A Phase 2 interventional study of solifenacin succinate and tamsulosin hydrochloride in Lower Urinary Tract Symptoms and Bladder Outlet Obstruction, sponsored by Astellas Pharma Inc. Completed at 33 sites in 6 countries. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2014-08-06.
Sponsored by Astellas Pharma Inc · Phase 2, Interventional, and Treatment
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).
416 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
This study's enrollment of 222 is above the median of 100 across 272 interventional studies indexed under Lower Urinary Tract Symptoms.
Browse Lower Urinary Tract Symptoms studies →Astellas Pharma Inc is the lead sponsor of 525 studies on the registry; 4 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 19 (68%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
Drug: Placebo to solifenacin · Drug: Placebo to tamsulosin
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
Drug: solifenacin succinate · Drug: tamsulosin hydrochloride
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
Drug: solifenacin succinate · Drug: tamsulosin hydrochloride
Solifenacin succinate tablets
Also known as: YM905, VESIcare
Tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets
Also known as: Omnic Ocas, Flomax CR
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
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
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
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
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
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).
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Started | 74 | 74 | 74 |
| Completed | 62 | 68 | 62 |
| Not completed | 12 | 6 | 12 |
| Withdrew: Adverse event | 3 | 3 | 6 |
| Withdrew: Withdrawal by subject | 2 | 1 | 2 |
| Withdrew: Protocol violation | 4 | 1 | 1 |
| Withdrew: Lost to follow-up | 2 | 0 | 2 |
| Withdrew: Lack of efficacy | 0 | 1 | 0 |
| Withdrew: Other - miscellaneous reason | 1 | 0 | 1 |
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.
| cmH2O | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax) | -1.69 ± 3.15 | -7.84 ± 2.95 | -6.69 ± 3.20 |
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.
| mL | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Week 2 (N=61, 67, 58) | -10.21 ± 6.912 | 16.78 ± 6.525 | 8.97 ± 7.015 |
| Week 4 (N=60, 67, 59) | -7.86 ± 6.225 | 14.92 ± 5.830 | 9.65 ± 6.229 |
| Week 8 (N=58, 66, 58) | -12.44 ± 6.434 | 9.64 ± 5.950 | 6.64 ± 6.373 |
| Week 12 (N=57, 63, 57) | 1.16 ± 7.346 | 26.81 ± 6.843 | 18.72 ± 7.244 |
| End of Treatment (N=62, 67, 59) | 0.14 ± 6.809 | 25.63 ± 6.477 | 19.07 ± 6.923 |
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.
| mL/sec | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) | 0.17 ± 0.43 | 1.85 ± 0.41 | 2.35 ± 0.43 |
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.
| units on a scale | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Change From Baseline to End of Treatment in Bladder Contractility Index (BCI) | -1.63 ± 3.705 | 1.84 ± 3.475 | 3.86 ± 3.764 |
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.
| Percent voiding efficiency | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE) | -0.67 ± 2.757 | -1.38 ± 2.634 | -3.79 ± 2.812 |
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.
| participants | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Any adverse event | 29 | 38 | 37 |
| Mild adverse event | 21 | 21 | 20 |
| Moderate adverse event | 6 | 13 | 12 |
| Severe adverse event | 2 | 4 | 5 |
| Serious adverse event | 1 | 2 | 2 |
| AE leading to study drug discontinuation | 3 | 3 | 6 |
| Drug-related adverse events | 15 | 24 | 26 |
| Deaths | 0 | 0 | 0 |
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.
| units on a scale | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Week 2 (N=61, 67, 58) | -3.8 ± 0.58 | -4.5 ± 0.54 | -4.7 ± 0.59 |
| Week 4 (N=60, 65, 57) | -5.3 ± 0.63 | -6.4 ± 0.59 | -6.2 ± 0.64 |
| Week 8 (N=58, 67, 57) | -6.8 ± 0.74 | -7.1 ± 0.68 | -6.9 ± 0.74 |
| Week 12 (N=58, 63, 57) | -6.9 ± 0.66 | -7.9 ± 0.62 | -7.2 ± 0.66 |
| End of Treatment (N=62, 67, 59) | -6.6 ± 0.65 | -8.0 ± 0.62 | -6.9 ± 0.66 |
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.
| units on a scale | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Week 2 (N=61, 67, 58) | -2.2 ± 0.39 | -2.9 ± 0.37 | -2.6 ± 0.40 |
| Week 4 (N=60, 65, 57) | -3.2 ± 0.45 | -3.8 ± 0.42 | -3.6 ± 0.46 |
| Week 8 (N=58, 67, 57) | -4.1 ± 0.49 | -4.3 ± 0.45 | -3.8 ± 0.49 |
| Week 12 (N=58, 64, 57) | -4.0 ± 0.45 | -4.7 ± 0.42 | -4.1 ± 0.45 |
| End of Treatment (N=62, 67, 59) | -3.9 ± 0.44 | -4.6 ± 0.42 | -3.9 ± 0.45 |
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.
| units on a scale | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Week 2 (N=62, 67, 58) | -1.5 ± 0.29 | -1.6 ± 0.27 | -2.1 ± 0.29 |
| Week 4 (N=60, 66, 58) | -2.1 ± 0.30 | -2.6 ± 0.28 | -2.5 ± 0.30 |
| Week 8 (N=58, 67, 58) | -2.7 ± 0.34 | -2.8 ± 0.31 | -3.1 ± 0.33 |
| Week 12 (N=58, 63, 57) | -2.8 ± 0.30 | -3.3 ± 0.29 | -3.1 ± 0.30 |
| End of Treatment (N=62, 67, 59) | -2.7 ± 0.30 | -3.4 ± 0.28 | -3.0 ± 0.30 |
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.
| units on a scale | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Week 2 (N=61, 66, 58) | -0.5 ± 0.12 | -0.3 ± 0.11 | -0.5 ± 0.12 |
| Week 4 (N=60, 66, 58) | -0.7 ± 0.13 | -0.5 ± 0.12 | -0.9 ± 0.13 |
| Week 8 (N=58, 67, 58) | -1.0 ± 0.14 | -0.8 ± 0.13 | -1.1 ± 0.14 |
| Week 12 (N=58, 64, 57) | -1.1 ± 0.14 | -1.0 ± 0.13 | -1.1 ± 0.14 |
| End of Treatment (N=62, 67, 59) | -1.1 ± 0.13 | -0.9 ± 0.13 | -1.1 ± 0.14 |
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.
| micturitions | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Week 2 (N=60, 67, 59) | -0.44 ± 0.261 | -1.25 ± 0.243 | -1.19 ± 0.261 |
| Week 4 (N=60, 65, 58) | -1.03 ± 0.285 | -1.32 ± 0.270 | -1.72 ± 0.287 |
| Week 8 (N=58, 67, 58) | -1.33 ± 0.330 | -1.31 ± 0.302 | -2.00 ± 0.327 |
| Week 12 (N=58, 65, 58) | -1.07 ± 0.333 | -1.91 ± 0.309 | -1.89 ± 0.330 |
| End of Treatment (N=60, 67, 59) | -0.95 ± 0.328 | -1.91 ± 0.306 | -1.87 ± 0.328 |
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.
| urgency episodes | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Week 2 (N=60, 67, 59) | -0.59 ± 0.246 | -0.89 ± 0.230 | -0.95 ± 0.246 |
| Week 4 (N=60, 65, 58) | -1.18 ± 0.254 | -1.39 ± 0.240 | -1.34 ± 0.255 |
| Week 8 (N=58, 67, 58) | -1.45 ± 0.263 | -1.34 ± 0.241 | -1.08 ± 0.261 |
| Week 12 (N=58, 65, 58) | -1.47 ± 0.247 | -1.54 ± 0.230 | -1.18 ± 0.245 |
| End of Treatment (N=60, 67, 59) | -1.41 ± 0.249 | -1.45 ± 0.232 | -1.23 ± 0.249 |
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.
| incontinence episodes | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Week 2 (N=13, 10, 13) | -0.81 ± 0.368 | -1.45 ± 0.412 | -1.01 ± 0.352 |
| Week 4 (N=13, 10, 13) | -1.00 ± 0.533 | -1.45 ± 0.596 | -0.81 ± 0.508 |
| Week 8 (N=12, 10, 12) | -1.86 ± 0.489 | -1.55 ± 0.508 | -0.78 ± 0.453 |
| Week 12 (N=12, 9, 12) | -1.99 ± 0.600 | -1.48 ± 0.654 | -0.85 ± 0.551 |
| End of Treatment (N=13, 10, 13) | -1.54 ± 0.571 | -1.66 ± 0.639 | -1.02 ± 0.545 |
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.
| mL | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Week 2 (N=60, 67, 59) | 9.36 ± 4.415 | 31.46 ± 4.109 | 18.25 ± 4.408 |
| Week 4 (N=60, 65, 58) | 10.40 ± 5.207 | 35.27 ± 4.920 | 30.34 ± 5.236 |
| Week 8 (N=58, 67, 58) | 10.50 ± 6.125 | 33.72 ± 5.596 | 35.53 ± 6.064 |
| Week 12 (N=58, 65, 58) | 9.03 ± 5.703 | 35.02 ± 5.283 | 31.18 ± 5.643 |
| End of Treatment (N=60, 67, 59) | 7.56 ± 5.700 | 36.26 ± 5.305 | 30.33 ± 5.691 |
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.
| units on a scale | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Week 4 (N=58, 66, 52) | -3.9 ± 0.60 | -4.5 ± 0.56 | -4.6 ± 0.64 |
| Week 8 (N=55, 63, 53) | -5.5 ± 0.68 | -5.6 ± 0.63 | -5.8 ± 0.70 |
| Week 12 (N=55, 61, 53) | -5.5 ± 0.70 | -6.5 ± 0.66 | -5.9 ± 0.71 |
| End of Treatment (N=60, 66, 57) | -5.2 ± 0.69 | -6.0 ± 0.65 | -5.8 ± 0.71 |
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.
| units on a scale | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Week 4 (N=52, 57, 48) | -14.6 ± 2.76 | -11.0 ± 2.62 | -17.0 ± 2.88 |
| Week 8 (N=51, 55, 47) | -20.7 ± 2.88 | -19.4 ± 2.75 | -20.7 ± 3.01 |
| Week 12 (N=51, 51, 47) | -22.6 ± 2.78 | -23.9 ± 2.74 | -23.9 ± 2.91 |
| End of Treatment (N=58, 60, 53) | -21.7 ± 2.71 | -21.1 ± 2.65 | -22.4 ± 2.84 |
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.
| units on a scale | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Week 4 (N=33, 36, 36) | -2.7 ± 0.93 | -2.4 ± 0.88 | -5.1 ± 0.88 |
| Week 8 (N=33, 32, 31) | -3.6 ± 0.98 | -4.3 ± 0.99 | -6.7 ± 1.01 |
| Week 12 (N=35, 33, 28) | -4.8 ± 1.10 | -6.5 ± 1.12 | -8.4 ± 1.21 |
| End of Treatment (N=39, 39, 38) | -4.7 ± 1.05 | -5.3 ± 1.04 | -7.3 ± 1.05 |
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.
| units on a scale | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Week 4 (N=57, 66, 56) | -1.2 ± 0.29 | -1.2 ± 0.27 | -1.3 ± 0.29 |
| Week 8 (N=56, 65, 55) | -1.7 ± 0.29 | -1.7 ± 0.26 | -1.8 ± 0.29 |
| Week 12 (N=56, 63, 55) | -2.1 ± 0.28 | -2.0 ± 0.26 | -2.2 ± 0.28 |
| End of Treatment (N=60, 66, 57) | -2.0 ± 0.28 | -1.9 ± 0.26 | -2.1 ± 0.29 |
Collected over From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 1/74 (1.4%) | 10/74 (13.5%) |
| 6 mg Solifenacin + 0.4 mg Tamsulosin | — | 2/74 (2.7%) | 17/74 (23%) |
| 9 mg Solifenacin + 0.4 mg Tamsulosin | — | 2/74 (2.7%) | 19/74 (25.7%) |
| Event | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Myocardial infarctionCardiac disorders | 0/74 | 1/74 | 0/74 |
| ConstipationGastrointestinal disorders | 0/74 | 1/74 | 0/74 |
| UrethritisInfections and infestations | 1/74 | 0/74 | 0/74 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/74 | 0/74 | 1/74 |
| Accidental overdoseInjury, poisoning and procedural complications | 0/74 | 0/74 | 1/74 |
| Urinary retentionRenal and urinary disorders | 0/74 | 1/74 | 0/74 |
| ProstatitisReproductive system and breast disorders | 1/74 | 0/74 | 0/74 |
| Event | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin |
|---|---|---|---|
| Dry mouthGastrointestinal disorders | 3/74 | 9/74 | 14/74 |
| ConstipationGastrointestinal disorders | 1/74 | 3/74 | 6/74 |
| HeadacheNervous system disorders | 6/74 | 3/74 | 2/74 |
| Vision blurredEye disorders | 1/74 | 1/74 | 4/74 |
| FatigueGeneral disorders | 2/74 | 4/74 | 0/74 |
| DizzinessNervous system disorders | 3/74 | 1/74 | 4/74 |
| Age, Continuous(years) | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin | Total |
|---|---|---|---|---|
| Mean | 64.3 ± 7.60 | 63.8 ± 8.43 | 65.6 ± 8.26 | 64.6 ± 8.11 |
| Sex: Female, Male(Participants) | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 74 | 74 | 74 | 222 |
| Race/Ethnicity, Customized(participants) | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin | Total |
|---|---|---|---|---|
| White | 71 | 74 | 69 | 214 |
| Black or African-American | 2 | 0 | 2 | 4 |
| Asian | 1 | 0 | 1 | 2 |
| Other | 0 | 0 | 2 | 2 |
| Race/Ethnicity, Customized(participants) | Placebo | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 mg Solifenacin + 0.4 mg Tamsulosin | Total |
|---|---|---|---|---|
| Non Hispanic or Latino | 72 | 71 | 69 | 212 |
| Hispanic or Latino | 2 | 3 | 5 | 10 |
The record gives a start of Jun 2007, a primary completion of Aug 2008 and a completion of Aug 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2014, 6 years after primary completion. A results delay was requested in Sep 2009.
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Studies of the drugs tested here: Solifenacin · Tamsulosin
Lower Urinary Tract Symptoms →