Lower Urinary Tract Symptoms, Bladder Outlet Obstruction
Conditions
Keywords
Lower Urinary Tract Symptoms, Bladder Outlet Obstruction, Treatment, Solifenacin Succinate, Tamsulosin hydrochloride
Brief summary
A study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in men with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).
Interventions
DRUGsolifenacin succinate
Solifenacin succinate tablets
Tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets
DRUGPlacebo to solifenacin
DRUGPlacebo to tamsulosin
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO) * BOO indication by a Bladder Outlet Obstruction Index (BOOI) ≥ 20 * Patient has a total International Prostate Symptom Score (IPPS) score of ≥ 8 (Inclusion criteria for Baseline also) * Patient had a maximum urinary flow rate of ≤ 12 mL/sec, with a voided volume of ≥ 120 mL during free flow in a representative assessment of uroflowmetry.
Exclusion criteria
* History of urinary retention in preceding 12 months * Current urinary tract infection (UTI) or symptomatic and recurrent UTI of \> 3 episodes within 12 months. * Known clinical history or diagnosis of chronic inflammation, stone in bladder or ureter, or other causes of outflow tract obstruction * Known diagnosis or history of carcinoma or previous pelvic radiation therapy, except non-metastatic basal or squamous cell carcinoma of the skin that had been treated successfully * Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Visit 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax) | Baseline and Week 12 | 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. |
| Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) | Baseline and Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE) | Baseline and Week 12 | 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. |
| Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks). | 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. |
| Change From Baseline in International Prostate Symptoms Score (IPSS) | Baseline and Weeks 2, 4, 8 and 12 | 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. |
| Change From Baseline in IPSS Voiding Score | Baseline and Weeks 2, 4, 8 and 12 | 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. |
| Change From Baseline in IPSS Storage Score | Baseline and Weeks 2, 4, 8 and 12 | 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. |
| Change From Baseline in Patient Perception of Bladder Condition (PPBC) | Baseline and Weeks 2, 4, 8 and 12 | 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. |
| Change From Baseline in Number of Micturitions Per 24 Hours | Baseline and Weeks 2, 4, 8 and 12 | 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. |
| Change From Baseline in Post Void Residual Volume (PVR) | Baseline and Weeks 2, 4, 8 and 12 | 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. |
| Change From Baseline in Number of Incontinence Episodes Per 24 Hours | Baseline and Weeks 2, 4, 8 and 12 | 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. |
| Change From Baseline in Volume Voided Per Micturition | Baseline and Weeks 2, 4, 8 and 12 | 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. |
| Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score | Baseline and Weeks 4, 8 and 12 | 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. |
| Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score | Baseline and Weeks 4, 8 and 12 | 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. |
| Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score | Baseline and Weeks 4, 8 and 12 | 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. |
| Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score | Baseline and Weeks 4, 8 and 12 | 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. |
| Change From Baseline in Number of Urgency Episodes Per 24 Hours | Baseline and Weeks 2, 4, 8 and 12 | 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. |
| Change From Baseline to End of Treatment in Bladder Contractility Index (BCI) | Baseline and Week 12 | 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. |
Countries
Belgium, Czechia, Germany, Hungary, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks. | 74 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks. | 74 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks. | 74 |
| Total | 222 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 | 6 |
| Overall Study | Lack of Efficacy | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 | 2 |
| Overall Study | Other - miscellaneous reason | 1 | 0 | 1 |
| Overall Study | Protocol Violation | 4 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 2 |
Baseline characteristics
| Characteristic | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin | Total |
|---|---|---|---|---|
| Age, Continuous | 64.3 years STANDARD_DEVIATION 7.6 | 63.8 years STANDARD_DEVIATION 8.43 | 65.6 years STANDARD_DEVIATION 8.26 | 64.6 years STANDARD_DEVIATION 8.11 |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Black or African-American | 2 participants | 0 participants | 2 participants | 4 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 participants | 3 participants | 5 participants | 10 participants |
| Race/Ethnicity, Customized Non Hispanic or Latino | 72 participants | 71 participants | 69 participants | 212 participants |
| Race/Ethnicity, Customized Other | 0 participants | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized White | 71 participants | 74 participants | 69 participants | 214 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 74 Participants | 74 Participants | 74 Participants | 222 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 74 | 17 / 74 | 19 / 74 |
| serious Total, serious adverse events | 1 / 74 | 2 / 74 | 2 / 74 |
Outcome results
Primary
Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax) | -1.69 cmH2O | Standard Error 3.15 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax) | -7.84 cmH2O | Standard Error 2.95 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax) | -6.69 cmH2O | Standard Error 3.2 |
Comparison: A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.95% CI: [-14.67, 2.37]
Comparison: A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.95% CI: [-13.85, 3.84]
Primary
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) | 0.17 mL/sec | Standard Error 0.43 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) | 1.85 mL/sec | Standard Error 0.41 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) | 2.35 mL/sec | Standard Error 0.43 |
Comparison: A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.95% CI: [0.5, 2.85]
Comparison: A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.95% CI: [0.98, 3.37]
Secondary
Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score
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.
Time frame: Baseline and Weeks 4, 8 and 12
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score | End of Treatment (N=60, 66, 57) | -1.9 units on a scale | Standard Error 0.26 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | 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 0.27 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score | Week 12 (N=56, 63, 55) | -2.0 units on a scale | Standard Error 0.26 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | 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 0.26 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score | End of Treatment (N=60, 66, 57) | -2.1 units on a scale | Standard Error 0.29 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score | Week 8 (N=56, 65, 55) | -1.8 units on a scale | Standard Error 0.29 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score | Week 12 (N=56, 63, 55) | -2.2 units on a scale | Standard Error 0.28 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score | Week 4 (N=57, 66, 56) | -1.3 units on a scale | Standard Error 0.29 |
Secondary
Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score
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.
Time frame: Baseline and Weeks 4, 8 and 12
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score | End of Treatment (N=58, 60, 53) | -21.1 units on a scale | Standard Error 2.65 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score | Week 4 (N=52, 57, 48) | -11.0 units on a scale | Standard Error 2.62 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score | Week 12 (N=51, 51, 47) | -23.9 units on a scale | Standard Error 2.74 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score | Week 8 (N=51, 55, 47) | -19.4 units on a scale | Standard Error 2.75 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score | End of Treatment (N=58, 60, 53) | -22.4 units on a scale | Standard Error 2.84 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score | Week 8 (N=51, 55, 47) | -20.7 units on a scale | Standard Error 3.01 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score | Week 12 (N=51, 51, 47) | -23.9 units on a scale | Standard Error 2.91 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score | Week 4 (N=52, 57, 48) | -17.0 units on a scale | Standard Error 2.88 |
Secondary
Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score
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.
Time frame: Baseline and Weeks 4, 8 and 12
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 1.1 |
| Placebo | 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 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | 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) | -5.3 units on a scale | Standard Error 1.04 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | 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) | -2.4 units on a scale | Standard Error 0.88 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | 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) | -6.5 units on a scale | Standard Error 1.12 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | 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) | -4.3 units on a scale | Standard Error 0.99 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | 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) | -7.3 units on a scale | Standard Error 1.05 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | 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) | -6.7 units on a scale | Standard Error 1.01 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | 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) | -8.4 units on a scale | Standard Error 1.21 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | 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) | -5.1 units on a scale | Standard Error 0.88 |
Secondary
Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score
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.
Time frame: Baseline and Weeks 4, 8 and 12
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 0.6 |
| Placebo | 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 |
| Placebo | 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 0.7 |
| Placebo | 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 mg Solifenacin + 0.4 mg Tamsulosin | 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) | -6.0 units on a scale | Standard Error 0.65 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | 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) | -4.5 units on a scale | Standard Error 0.56 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | 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) | -6.5 units on a scale | Standard Error 0.66 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | 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) | -5.6 units on a scale | Standard Error 0.63 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | 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) | -5.8 units on a scale | Standard Error 0.71 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | 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) | -5.8 units on a scale | Standard Error 0.7 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | 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) | -5.9 units on a scale | Standard Error 0.71 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | 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) | -4.6 units on a scale | Standard Error 0.64 |
Secondary
Change From Baseline in International Prostate Symptoms Score (IPSS)
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.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in International Prostate Symptoms Score (IPSS) | Week 8 (N=58, 67, 57) | -7.1 units on a scale | Standard Error 0.68 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in International Prostate Symptoms Score (IPSS) | Week 2 (N=61, 67, 58) | -4.5 units on a scale | Standard Error 0.54 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in International Prostate Symptoms Score (IPSS) | Week 4 (N=60, 65, 57) | -6.4 units on a scale | Standard Error 0.59 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in International Prostate Symptoms Score (IPSS) | Week 12 (N=58, 63, 57) | -7.9 units on a scale | Standard Error 0.62 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in International Prostate Symptoms Score (IPSS) | End of Treatment (N=62, 67, 59) | -8.0 units on a scale | Standard Error 0.62 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in International Prostate Symptoms Score (IPSS) | End of Treatment (N=62, 67, 59) | -6.9 units on a scale | Standard Error 0.66 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in International Prostate Symptoms Score (IPSS) | Week 12 (N=58, 63, 57) | -7.2 units on a scale | Standard Error 0.66 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in International Prostate Symptoms Score (IPSS) | Week 2 (N=61, 67, 58) | -4.7 units on a scale | Standard Error 0.59 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in International Prostate Symptoms Score (IPSS) | Week 8 (N=58, 67, 57) | -6.9 units on a scale | Standard Error 0.74 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in International Prostate Symptoms Score (IPSS) | Week 4 (N=60, 65, 57) | -6.2 units on a scale | Standard Error 0.64 |
Secondary
Change From Baseline in IPSS Storage Score
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.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in IPSS Storage Score | Week 12 (N=58, 63, 57) | -2.8 units on a scale | Standard Error 0.3 |
| Placebo | Change From Baseline in IPSS Storage Score | Week 8 (N=58, 67, 58) | -2.7 units on a scale | Standard Error 0.34 |
| Placebo | Change From Baseline in IPSS Storage Score | Week 2 (N=62, 67, 58) | -1.5 units on a scale | Standard Error 0.29 |
| Placebo | Change From Baseline in IPSS Storage Score | Week 4 (N=60, 66, 58) | -2.1 units on a scale | Standard Error 0.3 |
| Placebo | Change From Baseline in IPSS Storage Score | End of Treatment (N=62, 67, 59) | -2.7 units on a scale | Standard Error 0.3 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Storage Score | Week 8 (N=58, 67, 58) | -2.8 units on a scale | Standard Error 0.31 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Storage Score | Week 2 (N=62, 67, 58) | -1.6 units on a scale | Standard Error 0.27 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Storage Score | Week 4 (N=60, 66, 58) | -2.6 units on a scale | Standard Error 0.28 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Storage Score | Week 12 (N=58, 63, 57) | -3.3 units on a scale | Standard Error 0.29 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Storage Score | End of Treatment (N=62, 67, 59) | -3.4 units on a scale | Standard Error 0.28 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Storage Score | End of Treatment (N=62, 67, 59) | -3.0 units on a scale | Standard Error 0.3 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Storage Score | Week 12 (N=58, 63, 57) | -3.1 units on a scale | Standard Error 0.3 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Storage Score | Week 2 (N=62, 67, 58) | -2.1 units on a scale | Standard Error 0.29 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Storage Score | Week 8 (N=58, 67, 58) | -3.1 units on a scale | Standard Error 0.33 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Storage Score | Week 4 (N=60, 66, 58) | -2.5 units on a scale | Standard Error 0.3 |
Secondary
Change From Baseline in IPSS Voiding Score
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.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in IPSS Voiding Score | Week 12 (N=58, 64, 57) | -4.0 units on a scale | Standard Error 0.45 |
| Placebo | Change From Baseline in IPSS Voiding Score | Week 8 (N=58, 67, 57) | -4.1 units on a scale | Standard Error 0.49 |
| Placebo | Change From Baseline in IPSS Voiding Score | Week 2 (N=61, 67, 58) | -2.2 units on a scale | Standard Error 0.39 |
| Placebo | Change From Baseline in IPSS Voiding Score | Week 4 (N=60, 65, 57) | -3.2 units on a scale | Standard Error 0.45 |
| Placebo | Change From Baseline in IPSS Voiding Score | End of Treatment (N=62, 67, 59) | -3.9 units on a scale | Standard Error 0.44 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Voiding Score | Week 8 (N=58, 67, 57) | -4.3 units on a scale | Standard Error 0.45 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Voiding Score | Week 2 (N=61, 67, 58) | -2.9 units on a scale | Standard Error 0.37 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Voiding Score | Week 4 (N=60, 65, 57) | -3.8 units on a scale | Standard Error 0.42 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Voiding Score | Week 12 (N=58, 64, 57) | -4.7 units on a scale | Standard Error 0.42 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Voiding Score | End of Treatment (N=62, 67, 59) | -4.6 units on a scale | Standard Error 0.42 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Voiding Score | End of Treatment (N=62, 67, 59) | -3.9 units on a scale | Standard Error 0.45 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Voiding Score | Week 12 (N=58, 64, 57) | -4.1 units on a scale | Standard Error 0.45 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Voiding Score | Week 2 (N=61, 67, 58) | -2.6 units on a scale | Standard Error 0.4 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Voiding Score | Week 8 (N=58, 67, 57) | -3.8 units on a scale | Standard Error 0.49 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in IPSS Voiding Score | Week 4 (N=60, 65, 57) | -3.6 units on a scale | Standard Error 0.46 |
Secondary
Change From Baseline in Number of Incontinence Episodes Per 24 Hours
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.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Number of Incontinence Episodes Per 24 Hours | Week 12 (N=12, 9, 12) | -1.99 incontinence episodes | Standard Error 0.6 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Incontinence Episodes Per 24 Hours | Week 8 (N=12, 10, 12) | -1.55 incontinence episodes | Standard Error 0.508 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Incontinence Episodes Per 24 Hours | Week 2 (N=13, 10, 13) | -1.45 incontinence episodes | Standard Error 0.412 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Incontinence Episodes Per 24 Hours | Week 4 (N=13, 10, 13) | -1.45 incontinence episodes | Standard Error 0.596 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Incontinence Episodes Per 24 Hours | Week 12 (N=12, 9, 12) | -1.48 incontinence episodes | Standard Error 0.654 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Incontinence Episodes Per 24 Hours | End of Treatment (N=13, 10, 13) | -1.66 incontinence episodes | Standard Error 0.639 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Incontinence Episodes Per 24 Hours | End of Treatment (N=13, 10, 13) | -1.02 incontinence episodes | Standard Error 0.545 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Incontinence Episodes Per 24 Hours | Week 12 (N=12, 9, 12) | -0.85 incontinence episodes | Standard Error 0.551 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Incontinence Episodes Per 24 Hours | Week 2 (N=13, 10, 13) | -1.01 incontinence episodes | Standard Error 0.352 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Incontinence Episodes Per 24 Hours | Week 8 (N=12, 10, 12) | -0.78 incontinence episodes | Standard Error 0.453 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Incontinence Episodes Per 24 Hours | Week 4 (N=13, 10, 13) | -0.81 incontinence episodes | Standard Error 0.508 |
Secondary
Change From Baseline in Number of Micturitions Per 24 Hours
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.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Number of Micturitions Per 24 Hours | Week 12 (N=58, 65, 58) | -1.07 micturitions | Standard Error 0.333 |
| Placebo | Change From Baseline in Number of Micturitions Per 24 Hours | Week 8 (N=58, 67, 58) | -1.33 micturitions | Standard Error 0.33 |
| Placebo | Change From Baseline in Number of Micturitions Per 24 Hours | Week 2 (N=60, 67, 59) | -0.44 micturitions | Standard Error 0.261 |
| Placebo | Change From Baseline in Number of Micturitions Per 24 Hours | Week 4 (N=60, 65, 58) | -1.03 micturitions | Standard Error 0.285 |
| Placebo | Change From Baseline in Number of Micturitions Per 24 Hours | End of Treatment (N=60, 67, 59) | -0.95 micturitions | Standard Error 0.328 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Micturitions Per 24 Hours | Week 8 (N=58, 67, 58) | -1.31 micturitions | Standard Error 0.302 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Micturitions Per 24 Hours | Week 2 (N=60, 67, 59) | -1.25 micturitions | Standard Error 0.243 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Micturitions Per 24 Hours | Week 4 (N=60, 65, 58) | -1.32 micturitions | Standard Error 0.27 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Micturitions Per 24 Hours | Week 12 (N=58, 65, 58) | -1.91 micturitions | Standard Error 0.309 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Micturitions Per 24 Hours | End of Treatment (N=60, 67, 59) | -1.91 micturitions | Standard Error 0.306 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Micturitions Per 24 Hours | End of Treatment (N=60, 67, 59) | -1.87 micturitions | Standard Error 0.328 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Micturitions Per 24 Hours | Week 12 (N=58, 65, 58) | -1.89 micturitions | Standard Error 0.33 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Micturitions Per 24 Hours | Week 2 (N=60, 67, 59) | -1.19 micturitions | Standard Error 0.261 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Micturitions Per 24 Hours | Week 8 (N=58, 67, 58) | -2.00 micturitions | Standard Error 0.327 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Micturitions Per 24 Hours | Week 4 (N=60, 65, 58) | -1.72 micturitions | Standard Error 0.287 |
Secondary
Change From Baseline in Number of Urgency Episodes Per 24 Hours
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.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Urgency Episodes Per 24 Hours | Week 8 (N=58, 67, 58) | -1.34 urgency episodes | Standard Error 0.241 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Urgency Episodes Per 24 Hours | Week 2 (N=60, 67, 59) | -0.89 urgency episodes | Standard Error 0.23 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Urgency Episodes Per 24 Hours | Week 4 (N=60, 65, 58) | -1.39 urgency episodes | Standard Error 0.24 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Urgency Episodes Per 24 Hours | Week 12 (N=58, 65, 58) | -1.54 urgency episodes | Standard Error 0.23 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Urgency Episodes Per 24 Hours | End of Treatment (N=60, 67, 59) | -1.45 urgency episodes | Standard Error 0.232 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Urgency Episodes Per 24 Hours | End of Treatment (N=60, 67, 59) | -1.23 urgency episodes | Standard Error 0.249 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Urgency Episodes Per 24 Hours | Week 12 (N=58, 65, 58) | -1.18 urgency episodes | Standard Error 0.245 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Urgency Episodes Per 24 Hours | Week 2 (N=60, 67, 59) | -0.95 urgency episodes | Standard Error 0.246 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Urgency Episodes Per 24 Hours | Week 8 (N=58, 67, 58) | -1.08 urgency episodes | Standard Error 0.261 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Number of Urgency Episodes Per 24 Hours | Week 4 (N=60, 65, 58) | -1.34 urgency episodes | Standard Error 0.255 |
Secondary
Change From Baseline in Patient Perception of Bladder Condition (PPBC)
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.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Patient Perception of Bladder Condition (PPBC) | Week 8 (N=58, 67, 58) | -0.8 units on a scale | Standard Error 0.13 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Patient Perception of Bladder Condition (PPBC) | Week 2 (N=61, 66, 58) | -0.3 units on a scale | Standard Error 0.11 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Patient Perception of Bladder Condition (PPBC) | Week 4 (N=60, 66, 58) | -0.5 units on a scale | Standard Error 0.12 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Patient Perception of Bladder Condition (PPBC) | Week 12 (N=58, 64, 57) | -1.0 units on a scale | Standard Error 0.13 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Patient Perception of Bladder Condition (PPBC) | End of Treatment (N=62, 67, 59) | -0.9 units on a scale | Standard Error 0.13 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | 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 0.14 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | 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 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | 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 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Patient Perception of Bladder Condition (PPBC) | Week 8 (N=58, 67, 58) | -1.1 units on a scale | Standard Error 0.14 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Patient Perception of Bladder Condition (PPBC) | Week 4 (N=60, 66, 58) | -0.9 units on a scale | Standard Error 0.13 |
Secondary
Change From Baseline in Post Void Residual Volume (PVR)
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.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Post Void Residual Volume (PVR) | Week 12 (N=57, 63, 57) | 1.16 mL | Standard Error 7.346 |
| Placebo | Change From Baseline in Post Void Residual Volume (PVR) | Week 8 (N=58, 66, 58) | -12.44 mL | Standard Error 6.434 |
| Placebo | Change From Baseline in Post Void Residual Volume (PVR) | Week 2 (N=61, 67, 58) | -10.21 mL | Standard Error 6.912 |
| Placebo | Change From Baseline in Post Void Residual Volume (PVR) | Week 4 (N=60, 67, 59) | -7.86 mL | Standard Error 6.225 |
| Placebo | Change From Baseline in Post Void Residual Volume (PVR) | End of Treatment (N=62, 67, 59) | 0.14 mL | Standard Error 6.809 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Post Void Residual Volume (PVR) | Week 8 (N=58, 66, 58) | 9.64 mL | Standard Error 5.95 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Post Void Residual Volume (PVR) | Week 2 (N=61, 67, 58) | 16.78 mL | Standard Error 6.525 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Post Void Residual Volume (PVR) | Week 4 (N=60, 67, 59) | 14.92 mL | Standard Error 5.83 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Post Void Residual Volume (PVR) | Week 12 (N=57, 63, 57) | 26.81 mL | Standard Error 6.843 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Post Void Residual Volume (PVR) | End of Treatment (N=62, 67, 59) | 25.63 mL | Standard Error 6.477 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Post Void Residual Volume (PVR) | End of Treatment (N=62, 67, 59) | 19.07 mL | Standard Error 6.923 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Post Void Residual Volume (PVR) | Week 12 (N=57, 63, 57) | 18.72 mL | Standard Error 7.244 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Post Void Residual Volume (PVR) | Week 2 (N=61, 67, 58) | 8.97 mL | Standard Error 7.015 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Post Void Residual Volume (PVR) | Week 8 (N=58, 66, 58) | 6.64 mL | Standard Error 6.373 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Post Void Residual Volume (PVR) | Week 4 (N=60, 67, 59) | 9.65 mL | Standard Error 6.229 |
Secondary
Change From Baseline in Volume Voided Per Micturition
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.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Volume Voided Per Micturition | Week 12 (N=58, 65, 58) | 9.03 mL | Standard Error 5.703 |
| Placebo | Change From Baseline in Volume Voided Per Micturition | Week 8 (N=58, 67, 58) | 10.50 mL | Standard Error 6.125 |
| Placebo | Change From Baseline in Volume Voided Per Micturition | Week 2 (N=60, 67, 59) | 9.36 mL | Standard Error 4.415 |
| Placebo | Change From Baseline in Volume Voided Per Micturition | Week 4 (N=60, 65, 58) | 10.40 mL | Standard Error 5.207 |
| Placebo | Change From Baseline in Volume Voided Per Micturition | End of Treatment (N=60, 67, 59) | 7.56 mL | Standard Error 5.7 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Volume Voided Per Micturition | Week 8 (N=58, 67, 58) | 33.72 mL | Standard Error 5.596 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Volume Voided Per Micturition | Week 2 (N=60, 67, 59) | 31.46 mL | Standard Error 4.109 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Volume Voided Per Micturition | Week 4 (N=60, 65, 58) | 35.27 mL | Standard Error 4.92 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Volume Voided Per Micturition | Week 12 (N=58, 65, 58) | 35.02 mL | Standard Error 5.283 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Volume Voided Per Micturition | End of Treatment (N=60, 67, 59) | 36.26 mL | Standard Error 5.305 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Volume Voided Per Micturition | End of Treatment (N=60, 67, 59) | 30.33 mL | Standard Error 5.691 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Volume Voided Per Micturition | Week 12 (N=58, 65, 58) | 31.18 mL | Standard Error 5.643 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Volume Voided Per Micturition | Week 2 (N=60, 67, 59) | 18.25 mL | Standard Error 4.408 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Volume Voided Per Micturition | Week 8 (N=58, 67, 58) | 35.53 mL | Standard Error 6.064 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline in Volume Voided Per Micturition | Week 4 (N=60, 65, 58) | 30.34 mL | Standard Error 5.236 |
Secondary
Change From Baseline to End of Treatment in Bladder Contractility Index (BCI)
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.
Time frame: Baseline and Week 12
Population: Full analysis set (FAS) population; Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Treatment in Bladder Contractility Index (BCI) | -1.63 units on a scale | Standard Error 3.705 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline to End of Treatment in Bladder Contractility Index (BCI) | 1.84 units on a scale | Standard Error 3.475 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline to End of Treatment in Bladder Contractility Index (BCI) | 3.86 units on a scale | Standard Error 3.764 |
Secondary
Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE)
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.
Time frame: Baseline and Week 12
Population: Full analysis set (FAS) population; Last observation carried forward (LOCF) imputation was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE) | -0.67 Percent voiding efficiency | Standard Error 2.757 |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE) | -1.38 Percent voiding efficiency | Standard Error 2.634 |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE) | -3.79 Percent voiding efficiency | Standard Error 2.812 |
Secondary
Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Any adverse event | 29 participants |
| Placebo | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Mild adverse event | 21 participants |
| Placebo | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Moderate adverse event | 6 participants |
| Placebo | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Severe adverse event | 2 participants |
| Placebo | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Serious adverse event | 1 participants |
| Placebo | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | AE leading to study drug discontinuation | 3 participants |
| Placebo | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Drug-related adverse events | 15 participants |
| Placebo | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Deaths | 0 participants |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Moderate adverse event | 13 participants |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Drug-related adverse events | 24 participants |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Severe adverse event | 4 participants |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Serious adverse event | 2 participants |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | AE leading to study drug discontinuation | 3 participants |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Any adverse event | 38 participants |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Mild adverse event | 21 participants |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Deaths | 0 participants |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Moderate adverse event | 12 participants |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Mild adverse event | 20 participants |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Any adverse event | 37 participants |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Severe adverse event | 5 participants |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Drug-related adverse events | 26 participants |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | AE leading to study drug discontinuation | 6 participants |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Serious adverse event | 2 participants |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | Deaths | 0 participants |