Trial Outcomes & Findings for Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction (NCT NCT00507455)
NCT ID: NCT00507455
Last Updated: 2014-08-06
Results Overview
Detrusor pressure (Pdet) measures the force the detrusor muscle is exerting. This pressure is required to expel urine from the bladder during normal voiding. A high detrusor pressure may be observed in the presence of outflow tract obstruction. Detrusor pressure at maximum urinary flow rate (PdetQmax) was evaluated using simultaneous recording of urinary voiding by an uroflowmeter during detrusor pressure evaluation by cystometry.
COMPLETED
PHASE2
222 participants
Baseline and Week 12
2014-08-06
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
Participants received once daily oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin hydrochloride Oral Control Absorption System (TOCAS)tablets for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
74
|
74
|
74
|
|
Overall Study
COMPLETED
|
62
|
68
|
62
|
|
Overall Study
NOT COMPLETED
|
12
|
6
|
12
|
Reasons for withdrawal
| Measure |
Placebo
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
Participants received once daily oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin hydrochloride Oral Control Absorption System (TOCAS)tablets for 12 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
6
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
2
|
|
Overall Study
Protocol Violation
|
4
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
|
Overall Study
Other - miscellaneous reason
|
1
|
0
|
1
|
Baseline Characteristics
Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction
Baseline characteristics by cohort
| Measure |
Placebo
n=74 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=74 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=74 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 7.60 • n=99 Participants
|
63.8 years
STANDARD_DEVIATION 8.43 • n=107 Participants
|
65.6 years
STANDARD_DEVIATION 8.26 • n=206 Participants
|
64.6 years
STANDARD_DEVIATION 8.11 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
222 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
71 participants
n=99 Participants
|
74 participants
n=107 Participants
|
69 participants
n=206 Participants
|
214 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic or Latino
|
72 participants
n=99 Participants
|
71 participants
n=107 Participants
|
69 participants
n=206 Participants
|
212 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
10 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set (FAS) population consisted of participants who received at least one dose of double-blind treatment and had both urodynamic measurements at baseline and one or both measured at any post-baseline on-treatment visit. Last observation carried forward (LOCF) imputation was used.
Detrusor pressure (Pdet) measures the force the detrusor muscle is exerting. This pressure is required to expel urine from the bladder during normal voiding. A high detrusor pressure may be observed in the presence of outflow tract obstruction. Detrusor pressure at maximum urinary flow rate (PdetQmax) was evaluated using simultaneous recording of urinary voiding by an uroflowmeter during detrusor pressure evaluation by cystometry.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=67 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=58 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)
|
-1.69 cmH2O
Standard Error 3.15
|
-7.84 cmH2O
Standard Error 2.95
|
-6.69 cmH2O
Standard Error 3.20
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set (FAS) population consisted of participants who received at least one dose of double-blind treatment and had urodynamic measurements at baseline and post-baseline on-treatment visit. Last observation carried forward (LOCF) imputation was used.
The maximum flow rate (Qmax) during a micturition (urination) was recorded using uroflowmetry. A reduction in maximum flow rate may be due to an obstruction of the bladder outlet or a failure of the detrusor muscle to aid in expelling urine.
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=67 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=59 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
|
0.17 mL/sec
Standard Error 0.43
|
1.85 mL/sec
Standard Error 0.41
|
2.35 mL/sec
Standard Error 0.43
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full analysis set (FAS) population with available data at each time point (as indicated by "N"). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.
Healthy micturitions result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding (post-void residual urine). Post void residual volume was assessed by abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation. End-of-treatment is the last post-baseline assessment during the treatment period. Least squares (LS) means were adjusted for pooled center and the Baseline value.
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=67 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=59 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Post Void Residual Volume (PVR)
Week 2 (N=61, 67, 58)
|
-10.21 mL
Standard Error 6.912
|
16.78 mL
Standard Error 6.525
|
8.97 mL
Standard Error 7.015
|
|
Change From Baseline in Post Void Residual Volume (PVR)
Week 4 (N=60, 67, 59)
|
-7.86 mL
Standard Error 6.225
|
14.92 mL
Standard Error 5.830
|
9.65 mL
Standard Error 6.229
|
|
Change From Baseline in Post Void Residual Volume (PVR)
Week 8 (N=58, 66, 58)
|
-12.44 mL
Standard Error 6.434
|
9.64 mL
Standard Error 5.950
|
6.64 mL
Standard Error 6.373
|
|
Change From Baseline in Post Void Residual Volume (PVR)
Week 12 (N=57, 63, 57)
|
1.16 mL
Standard Error 7.346
|
26.81 mL
Standard Error 6.843
|
18.72 mL
Standard Error 7.244
|
|
Change From Baseline in Post Void Residual Volume (PVR)
End of Treatment (N=62, 67, 59)
|
0.14 mL
Standard Error 6.809
|
25.63 mL
Standard Error 6.477
|
19.07 mL
Standard Error 6.923
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set (FAS) population; Last observation carried forward (LOCF) imputation was used.
The Bladder Contractility Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula: BCI = pdetQmax + 5Qmax. Strong contractility is a BCI \> 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of \< 100. LS means were adjusted for pooled center and Baseline value.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=67 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=58 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline to End of Treatment in Bladder Contractility Index (BCI)
|
-1.63 units on a scale
Standard Error 3.705
|
1.84 units on a scale
Standard Error 3.475
|
3.86 units on a scale
Standard Error 3.764
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set (FAS) population; Last observation carried forward (LOCF) imputation was used.
Percent Bladder Voiding Efficiency (BVE) is a product of bladder contractility against the urethral resistance and is measured according to the degree of bladder emptying. BVE is expressed as a percentage and is calculated using the formula: Bladder Voiding efficiency = (Voided volume x 100)/maximum cystometric capacity. A higher number indicates a higher voiding efficiency. LS means were adjusted for pooled center and Baseline value.
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=67 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=59 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE)
|
-0.67 Percent voiding efficiency
Standard Error 2.757
|
-1.38 Percent voiding efficiency
Standard Error 2.634
|
-3.79 Percent voiding efficiency
Standard Error 2.812
|
SECONDARY outcome
Timeframe: From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).Population: Safety analysis set population consisted of participants who received at least 1 dose of double-blind treatment.
Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=74 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=74 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
Deaths
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
Any adverse event
|
29 participants
|
38 participants
|
37 participants
|
|
Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
Mild adverse event
|
21 participants
|
21 participants
|
20 participants
|
|
Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
Moderate adverse event
|
6 participants
|
13 participants
|
12 participants
|
|
Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
Severe adverse event
|
2 participants
|
4 participants
|
5 participants
|
|
Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
Serious adverse event
|
1 participants
|
2 participants
|
2 participants
|
|
Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
AE leading to study drug discontinuation
|
3 participants
|
3 participants
|
6 participants
|
|
Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
Drug-related adverse events
|
15 participants
|
24 participants
|
26 participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.
The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms and is based on the answers to 7 questions concerning urinary symptoms: * Sensation of incomplete emptying * Repeat urinating after 2 hours (frequency) * Start and stop several times (intermittency) * Urgency * Weak stream * Straining * Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Least squares (LS) means were adjusted for pooled center and the Baseline value.
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=67 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=59 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Prostate Symptoms Score (IPSS)
End of Treatment (N=62, 67, 59)
|
-6.6 units on a scale
Standard Error 0.65
|
-8.0 units on a scale
Standard Error 0.62
|
-6.9 units on a scale
Standard Error 0.66
|
|
Change From Baseline in International Prostate Symptoms Score (IPSS)
Week 2 (N=61, 67, 58)
|
-3.8 units on a scale
Standard Error 0.58
|
-4.5 units on a scale
Standard Error 0.54
|
-4.7 units on a scale
Standard Error 0.59
|
|
Change From Baseline in International Prostate Symptoms Score (IPSS)
Week 4 (N=60, 65, 57)
|
-5.3 units on a scale
Standard Error 0.63
|
-6.4 units on a scale
Standard Error 0.59
|
-6.2 units on a scale
Standard Error 0.64
|
|
Change From Baseline in International Prostate Symptoms Score (IPSS)
Week 8 (N=58, 67, 57)
|
-6.8 units on a scale
Standard Error 0.74
|
-7.1 units on a scale
Standard Error 0.68
|
-6.9 units on a scale
Standard Error 0.74
|
|
Change From Baseline in International Prostate Symptoms Score (IPSS)
Week 12 (N=58, 63, 57)
|
-6.9 units on a scale
Standard Error 0.66
|
-7.9 units on a scale
Standard Error 0.62
|
-7.2 units on a scale
Standard Error 0.66
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.
The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic). Least squares (LS) means were adjusted for pooled center and the Baseline value.
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=67 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=59 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in IPSS Voiding Score
End of Treatment (N=62, 67, 59)
|
-3.9 units on a scale
Standard Error 0.44
|
-4.6 units on a scale
Standard Error 0.42
|
-3.9 units on a scale
Standard Error 0.45
|
|
Change From Baseline in IPSS Voiding Score
Week 12 (N=58, 64, 57)
|
-4.0 units on a scale
Standard Error 0.45
|
-4.7 units on a scale
Standard Error 0.42
|
-4.1 units on a scale
Standard Error 0.45
|
|
Change From Baseline in IPSS Voiding Score
Week 4 (N=60, 65, 57)
|
-3.2 units on a scale
Standard Error 0.45
|
-3.8 units on a scale
Standard Error 0.42
|
-3.6 units on a scale
Standard Error 0.46
|
|
Change From Baseline in IPSS Voiding Score
Week 2 (N=61, 67, 58)
|
-2.2 units on a scale
Standard Error 0.39
|
-2.9 units on a scale
Standard Error 0.37
|
-2.6 units on a scale
Standard Error 0.40
|
|
Change From Baseline in IPSS Voiding Score
Week 8 (N=58, 67, 57)
|
-4.1 units on a scale
Standard Error 0.49
|
-4.3 units on a scale
Standard Error 0.45
|
-3.8 units on a scale
Standard Error 0.49
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.
The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic). Least squares (LS) means were adjusted for pooled center and the Baseline value.
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=67 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=59 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in IPSS Storage Score
Week 2 (N=62, 67, 58)
|
-1.5 units on a scale
Standard Error 0.29
|
-1.6 units on a scale
Standard Error 0.27
|
-2.1 units on a scale
Standard Error 0.29
|
|
Change From Baseline in IPSS Storage Score
Week 4 (N=60, 66, 58)
|
-2.1 units on a scale
Standard Error 0.30
|
-2.6 units on a scale
Standard Error 0.28
|
-2.5 units on a scale
Standard Error 0.30
|
|
Change From Baseline in IPSS Storage Score
Week 8 (N=58, 67, 58)
|
-2.7 units on a scale
Standard Error 0.34
|
-2.8 units on a scale
Standard Error 0.31
|
-3.1 units on a scale
Standard Error 0.33
|
|
Change From Baseline in IPSS Storage Score
Week 12 (N=58, 63, 57)
|
-2.8 units on a scale
Standard Error 0.30
|
-3.3 units on a scale
Standard Error 0.29
|
-3.1 units on a scale
Standard Error 0.30
|
|
Change From Baseline in IPSS Storage Score
End of Treatment (N=62, 67, 59)
|
-2.7 units on a scale
Standard Error 0.30
|
-3.4 units on a scale
Standard Error 0.28
|
-3.0 units on a scale
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.
The patient perception of bladder condition (PPBC) questionnaire asks participants to assess their bladder condition using a 6-point validated Likert scale which ranges from 1 (does not cause me any problems at all) to 6 (causes me many severe problems). Least squares (LS) means were adjusted for pooled center and the Baseline value.
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=67 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=59 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Patient Perception of Bladder Condition (PPBC)
Week 2 (N=61, 66, 58)
|
-0.5 units on a scale
Standard Error 0.12
|
-0.3 units on a scale
Standard Error 0.11
|
-0.5 units on a scale
Standard Error 0.12
|
|
Change From Baseline in Patient Perception of Bladder Condition (PPBC)
Week 4 (N=60, 66, 58)
|
-0.7 units on a scale
Standard Error 0.13
|
-0.5 units on a scale
Standard Error 0.12
|
-0.9 units on a scale
Standard Error 0.13
|
|
Change From Baseline in Patient Perception of Bladder Condition (PPBC)
Week 8 (N=58, 67, 58)
|
-1.0 units on a scale
Standard Error 0.14
|
-0.8 units on a scale
Standard Error 0.13
|
-1.1 units on a scale
Standard Error 0.14
|
|
Change From Baseline in Patient Perception of Bladder Condition (PPBC)
Week 12 (N=58, 64, 57)
|
-1.1 units on a scale
Standard Error 0.14
|
-1.0 units on a scale
Standard Error 0.13
|
-1.1 units on a scale
Standard Error 0.14
|
|
Change From Baseline in Patient Perception of Bladder Condition (PPBC)
End of Treatment (N=62, 67, 59)
|
-1.1 units on a scale
Standard Error 0.13
|
-0.9 units on a scale
Standard Error 0.13
|
-1.1 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.
A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. Least squares (LS) means were adjusted for pooled center and the Baseline value.
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=67 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=59 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Number of Micturitions Per 24 Hours
Week 12 (N=58, 65, 58)
|
-1.07 micturitions
Standard Error 0.333
|
-1.91 micturitions
Standard Error 0.309
|
-1.89 micturitions
Standard Error 0.330
|
|
Change From Baseline in Number of Micturitions Per 24 Hours
Week 2 (N=60, 67, 59)
|
-0.44 micturitions
Standard Error 0.261
|
-1.25 micturitions
Standard Error 0.243
|
-1.19 micturitions
Standard Error 0.261
|
|
Change From Baseline in Number of Micturitions Per 24 Hours
Week 4 (N=60, 65, 58)
|
-1.03 micturitions
Standard Error 0.285
|
-1.32 micturitions
Standard Error 0.270
|
-1.72 micturitions
Standard Error 0.287
|
|
Change From Baseline in Number of Micturitions Per 24 Hours
Week 8 (N=58, 67, 58)
|
-1.33 micturitions
Standard Error 0.330
|
-1.31 micturitions
Standard Error 0.302
|
-2.00 micturitions
Standard Error 0.327
|
|
Change From Baseline in Number of Micturitions Per 24 Hours
End of Treatment (N=60, 67, 59)
|
-0.95 micturitions
Standard Error 0.328
|
-1.91 micturitions
Standard Error 0.306
|
-1.87 micturitions
Standard Error 0.328
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.
For each micturition and/or incontinence episode participants rated the degree of associated urgency (the sudden compelling desire to pass urine, which is difficult to defer) according to the following scale: 0: No Urgency, felt no need to empty my bladder but did so for another reason; 1: Mild urgency, could postpone passing water for as long as necessary; 2: Moderate urgency, could postpone passing water for a short while; 3: Severe urgency, could not postpone passing water; 4: Urge incontinence, leaked before reaching the toilet. An urgency episode is defined as an episode with urgency severity of three or higher. The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. Least squares (LS) means were adjusted for pooled center and the Baseline value.
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=67 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=59 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Number of Urgency Episodes Per 24 Hours
Week 4 (N=60, 65, 58)
|
-1.18 urgency episodes
Standard Error 0.254
|
-1.39 urgency episodes
Standard Error 0.240
|
-1.34 urgency episodes
Standard Error 0.255
|
|
Change From Baseline in Number of Urgency Episodes Per 24 Hours
Week 12 (N=58, 65, 58)
|
-1.47 urgency episodes
Standard Error 0.247
|
-1.54 urgency episodes
Standard Error 0.230
|
-1.18 urgency episodes
Standard Error 0.245
|
|
Change From Baseline in Number of Urgency Episodes Per 24 Hours
End of Treatment (N=60, 67, 59)
|
-1.41 urgency episodes
Standard Error 0.249
|
-1.45 urgency episodes
Standard Error 0.232
|
-1.23 urgency episodes
Standard Error 0.249
|
|
Change From Baseline in Number of Urgency Episodes Per 24 Hours
Week 2 (N=60, 67, 59)
|
-0.59 urgency episodes
Standard Error 0.246
|
-0.89 urgency episodes
Standard Error 0.230
|
-0.95 urgency episodes
Standard Error 0.246
|
|
Change From Baseline in Number of Urgency Episodes Per 24 Hours
Week 8 (N=58, 67, 58)
|
-1.45 urgency episodes
Standard Error 0.263
|
-1.34 urgency episodes
Standard Error 0.241
|
-1.08 urgency episodes
Standard Error 0.261
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full analysis set (FAS) population who had 3-day averaged incontinence episodes \>0 at Baseline and with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.
The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. Least squares (LS) means were adjusted for pooled center and the Baseline value.
Outcome measures
| Measure |
Placebo
n=13 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=10 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=13 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Number of Incontinence Episodes Per 24 Hours
Week 2 (N=13, 10, 13)
|
-0.81 incontinence episodes
Standard Error 0.368
|
-1.45 incontinence episodes
Standard Error 0.412
|
-1.01 incontinence episodes
Standard Error 0.352
|
|
Change From Baseline in Number of Incontinence Episodes Per 24 Hours
Week 4 (N=13, 10, 13)
|
-1.00 incontinence episodes
Standard Error 0.533
|
-1.45 incontinence episodes
Standard Error 0.596
|
-0.81 incontinence episodes
Standard Error 0.508
|
|
Change From Baseline in Number of Incontinence Episodes Per 24 Hours
End of Treatment (N=13, 10, 13)
|
-1.54 incontinence episodes
Standard Error 0.571
|
-1.66 incontinence episodes
Standard Error 0.639
|
-1.02 incontinence episodes
Standard Error 0.545
|
|
Change From Baseline in Number of Incontinence Episodes Per 24 Hours
Week 8 (N=12, 10, 12)
|
-1.86 incontinence episodes
Standard Error 0.489
|
-1.55 incontinence episodes
Standard Error 0.508
|
-0.78 incontinence episodes
Standard Error 0.453
|
|
Change From Baseline in Number of Incontinence Episodes Per 24 Hours
Week 12 (N=12, 9, 12)
|
-1.99 incontinence episodes
Standard Error 0.600
|
-1.48 incontinence episodes
Standard Error 0.654
|
-0.85 incontinence episodes
Standard Error 0.551
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.
The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. Least squares (LS) means were adjusted for pooled center and the Baseline value.
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=67 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=59 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Volume Voided Per Micturition
Week 2 (N=60, 67, 59)
|
9.36 mL
Standard Error 4.415
|
31.46 mL
Standard Error 4.109
|
18.25 mL
Standard Error 4.408
|
|
Change From Baseline in Volume Voided Per Micturition
Week 4 (N=60, 65, 58)
|
10.40 mL
Standard Error 5.207
|
35.27 mL
Standard Error 4.920
|
30.34 mL
Standard Error 5.236
|
|
Change From Baseline in Volume Voided Per Micturition
Week 8 (N=58, 67, 58)
|
10.50 mL
Standard Error 6.125
|
33.72 mL
Standard Error 5.596
|
35.53 mL
Standard Error 6.064
|
|
Change From Baseline in Volume Voided Per Micturition
Week 12 (N=58, 65, 58)
|
9.03 mL
Standard Error 5.703
|
35.02 mL
Standard Error 5.283
|
31.18 mL
Standard Error 5.643
|
|
Change From Baseline in Volume Voided Per Micturition
End of Treatment (N=60, 67, 59)
|
7.56 mL
Standard Error 5.700
|
36.26 mL
Standard Error 5.305
|
30.33 mL
Standard Error 5.691
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8 and 12Population: Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as "N"). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.
Male lower urinary tract symptoms were assessed by the ICIQ MLUTS questionnaire which consists of 13 questions regarding urinary symptoms. Each question is answered by the participant on a scale from 0 (never) to 4 (all the time). The total symptom score ranges from 0 to 52, where larger scores correspond to worse conditions. Least squares (LS) means were adjusted for pooled center and the Baseline value.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=66 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=57 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score
End of Treatment (N=60, 66, 57)
|
-5.2 units on a scale
Standard Error 0.69
|
-6.0 units on a scale
Standard Error 0.65
|
-5.8 units on a scale
Standard Error 0.71
|
|
Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score
Week 4 (N=58, 66, 52)
|
-3.9 units on a scale
Standard Error 0.60
|
-4.5 units on a scale
Standard Error 0.56
|
-4.6 units on a scale
Standard Error 0.64
|
|
Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score
Week 8 (N=55, 63, 53)
|
-5.5 units on a scale
Standard Error 0.68
|
-5.6 units on a scale
Standard Error 0.63
|
-5.8 units on a scale
Standard Error 0.70
|
|
Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score
Week 12 (N=55, 61, 53)
|
-5.5 units on a scale
Standard Error 0.70
|
-6.5 units on a scale
Standard Error 0.66
|
-5.9 units on a scale
Standard Error 0.71
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8 and 12Population: Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as "N"). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.
The degree to which urinary symptoms bothered participants was assessed by the ICIQ MLUTS questionnaire which consists of 13 symptom bother questions. Each question is answered by the participant on a scale from 0 (not at all) to 10 (a great deal). The total bother score ranges from 0 to 130, where larger scores correspond to worse outcomes. Least squares (LS) means were adjusted for pooled center and the Baseline value.
Outcome measures
| Measure |
Placebo
n=58 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=61 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=54 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score
Week 12 (N=51, 51, 47)
|
-22.6 units on a scale
Standard Error 2.78
|
-23.9 units on a scale
Standard Error 2.74
|
-23.9 units on a scale
Standard Error 2.91
|
|
Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score
Week 4 (N=52, 57, 48)
|
-14.6 units on a scale
Standard Error 2.76
|
-11.0 units on a scale
Standard Error 2.62
|
-17.0 units on a scale
Standard Error 2.88
|
|
Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score
Week 8 (N=51, 55, 47)
|
-20.7 units on a scale
Standard Error 2.88
|
-19.4 units on a scale
Standard Error 2.75
|
-20.7 units on a scale
Standard Error 3.01
|
|
Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score
End of Treatment (N=58, 60, 53)
|
-21.7 units on a scale
Standard Error 2.71
|
-21.1 units on a scale
Standard Error 2.65
|
-22.4 units on a scale
Standard Error 2.84
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8 and 12Population: Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as "N"). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.
Quality of life was assessed by the ICIQ-LUTSqol questionnaire which consists of 19 questions regarding daily activities affected by urinary problems. Participants responded to each question on a scale from 1 (not at all) to 4 (a lot). The total symptom score ranges from 19 to 76, where larger scores correspond to a lesser quality of life). Least squares (LS) means were adjusted for pooled center and the Baseline value.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=44 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=39 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score
Week 4 (N=33, 36, 36)
|
-2.7 units on a scale
Standard Error 0.93
|
-2.4 units on a scale
Standard Error 0.88
|
-5.1 units on a scale
Standard Error 0.88
|
|
Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score
Week 8 (N=33, 32, 31)
|
-3.6 units on a scale
Standard Error 0.98
|
-4.3 units on a scale
Standard Error 0.99
|
-6.7 units on a scale
Standard Error 1.01
|
|
Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score
Week 12 (N=35, 33, 28)
|
-4.8 units on a scale
Standard Error 1.10
|
-6.5 units on a scale
Standard Error 1.12
|
-8.4 units on a scale
Standard Error 1.21
|
|
Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score
End of Treatment (N=39, 39, 38)
|
-4.7 units on a scale
Standard Error 1.05
|
-5.3 units on a scale
Standard Error 1.04
|
-7.3 units on a scale
Standard Error 1.05
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8 and 12Population: Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as "N"). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.
Participants were asked to rate how much their urinary symptoms interfered overall with their everyday life on a scale from 0 (not at all) to 10 (a great deal). Least squares (LS) means were adjusted for pooled center and the Baseline value.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=66 Participants
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=57 Participants
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score
Week 4 (N=57, 66, 56)
|
-1.2 units on a scale
Standard Error 0.29
|
-1.2 units on a scale
Standard Error 0.27
|
-1.3 units on a scale
Standard Error 0.29
|
|
Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score
Week 8 (N=56, 65, 55)
|
-1.7 units on a scale
Standard Error 0.29
|
-1.7 units on a scale
Standard Error 0.26
|
-1.8 units on a scale
Standard Error 0.29
|
|
Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score
Week 12 (N=56, 63, 55)
|
-2.1 units on a scale
Standard Error 0.28
|
-2.0 units on a scale
Standard Error 0.26
|
-2.2 units on a scale
Standard Error 0.28
|
|
Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score
End of Treatment (N=60, 66, 57)
|
-2.0 units on a scale
Standard Error 0.28
|
-1.9 units on a scale
Standard Error 0.26
|
-2.1 units on a scale
Standard Error 0.29
|
Adverse Events
Placebo
6 mg Solifenacin + 0.4 mg Tamsulosin
9 mg Solifenacin + 0.4 mg Tamsulosin
Serious adverse events
| Measure |
Placebo
n=74 participants at risk
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=74 participants at risk
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=74 participants at risk
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
1.4%
1/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
0.00%
0/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
1.4%
1/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
0.00%
0/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
|
Infections and infestations
Urethritis
|
1.4%
1/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
0.00%
0/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
0.00%
0/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
0.00%
0/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
1.4%
1/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
0.00%
0/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
1.4%
1/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
1.4%
1/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
0.00%
0/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
|
Reproductive system and breast disorders
Prostatitis
|
1.4%
1/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
0.00%
0/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
0.00%
0/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
Other adverse events
| Measure |
Placebo
n=74 participants at risk
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
|
6 mg Solifenacin + 0.4 mg Tamsulosin
n=74 participants at risk
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
9 mg Solifenacin + 0.4 mg Tamsulosin
n=74 participants at risk
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
|
|---|---|---|---|
|
Eye disorders
Vision blurred
|
1.4%
1/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
1.4%
1/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
5.4%
4/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
4.1%
3/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
8.1%
6/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
|
Gastrointestinal disorders
Dry mouth
|
4.1%
3/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
12.2%
9/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
18.9%
14/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
|
General disorders
Fatigue
|
2.7%
2/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
5.4%
4/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
0.00%
0/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
|
Nervous system disorders
Dizziness
|
4.1%
3/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
1.4%
1/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
5.4%
4/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
|
Nervous system disorders
Headache
|
8.1%
6/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
4.1%
3/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
2.7%
2/74 • From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
|
Additional Information
Senior Medical Director, Medical Affairs
Astellas Pharma Global Development, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site only after Sponsor's prior written consent.
- Publication restrictions are in place
Restriction type: OTHER