Baseline in Work Productivity Assessment Index (WPAI)
% overall work impairment- EOT (N=161;157)
|
20.8 Percentage of indicated parameter
Standard Deviation 21.81
|
14.1 Percentage of indicated parameter
Standard Deviation 18.67
|
|
Change From Baseline in Work Productivity Assessment Index (WPAI)
%overall work impairment-Change at EOT(N=145;142)
|
-8.2 Percentage of indicated parameter
Standard Deviation 22.59
|
-12.9 Percentage of indicated parameter
Standard Deviation 23.00
|
|
Change From Baseline in Work Productivity Assessment Index (WPAI)
%activity impairment- Baseline (N=368;375)
|
38.6 Percentage of indicated parameter
Standard Deviation 28.36
|
37.3 Percentage of indicated parameter
Standard Deviation 27.44
|
|
Change From Baseline in Work Productivity Assessment Index (WPAI)
% activity impairment- EOT (N=357;362)
|
23.4 Percentage of indicated parameter
Standard Deviation 23.17
|
19.2 Percentage of indicated parameter
Standard Deviation 22.32
|
|
Change From Baseline in Work Productivity Assessment Index (WPAI)
% activity impairment- Change at EOT(N=351;360)
|
-14.7 Percentage of indicated parameter
Standard Deviation 25.46
|
-18.1 Percentage of indicated parameter
Standard Deviation 26.26
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Population is full analysis set(FAS):all randomized patients who took at least 1 dose of double-blind study medication \& had an assessment in OAB-q at both baseline \& at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint/ parameter are noted in the category titles.
MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life.The tool included questions concerning the effect of the patients bladder condition on access to medical care. A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment (EOT) - Baseline
Outcome measures
| Measure |
Placebo
n=374 Participants
Matching placebo tablet taken once daily
|
Solifenacin Succinate
n=377 Participants
5mg or 10mg tablet taken once daily
|
|---|---|---|
|
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
physician office visits- Baseline (N=371; 375)
|
0.5 Number of categorical items
Standard Deviation 1.30
|
0.5 Number of categorical items
Standard Deviation 1.22
|
|
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
physician office visits- EOT (N=362; 366)
|
0.2 Number of categorical items
Standard Deviation 0.62
|
0.2 Number of categorical items
Standard Deviation 0.79
|
|
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
physician office visits- Change at EOT(359; 365)
|
-0.4 Number of categorical items
Standard Deviation 1.29
|
-0.3 Number of categorical items
Standard Deviation 1.23
|
|
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
urinary tract infections-Baseline (N=371; 370)
|
0.1 Number of categorical items
Standard Deviation 0.37
|
0.1 Number of categorical items
Standard Deviation 0.46
|
|
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
urinary tract infections- EOT (N=358; 362)
|
0.1 Number of categorical items
Standard Deviation 0.28
|
0.1 Number of categorical items
Standard Deviation 0.50
|
|
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
urinary tract infections-Change at EOT (355; 356)
|
-0.1 Number of categorical items
Standard Deviation 0.38
|
0.0 Number of categorical items
Standard Deviation 0.57
|
|
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
skin rashes- Baseline (N=367; 368)
|
1.5 Number of categorical items
Standard Deviation 10.52
|
0.3 Number of categorical items
Standard Deviation 1.87
|
|
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
skin rashes- EOT (N=354; 357)
|
1.0 Number of categorical items
Standard Deviation 7.70
|
0.2 Number of categorical items
Standard Deviation 1.83
|
|
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
skin rashes- Change at EOT (N=347; 351)
|
0.0 Number of categorical items
Standard Deviation 8.17
|
-0.1 Number of categorical items
Standard Deviation 1.63
|
|
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
falls- Baseline (N=365; 364)
|
0.2 Number of categorical items
Standard Deviation 0.86
|
0.2 Number of categorical items
Standard Deviation 0.83
|
|
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
falls- EOT (N=356; 358)
|
0.1 Number of categorical items
Standard Deviation 0.72
|
0.5 Number of categorical items
Standard Deviation 5.87
|
|
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
falls- Change at EOT (N=347; 349)
|
-0.1 Number of categorical items
Standard Deviation 0.69
|
0.2 Number of categorical items
Standard Deviation 5.83
|
|
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
pad/diapers used/ week- Baseline (N=371; 375)
|
10.0 Number of categorical items
Standard Deviation 19.17
|
10.4 Number of categorical items
Standard Deviation 20.68
|
|
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
pad/diapers used/ week- EOT (N=360; 364)
|
9.8 Number of categorical items
Standard Deviation 24.07
|
8.3 Number of categorical items
Standard Deviation 40.58
|
|
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
pad/diapers used/ week- Change at EOT(N=357; 362)
|
-0.2 Number of categorical items
Standard Deviation 26.60
|
-2.1 Number of categorical items
Standard Deviation 42.01
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Population is full analysis set(FAS):all randomized patients who took at least 1 dose of double-blind study medication \& had an assessment in OAB-q at both baseline \& at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint/ parameter are noted in the category titles.
MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life. The tool included questions concerning the effect of the patients bladder condition on access to medical care. A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment (EOT) - Baseline
Outcome measures
| Measure |
Placebo
n=374 Participants
Matching placebo tablet taken once daily
|
Solifenacin Succinate
n=377 Participants
5mg or 10mg tablet taken once daily
|
|---|---|---|
|
Change From Baseline in the MCUI Behavior Therapy Stratified
days w/ elec stimulation-Change at EOT(N=337; 345)
|
0.0 Number of Days
Standard Deviation 0.79
|
0.0 Number of Days
Standard Deviation 1.68
|
|
Change From Baseline in the MCUI Behavior Therapy Stratified
days with timed voiding- Baseline (N=364; 365)
|
14.8 Number of Days
Standard Deviation 37.33
|
12.1 Number of Days
Standard Deviation 29.35
|
|
Change From Baseline in the MCUI Behavior Therapy Stratified
days with timed voiding- EOT (N=356; 360)
|
10.3 Number of Days
Standard Deviation 27.07
|
7.4 Number of Days
Standard Deviation 23.13
|
|
Change From Baseline in the MCUI Behavior Therapy Stratified
days with timed voiding-Change at EOT(N=347; 350)
|
-4.0 Number of Days
Standard Deviation 37.38
|
-5.3 Number of Days
Standard Deviation 33.66
|
|
Change From Baseline in the MCUI Behavior Therapy Stratified
days with fluid management-Baseline(N=368; 369)
|
21.3 Number of Days
Standard Deviation 40.07
|
22.1 Number of Days
Standard Deviation 38.38
|
|
Change From Baseline in the MCUI Behavior Therapy Stratified
days with fluid management- EOT (N=355; 366)
|
15.1 Number of Days
Standard Deviation 28.76
|
11.5 Number of Days
Standard Deviation 25.10
|
|
Change From Baseline in the MCUI Behavior Therapy Stratified
days with fluid management-Change at EOT(349; 360)
|
-6.3 Number of Days
Standard Deviation 42.36
|
-11.0 Number of Days
Standard Deviation 40.43
|
|
Change From Baseline in the MCUI Behavior Therapy Stratified
days w/ pelvic floor exercises-Baseline(364; 366)
|
8.5 Number of Days
Standard Deviation 22.17
|
9.2 Number of Days
Standard Deviation 22.78
|
|
Change From Baseline in the MCUI Behavior Therapy Stratified
days w/ pelvic floor exercises- EOT (N=352; 358)
|
12.1 Number of Days
Standard Deviation 56.94
|
5.5 Number of Days
Standard Deviation 17.31
|
|
Change From Baseline in the MCUI Behavior Therapy Stratified
days w/pelvic flr exercises-Change atEOT(344; 349)
|
3.4 Number of Days
Standard Deviation 50.96
|
-3.2 Number of Days
Standard Deviation 19.43
|
|
Change From Baseline in the MCUI Behavior Therapy Stratified
days with biofeedback- Baseline (N=359; 360)
|
0.4 Number of Days
Standard Deviation 5.32
|
0.1 Number of Days
Standard Deviation 0.95
|
|
Change From Baseline in the MCUI Behavior Therapy Stratified
days with biofeedback- EOT (N=352; 358)
|
0.0 Number of Days
Standard Deviation 0.53
|
0.0 Number of Days
Standard Deviation 0.45
|
|
Change From Baseline in the MCUI Behavior Therapy Stratified
days with biofeedback- Change at EOT (N=338; 343)
|
-0.4 Number of Days
Standard Deviation 5.18
|
0.0 Number of Days
Standard Deviation 1.08
|
|
Change From Baseline in the MCUI Behavior Therapy Stratified
days w/ electrical stimulation-Baseline (358; 362)
|
0.0 Number of Days
Standard Deviation 0.63
|
0.1 Number of Days
Standard Deviation 1.58
|
|
Change From Baseline in the MCUI Behavior Therapy Stratified
days w/ electrical stimulation- EOT (N=352; 358)
|
0.0 Number of Days
Standard Deviation 0.43
|
0.1 Number of Days
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Population is full analysis set(FAS): all randomized male patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles.
ICIQ-MLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction \& quality of life. The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms \& impact on sexual quality of life, with a scale of 0 to 12. Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline.
Outcome measures
| Measure |
Placebo
n=60 Participants
Matching placebo tablet taken once daily
|
Solifenacin Succinate
n=71 Participants
5mg or 10mg tablet taken once daily
|
|---|---|---|
|
Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores.
Symptom- Baseline (N=59; 71)
|
3.6 ICIQ-MLUTSsex
Standard Deviation 2.81
|
3.5 ICIQ-MLUTSsex
Standard Deviation 3.01
|
|
Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores.
Symptom- EOT (N=55; 68)
|
3.2 ICIQ-MLUTSsex
Standard Deviation 2.71
|
3.7 ICIQ-MLUTSsex
Standard Deviation 3.00
|
|
Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores.
Symptom- Change at EOT (N=54; 68)
|
-0.1 ICIQ-MLUTSsex
Standard Deviation 1.57
|
0.1 ICIQ-MLUTSsex
Standard Deviation 1.87
|
|
Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores.
Bother- Baseline (N=59; 71)
|
12.1 ICIQ-MLUTSsex
Standard Deviation 11.47
|
11.8 ICIQ-MLUTSsex
Standard Deviation 11.21
|
|
Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores.
Bother- EOT (N=51; 67)
|
10.3 ICIQ-MLUTSsex
Standard Deviation 10.53
|
11.4 ICIQ-MLUTSsex
Standard Deviation 11.17
|
|
Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores.
Bother- Change at EOT (N=50; 67)
|
-1.6 ICIQ-MLUTSsex
Standard Deviation 8.24
|
-0.6 ICIQ-MLUTSsex
Standard Deviation 9.32
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Population is full analysis set(FAS): all randomized female patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles.
ICIQ-FLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction \& quality of life.The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms \& impact on sexual quality of life, with a scale of 0 to 14. Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline.
Outcome measures
| Measure |
Placebo
n=314 Participants
Matching placebo tablet taken once daily
|
Solifenacin Succinate
n=306 Participants
5mg or 10mg tablet taken once daily
|
|---|---|---|
|
Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores.
Symptom- Baseline (N=302; 300)
|
4.9 ICIQ-FLUTSsex
Standard Deviation 3.69
|
5.2 ICIQ-FLUTSsex
Standard Deviation 3.63
|
|
Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores.
Symptom- EOT (N=297; 291)
|
3.9 ICIQ-FLUTSsex
Standard Deviation 3.46
|
3.8 ICIQ-FLUTSsex
Standard Deviation 3.55
|
|
Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores.
Symptom- Change at EOT (N=288; 288)
|
-0.9 ICIQ-FLUTSsex
Standard Deviation 3.53
|
-1.3 ICIQ-FLUTSsex
Standard Deviation 3.75
|
|
Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores.
Bother- Baseline (N=281; 282)
|
9.0 ICIQ-FLUTSsex
Standard Deviation 10.77
|
10.0 ICIQ-FLUTSsex
Standard Deviation 11.47
|
|
Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores.
Bother- EOT (N=263; 262)
|
6.1 ICIQ-FLUTSsex
Standard Deviation 8.52
|
6.6 ICIQ-FLUTSsex
Standard Deviation 9.43
|
|
Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores.
Bother- Change at EOT (N=245; 249)
|
-3.1 ICIQ-FLUTSsex
Standard Deviation 8.11
|
-3.6 ICIQ-FLUTSsex
Standard Deviation 9.04
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each row are noted in the category titles.
The TS-VAS is a instrument utilized to further evaluate the effect of solifenacin succinate on patients' overall satisfaction \& quality of life. Each patient completed a TS-VAS to rate satisfaction with treatment. They were to answer the following question: "Are you satisfied with your treatment?" by placing a mark on a line that ran from 0 (no, not at all) to 100 (yes, completely). Change from baseline with a positive score indicates an improvement. The End of Treatment (EOT) results include patients who had early discontinuation from the study. Change is calculated as EOT - Baseline
Outcome measures
| Measure |
Placebo
n=374 Participants
Matching placebo tablet taken once daily
|
Solifenacin Succinate
n=377 Participants
5mg or 10mg tablet taken once daily
|
|---|---|---|
|
Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS)
Baseline (N=363; 367)
|
32.7 TS-VAS
Standard Deviation 35.29
|
29.0 TS-VAS
Standard Deviation 33.99
|
|
Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS)
End of Treatment (N=363; 367)
|
51.2 TS-VAS
Standard Deviation 38.10
|
67.4 TS-VAS
Standard Deviation 34.38
|
|
Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS)
Change at EOT (N=352; 357)
|
18.4 TS-VAS
Standard Deviation 47.28
|
38.2 TS-VAS
Standard Deviation 45.38
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study drug \& had an OAB-q assessment at both baseline \& at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The number of participants for each timepoint / parameter are noted in the category titles.
The mean parameters recorded for previous 24 hours in the 3-day diary were: number of micturitions, number of incontinence episodes, number of urgency episodes, number of nocturia episodes and number of nocturnal voids. Change from baseline with a lower score indicates an improvement. End of Treatment (EOT) results include patients who had early discontinuation from the study; only patients who had the symptom at baseline and data at the EOT in the 3-day diary are included in the data table. Change is calculated as EOT - Baseline
Outcome measures
| Measure |
Placebo
n=374 Participants
Matching placebo tablet taken once daily
|
Solifenacin Succinate
n=377 Participants
5mg or 10mg tablet taken once daily
|
|---|---|---|
|
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
Urgency Episodes- Change at EOT (N=364;369)
|
-1.84 Number of Category Events / 24 Hours
Standard Deviation 3.891
|
-3.05 Number of Category Events / 24 Hours
Standard Deviation 3.932
|
|
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
Micturitions- Baseline (N=363;369)
|
11.85 Number of Category Events / 24 Hours
Standard Deviation 4.039
|
11.73 Number of Category Events / 24 Hours
Standard Deviation 3.693
|
|
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
Micturitions- End of Treatment (N=363;369)
|
10.49 Number of Category Events / 24 Hours
Standard Deviation 3.645
|
9.50 Number of Category Events / 24 Hours
Standard Deviation 3.869
|
|
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
Micturitions- Change at EOT (N=363;369)
|
-1.36 Number of Category Events / 24 Hours
Standard Deviation 3.203
|
-2.23 Number of Category Events / 24 Hours
Standard Deviation 3.482
|
|
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
Incontinence Episodes- Baseline (N=267;268)
|
2.80 Number of Category Events / 24 Hours
Standard Deviation 2.584
|
2.92 Number of Category Events / 24 Hours
Standard Deviation 2.743
|
|
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
Incontinence Episodes-End of Treatment (N=267;268)
|
1.56 Number of Category Events / 24 Hours
Standard Deviation 2.338
|
1.07 Number of Category Events / 24 Hours
Standard Deviation 2.156
|
|
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
Incontinence Episodes-Change at EOT (N=267;268)
|
-1.24 Number of Category Events / 24 Hours
Standard Deviation 2.545
|
-1.85 Number of Category Events / 24 Hours
Standard Deviation 2.484
|
|
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
Urgency Episodes- Baseline (N=364;369)
|
5.70 Number of Category Events / 24 Hours
Standard Deviation 3.895
|
5.72 Number of Category Events / 24 Hours
Standard Deviation 3.734
|
|
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
Urgency Episodes- End of Treatment (N=364;369)
|
3.86 Number of Category Events / 24 Hours
Standard Deviation 3.795
|
2.66 Number of Category Events / 24 Hours
Standard Deviation 3.381
|
|
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
Nocturia Episodes- Baseline (N=309;313)
|
1.57 Number of Category Events / 24 Hours
Standard Deviation 0.968
|
1.74 Number of Category Events / 24 Hours
Standard Deviation 1.191
|
|
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
Nocturia Episodes- End of Treatment (N=309;313)
|
1.09 Number of Category Events / 24 Hours
Standard Deviation 1.025
|
1.11 Number of Category Events / 24 Hours
Standard Deviation 1.241
|
|
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
Nocturia Episodes- Change at EOT (N=309;313)
|
-0.48 Number of Category Events / 24 Hours
Standard Deviation 1.015
|
-0.63 Number of Category Events / 24 Hours
Standard Deviation 1.132
|
|
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
Nocturnal Voids- Baseline (N=329;326)
|
1.89 Number of Category Events / 24 Hours
Standard Deviation 1.429
|
1.99 Number of Category Events / 24 Hours
Standard Deviation 1.520
|
|
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
Nocturnal Voids- End of Treatment (N=329;326)
|
1.41 Number of Category Events / 24 Hours
Standard Deviation 1.299
|
1.29 Number of Category Events / 24 Hours
Standard Deviation 1.352
|
|
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
Nocturnal Voids- Change at EOT (N=329;326)
|
-0.48 Number of Category Events / 24 Hours
Standard Deviation 1.542
|
-0.70 Number of Category Events / 24 Hours
Standard Deviation 1.513
|
Adverse Events
Placebo
Solifenacin Succinate
Serious adverse events
| Measure |
Placebo
n=382 participants at risk
Matching placebo tablet taken once daily
|
Solifenacin Succinate
n=386 participants at risk
5mg or 10mg tablet taken once daily
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.26%
1/382
|
0.00%
0/386
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/382
|
0.26%
1/386
|
|
Gastrointestinal disorders
Abdominal Strangulated Hernia
|
0.00%
0/382
|
0.26%
1/386
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.26%
1/382
|
0.00%
0/386
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/382
|
0.26%
1/386
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/382
|
0.26%
1/386
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/382
|
0.26%
1/386
|
|
General disorders
Death
|
0.00%
0/382
|
0.26%
1/386
|
|
General disorders
Migration of Implant
|
0.26%
1/382
|
0.00%
0/386
|
|
Infections and infestations
Infection
|
0.00%
0/382
|
0.26%
1/386
|
|
Investigations
Ammonia Increased
|
0.26%
1/382
|
0.00%
0/386
|
|
Investigations
Hypokalaemia
|
0.26%
1/382
|
0.00%
0/386
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.26%
1/382
|
0.00%
0/386
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/382
|
0.26%
1/386
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Discitis
|
0.26%
1/382
|
0.00%
0/386
|
|
Nervous system disorders
Ruptured Cerebral Aneurysm
|
0.26%
1/382
|
0.00%
0/386
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.26%
1/382
|
0.00%
0/386
|
|
Vascular disorders
Thrombosis
|
0.26%
1/382
|
0.00%
0/386
|
Other adverse events
| Measure |
Placebo
n=382 participants at risk
Matching placebo tablet taken once daily
|
Solifenacin Succinate
n=386 participants at risk
5mg or 10mg tablet taken once daily
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.4%
9/382
|
8.3%
32/386
|
|
Gastrointestinal disorders
Dry Mouth
|
2.4%
9/382
|
13.5%
52/386
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER