Trial Outcomes & Findings for Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder. (NCT NCT01093534)
NCT ID: NCT01093534
Last Updated: 2024-12-03
Results Overview
Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.
COMPLETED
PHASE4
547 participants
Baseline and Week 12
2024-12-03
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
186
|
183
|
178
|
|
Overall Study
Received Study Treatment
|
186
|
182
|
175
|
|
Overall Study
COMPLETED
|
176
|
167
|
169
|
|
Overall Study
NOT COMPLETED
|
10
|
16
|
9
|
Reasons for withdrawal
| Measure |
Placebo
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
5
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
2
|
|
Overall Study
Other
|
1
|
3
|
4
|
Baseline Characteristics
Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder.
Baseline characteristics by cohort
| Measure |
Placebo
n=186 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=182 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=175 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Total
n=543 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
186 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
543 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
177 participants
n=5 Participants
|
177 participants
n=7 Participants
|
165 participants
n=5 Participants
|
519 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
13 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set Bladder Wall Thickness (FAS\_BWT): all randomized participants who received at least 1 dose of randomized study medication and who had a mean BWT measurement at Baseline. Analysis includes participants with available data; Last observation carried forward (LOCF) of post-baseline data was used for imputation of missing values.
Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.
Outcome measures
| Measure |
Placebo
n=168 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=160 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=150 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=310 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Bladder Wall Thickness
|
0.00 mm
Standard Deviation 1.26
|
-0.29 mm
Standard Deviation 1.37
|
-0.18 mm
Standard Deviation 1.18
|
-0.24 mm
Standard Deviation 1.28
|
PRIMARY outcome
Timeframe: Week 12Population: Full Analysis Set urinary Nerve Growth Factor subset (FAS\_uNGF0): all randomized participants who received at least 1 dose of randomized study medication and who had an uNGF/Cr measurement at Baseline and on at least 1 visit thereafter, excluding participants with Baseline uNGF below or equal to the laboratory quantification limit. LOCF was used.
Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations \[pg/mL\] by the urine creatinine concentrations (µmol/mL) from the same participant.
Outcome measures
| Measure |
Placebo
n=176 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=175 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=169 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=344 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12
|
30.359 pg/µmol
Standard Deviation 26.1760
|
31.855 pg/µmol
Standard Deviation 29.4371
|
38.917 pg/µmol
Standard Deviation 60.3231
|
35.325 pg/µmol
Standard Deviation 47.2694
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set urinary Nerve Growth Factor subset (FAS\_uNGF0) participants with available data; LOCF was used.
Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations \[pg/mL\] by the urine creatinine concentrations (µmol/mL) from the same participant.
Outcome measures
| Measure |
Placebo
n=176 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=173 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=169 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=342 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Total Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12
|
26.564 pg/µmol
Standard Deviation 23.0347
|
30.135 pg/µmol
Standard Deviation 47.4089
|
34.199 pg/µmol
Standard Deviation 56.2180
|
32.143 pg/µmol
Standard Deviation 51.9123
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set urinary Brain Derived Neurotrophic Factor (FAS\_uBDNF): all randomized participants who received at least 1 dose of randomized study medication, who had given consent for additional analysis and who had an uBDNF/Cr measurement at baseline and on at least 1 visit thereafter. LOCF was used.
Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations \[pg/mL\] by the urine creatinine concentrations (µmol/mL) from the same participant.
Outcome measures
| Measure |
Placebo
n=170 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=170 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=166 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=336 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr) at Week 12
|
116.9 pg/µmol
Standard Deviation 260.5
|
158.1 pg/µmol
Standard Deviation 483.0
|
160.4 pg/µmol
Standard Deviation 373.0
|
159.2 pg/µmol
Standard Deviation 431.6
|
SECONDARY outcome
Timeframe: Baseline, Week 6 and Week 12Population: Full Analysis Set Bladder Wall Thickness (FAS\_BWT) participants with available data at each time point (indicated by n).
Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.
Outcome measures
| Measure |
Placebo
n=175 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=171 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=155 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=326 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 6 and Week 12 in Bladder Wall Thickness
Week 6 (n=157, 145, 141, 286)
|
-0.01 mm
Standard Deviation 1.16
|
-0.04 mm
Standard Deviation 1.27
|
-0.14 mm
Standard Deviation 1.15
|
-0.09 mm
Standard Deviation 1.21
|
|
Change From Baseline to Week 6 and Week 12 in Bladder Wall Thickness
Week 12 (n=160, 143, 135, 278)
|
0.02 mm
Standard Deviation 1.28
|
-0.26 mm
Standard Deviation 1.37
|
-0.22 mm
Standard Deviation 1.18
|
-0.24 mm
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: Baseline, Week 6 and Week 12Population: Full Analysis Set urinary Nerve Growth Factor subset (FAS\_uNGF0) participants with available data at each time point (indicated by n).
Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations \[pg/mL\] by the urine creatinine concentrations (µmol/mL) from the same participant.
Outcome measures
| Measure |
Placebo
n=176 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=175 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=169 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=344 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 6 and Week 12 in Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine
Week 12 (n=173, 171, 166, 337)
|
-1.318 pg/µmol
Standard Deviation 27.9927
|
0.801 pg/µmol
Standard Deviation 33.3120
|
2.625 pg/µmol
Standard Deviation 44.0319
|
1.699 pg/µmol
Standard Deviation 38.9150
|
|
Change From Baseline to Week 6 and Week 12 in Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine
Week 6 (n=168, 163, 160, 323)
|
-4.638 pg/µmol
Standard Deviation 30.7301
|
4.650 pg/µmol
Standard Deviation 38.3159
|
4.309 pg/µmol
Standard Deviation 89.1963
|
4.481 pg/µmol
Standard Deviation 68.3171
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set Bladder Wall Thickness (FAS\_BWT) participants with available data; LOCF was used.
The average number of micturitions (urinations) and incontinence episodes (any involuntary leakage of urine) per day was derived from the number of events recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.
Outcome measures
| Measure |
Placebo
n=144 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=137 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=122 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=259 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Mean Number of Events (Micturitions Plus Incontinence Episodes) Per 24 Hours
|
-1.40 events
Standard Deviation 3.00
|
-2.44 events
Standard Deviation 3.55
|
-1.80 events
Standard Deviation 2.63
|
-2.13 events
Standard Deviation 3.16
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set participants with events at Baseline and with available data; LOCF was used.
The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. An urgency event is defined as any micturition or incontinence episode classified by the participant as a grade 3 or 4 on the PPIUS scale. The average number of urgency events per day is derived from the diary data completed by participants on the 3 days prior to the Baseline and Week 12 visits.
Outcome measures
| Measure |
Placebo
n=139 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=133 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=124 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=257 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Mean Number of Urgency Events Per 24 Hours
|
-1.58 urgency events
Standard Deviation 3.04
|
-2.22 urgency events
Standard Deviation 3.09
|
-1.88 urgency events
Standard Deviation 2.71
|
-2.06 urgency events
Standard Deviation 2.91
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set Bladder Wall Thickness (FAS\_BWT) participants with available data; LOCF was used.
The average number of micturitions (urinations) per 24 hours was derived from the number of micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.
Outcome measures
| Measure |
Placebo
n=144 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=137 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=122 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=259 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Mean Number of Micturitions Per 24 Hours
|
-1.18 micturitions
Standard Deviation 3.03
|
-1.80 micturitions
Standard Deviation 3.77
|
-1.28 micturitions
Standard Deviation 2.61
|
-1.55 micturitions
Standard Deviation 3.28
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set participants with urgency micturitions at Baseline and with available data; LOCF was used.
An urgency micturition is defined as any micturition classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The average number of urgency micturitions per 24 hours was derived from the number of urgency micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.
Outcome measures
| Measure |
Placebo
n=137 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=130 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=117 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=247 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Mean Number of Urgency Micturitions Per 24 Hours
|
-1.35 urgency micturitions
Standard Deviation 2.86
|
-1.77 urgency micturitions
Standard Deviation 2.99
|
-1.60 urgency micturitions
Standard Deviation 2.45
|
-1.69 urgency micturitions
Standard Deviation 2.75
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with incontinence events at Baseline and with available data; LOCF was used.
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was calculated from the number of incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.
Outcome measures
| Measure |
Placebo
n=67 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=62 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=74 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=136 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
|
-0.60 incontinence episodes
Standard Deviation 1.65
|
-1.49 incontinence episodes
Standard Deviation 1.65
|
-1.04 incontinence episodes
Standard Deviation 1.76
|
-1.24 incontinence episodes
Standard Deviation 1.72
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with grade 3 or 4 urgency incontinence events at Baseline and with available data; LOCF was used.
An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The average number of grade 3 or 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=56 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=69 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=125 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 3 or 4 Per 24 Hours
|
-0.71 urgency incontinence episodes
Standard Deviation 1.52
|
-1.32 urgency incontinence episodes
Standard Deviation 1.63
|
-0.90 urgency incontinence episodes
Standard Deviation 1.23
|
-1.09 urgency incontinence episodes
Standard Deviation 1.43
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set participants with grade 4 urgency incontinence events at Baseline and with available data; LOCF was used.
An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The average number of grade 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=49 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=61 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=110 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 4 Per 24 Hours
|
-0.70 urgency incontinence episodes
Standard Deviation 1.46
|
-0.96 urgency incontinence episodes
Standard Deviation 0.91
|
-0.70 urgency incontinence episodes
Standard Deviation 1.16
|
-0.82 urgency incontinence episodes
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set Bladder Wall Thickness (FAS\_BWT) participants with available data; LOCF was used.
The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean level of urgency was calculated by adding the PPIUS grade for all events (micturition or incontinence) and dividing by the number of episodes recorded in the diary over 3 days prior to the Baseline and Week 12 visits.
Outcome measures
| Measure |
Placebo
n=144 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=137 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=122 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=259 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Mean Level of Urgency
|
-0.15 units on a scale
Standard Deviation 0.525
|
-0.23 units on a scale
Standard Deviation 0.504
|
-0.24 units on a scale
Standard Deviation 0.578
|
-0.23 units on a scale
Standard Deviation 0.539
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set Bladder Wall Thickness (FAS\_BWT) participants with available data; LOCF was used.
The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The total urgency score was calculated by adding all PPIUS scores over a 3-day period prior to the Baseline and Week 12 visits for each participant.
Outcome measures
| Measure |
Placebo
n=144 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=137 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=122 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=259 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Total Urgency Score
|
-13.61 units on a scale
Standard Deviation 25.98
|
-22.39 units on a scale
Standard Deviation 29.80
|
-16.91 units on a scale
Standard Deviation 22.57
|
-19.81 units on a scale
Standard Deviation 26.73
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set Bladder Wall Thickness (FAS\_BWT) participants with available data; LOCF was used.
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.
Outcome measures
| Measure |
Placebo
n=175 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=171 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=153 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=324 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Patient Perception of Bladder Condition (PPBC)
|
-0.7 units on a scale
Standard Deviation 1.33
|
-1.3 units on a scale
Standard Deviation 1.38
|
-1.3 units on a scale
Standard Deviation 1.26
|
-1.3 units on a scale
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set Bladder Wall Thickness (FAS\_BWT) participants with available data; LOCF was used.
The participants' perception and impression of bother associated with their condition were assessed using the Urgency Bother-Visual Analog Scale (UB-VAS). The participant was asked to place a vertical mark on a 100 mm line to indicate how much bother has urgency been for them in the past week, whereby 'no bother at all' is represented on the left end (score = 0) and 'worst possible bother' (score = 100) at the right end of the line. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=175 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=171 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=153 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=324 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Patient Assessment of Urgency Bother
|
-12.60 units on a scale
Standard Deviation 29.51
|
-27.70 units on a scale
Standard Deviation 30.39
|
-28.90 units on a scale
Standard Deviation 28.72
|
-28.20 units on a scale
Standard Deviation 29.57
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set Bladder Wall Thickness (FAS\_BWT) participants with available data; LOCF was used.
The treatment satisfaction visual analog scale (TS\_VAS) asks patients to rate their satisfaction with treatment by placing a vertical mark on a 100 mm line where the endpoints are labeled 'No, not at all' on the left (score = 0) to 'Yes, completely satisfied' on the right (score = 100). A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=175 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=171 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=153 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=324 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Patient Assessment of Treatment Satisfaction
|
18.90 units on a scale
Standard Deviation 42.18
|
24.90 units on a scale
Standard Deviation 39.58
|
31.90 units on a scale
Standard Deviation 41.02
|
28.20 units on a scale
Standard Deviation 40.36
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set Bladder Wall Thickness (FAS\_BWT) participants with available data.
The participants' quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D). The EQ-5D is a standardized instrument for use as a measure of health outcome and is based on the following 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension participants were asked to select the statement which best described their health that day, from level 1 (indicating no problems) to 3 (indicating extreme problems/unable to perform). Improvement was defined as a change from a state of being unable to perform or extreme problems at Baseline to no problems or to some or moderate problems at Week 12, and from some or moderate problems to no problems. Worsening was defined as a change from no problems at Baseline to some or moderate problems or to a state of being unable to perform or extreme problems at Week 12, and from some or moderate problems to a state of being unable to perform or extreme problems.
Outcome measures
| Measure |
Placebo
n=165 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=155 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=146 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=301 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D
Pain/Discomfort: Worsening
|
10.3 percentage of participants
|
11.0 percentage of participants
|
4.8 percentage of participants
|
8.0 percentage of participants
|
|
Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D
Mobility: Improvement
|
6.7 percentage of participants
|
10.3 percentage of participants
|
9.6 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D
Mobility: Worsening
|
10.3 percentage of participants
|
7.1 percentage of participants
|
3.4 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D
Self-care: Improvement
|
2.4 percentage of participants
|
3.9 percentage of participants
|
3.4 percentage of participants
|
3.7 percentage of participants
|
|
Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D
Self-care: Worsening
|
2.4 percentage of participants
|
3.2 percentage of participants
|
4.1 percentage of participants
|
3.7 percentage of participants
|
|
Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D
Usual Activities: Improvement
|
7.9 percentage of participants
|
7.7 percentage of participants
|
11.0 percentage of participants
|
9.3 percentage of participants
|
|
Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D
Usual Activities: Worsening
|
7.9 percentage of participants
|
11.0 percentage of participants
|
4.8 percentage of participants
|
8.0 percentage of participants
|
|
Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D
Pain/Discomfort: Improvement
|
15.2 percentage of participants
|
19.4 percentage of participants
|
18.5 percentage of participants
|
18.9 percentage of participants
|
|
Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D
Anxiety/Depression: Improvement
|
17.0 percentage of participants
|
17.4 percentage of participants
|
19.9 percentage of participants
|
18.6 percentage of participants
|
|
Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D
Anxiety/Depression: Worsening
|
10.3 percentage of participants
|
11.0 percentage of participants
|
13.7 percentage of participants
|
12.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set Bladder Wall Thickness (FAS\_BWT) participants with available data; LOCF was used.
The participants' quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D) visual analog scale (VAS). Health status is completed by the participant indicating their own health state today by drawing a line on a vertical scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=175 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=171 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=153 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=324 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in EuroQoL 5-Dimension Questionnaire Visual Analog Scale
|
3.60 units on a scale
Standard Deviation 16.86
|
4.80 units on a scale
Standard Deviation 20.22
|
5.10 units on a scale
Standard Deviation 17.86
|
4.90 units on a scale
Standard Deviation 19.12
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set Bladder Wall Thickness (FAS\_BWT) participants with available data; LOCF was used.
Overactive bladder symptoms were assessed using the symptom bother scale of the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising an 8-item symptom bother scale and 25 health-related quality of life items (see next outcome measure). In the symptom bother scale participants were asked how much they had been bothered by selected bladder symptoms during the past 4 weeks. Each question has a 6-point Likert scale response ranging from 'not at all' (1) to 'a very great deal' (6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvement.
Outcome measures
| Measure |
Placebo
n=175 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=171 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=153 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=324 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Symptom Bother Score
|
-14.90 units on a scale
Standard Deviation 19.11
|
-22.32 units on a scale
Standard Deviation 20.59
|
-22.91 units on a scale
Standard Deviation 18.69
|
-22.60 units on a scale
Standard Deviation 19.69
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set Bladder Wall Thickness (FAS\_BWT) participants with available data; LOCF was used.
Health-related quality of life was assessed by the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising of an 8-item symptom bother scale (see previous outcome measure) and 25 HRQL items comprising 4 subscales (concern, coping, social interaction and sleep) and a total HRQL score. Participants were asked how their overall bladder symptoms had affected their life in the past 4 weeks. Each of the 25 HRQL questions has a 6-point Likert scale response ranging from 'none of the time' (1) to 'all of the time' (6). The HRQL subscale scores were calculated by summing the responses of the items within each subscale.The HRQL total score was calculated by adding the 4 HRQL subscale scores,. All scores were transformed to a scale from 0 to 100 where higher scores indicate better quality of life. A positive change from Baseline in HRQL score indicates improvement.
Outcome measures
| Measure |
Placebo
n=175 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=171 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=153 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=324 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Health-Related Quality of Life (HRQL)
Total score
|
11.72 units on a scale
Standard Deviation 16.71
|
17.25 units on a scale
Standard Deviation 19.74
|
17.69 units on a scale
Standard Deviation 15.75
|
17.46 units on a scale
Standard Deviation 17.94
|
|
Change From Baseline in Health-Related Quality of Life (HRQL)
Coping subscale
|
12.40 units on a scale
Standard Deviation 18.85
|
18.26 units on a scale
Standard Deviation 20.89
|
20.21 units on a scale
Standard Deviation 19.42
|
19.18 units on a scale
Standard Deviation 20.20
|
|
Change From Baseline in Health-Related Quality of Life (HRQL)
Concern subscale
|
13.80 units on a scale
Standard Deviation 18.64
|
20.35 units on a scale
Standard Deviation 22.52
|
20.77 units on a scale
Standard Deviation 18.73
|
20.55 units on a scale
Standard Deviation 20.79
|
|
Change From Baseline in Health-Related Quality of Life (HRQL)
Sleep subscale
|
10.80 units on a scale
Standard Deviation 19.31
|
15.50 units on a scale
Standard Deviation 21.33
|
15.10 units on a scale
Standard Deviation 15.95
|
15.30 units on a scale
Standard Deviation 18.95
|
|
Change From Baseline in Health-Related Quality of Life (HRQL)
Social interaction subscale
|
8.70 units on a scale
Standard Deviation 16.95
|
13.00 units on a scale
Standard Deviation 19.65
|
12.00 units on a scale
Standard Deviation 15.54
|
12.50 units on a scale
Standard Deviation 17.81
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set urinary Brain Derived Neurotrophic Factor (FAS\_uBDNF); LOCF was used.
Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations \[pg/mL\] by the urine creatinine concentrations (µmol/mL) from the same participant.
Outcome measures
| Measure |
Placebo
n=170 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=170 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=166 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=336 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr)
|
-27.4 pg/µmol
Standard Deviation 317.6
|
31.1 pg/µmol
Standard Deviation 426.9
|
-88.1 pg/µmol
Standard Deviation 980.6
|
-27.8 pg/µmol
Standard Deviation 754.4
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set urinary Nerve Growth Factor subset (FAS\_uNGF0) participants with available data; LOCF was used.
Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations \[pg/mL\] by the urine creatinine concentrations (µmol/mL) from the same participant.
Outcome measures
| Measure |
Placebo
n=176 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=173 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=169 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=342 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Total Urinary Nerve Growth Factor Normalized by Urine Creatinine
|
-0.962 pg/µmol
Standard Deviation 24.2241
|
2.758 pg/µmol
Standard Deviation 49.0191
|
3.858 pg/µmol
Standard Deviation 44.0421
|
3.302 pg/µmol
Standard Deviation 46.5612
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set Bladder Wall Thickness (FAS\_BWT) participants with available data; LOCF was used.
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement: ≥ 1 point improvement compared to Baseline; Major Improvement: ≥ 2 point improvement compared to Baseline; Deterioration: ≥ 1 point deterioration compared to Baseline.
Outcome measures
| Measure |
Placebo
n=175 Participants
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=171 Participants
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=153 Participants
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
Pooled Solifenacin
n=324 Participants
Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Improvement or Deterioration in Patient Perception of Bladder Condition (PPBC)
Deterioration
|
15.4 percentage of participants
|
6.4 percentage of participants
|
5.2 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants With Improvement or Deterioration in Patient Perception of Bladder Condition (PPBC)
No change
|
34.9 percentage of participants
|
21.6 percentage of participants
|
20.3 percentage of participants
|
21.0 percentage of participants
|
|
Percentage of Participants With Improvement or Deterioration in Patient Perception of Bladder Condition (PPBC)
Improvement
|
49.7 percentage of participants
|
71.9 percentage of participants
|
74.5 percentage of participants
|
73.1 percentage of participants
|
|
Percentage of Participants With Improvement or Deterioration in Patient Perception of Bladder Condition (PPBC)
Major Improvement
|
27.4 percentage of participants
|
39.8 percentage of participants
|
44.4 percentage of participants
|
42.0 percentage of participants
|
Adverse Events
Placebo
Solifenacin 5 mg
Solifenacin 10 mg
Serious adverse events
| Measure |
Placebo
n=186 participants at risk
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=182 participants at risk
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=175 participants at risk
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/186 • 12 weeks
|
0.00%
0/182 • 12 weeks
|
0.57%
1/175 • 12 weeks
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.00%
0/186 • 12 weeks
|
0.55%
1/182 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/186 • 12 weeks
|
0.55%
1/182 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Infections and infestations
Endotoxic shock
|
0.00%
0/186 • 12 weeks
|
0.55%
1/182 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/186 • 12 weeks
|
0.00%
0/182 • 12 weeks
|
0.57%
1/175 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/186 • 12 weeks
|
0.55%
1/182 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.54%
1/186 • 12 weeks
|
0.00%
0/182 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/186 • 12 weeks
|
0.55%
1/182 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/186 • 12 weeks
|
0.55%
1/182 • 12 weeks
|
0.00%
0/175 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.00%
0/186 • 12 weeks
|
0.00%
0/182 • 12 weeks
|
0.57%
1/175 • 12 weeks
|
|
Nervous system disorders
Sciatica
|
0.00%
0/186 • 12 weeks
|
0.00%
0/182 • 12 weeks
|
0.57%
1/175 • 12 weeks
|
Other adverse events
| Measure |
Placebo
n=186 participants at risk
Participants received 2 placebo tablets once daily for 12 weeks.
|
Solifenacin 5 mg
n=182 participants at risk
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
|
Solifenacin 10 mg
n=175 participants at risk
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
1.1%
2/186 • 12 weeks
|
8.8%
16/182 • 12 weeks
|
17.1%
30/175 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
3.8%
7/186 • 12 weeks
|
4.4%
8/182 • 12 weeks
|
5.1%
9/175 • 12 weeks
|
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 60 days prior to publication for review and comment. Sponsor may delay the publication for up to 6 months to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER