A Phase 3 interventional study of tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg) and tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg) in Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, sponsored by Astellas Pharma Europe B.V.. Completed at 70 sites in 11 countries. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by Astellas Pharma Europe B.V. (part of Astellas Pharma Inc) · Phase 3, Interventional, and Treatment
Among 22 studies testing tamsulosin in Lower Urinary Tract Symptoms — 5 open to participants now, 5 under way, none of them phase 3. Tamsulosin · Lower Urinary Tract Symptoms.
Among the 22 studies testing tamsulosin in Lower Urinary Tract Symptoms, this one is the 3rd largest by enrollment, is one of 2 that started in 2010, is one of 3 in phase 3, and was the 4th registered.
416 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
This study's enrollment of 1,067 is above the median of 100 across 272 interventional studies indexed under Lower Urinary Tract Symptoms.
Browse Lower Urinary Tract Symptoms studies →5 of the 22 studies testing tamsulosin in Lower Urinary Tract Symptoms are open now, in 4 countries. Each count lists the studies.
Tamsulosin: first FDA approval 1997 (FLOMAX). What it is approved for, and how studies give it, is on its page →
Of the 59 Lower Urinary Tract Symptoms studies recruiting now, 39 (66%) set no upper age limit and 11 (19%) stop at 75 or younger; 7 take children under 18; 11 take healthy volunteers.
This study: 45 Years and older · male · no healthy volunteers.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2010.
Median enrollment 136 across the 22 interventional studies. Of the 17 that completed or were terminated, 8 (47%) have results posted.
9 of 22 have an industry lead sponsor. The 10 most frequent:
Astellas Pharma Europe B.V. is the lead sponsor of 94 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Astellas Pharma Europe B.V. has 3 studies filed under Lower Urinary Tract Symptoms — fewer than ten, so there is no comparison to draw.
1 of the studies testing tamsulosin in Lower Urinary Tract Symptoms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07722884Ain Shams UniversityTamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH | 2027-01-01 |
Among the 22 studies testing tamsulosin in Lower Urinary Tract Symptoms, from their registry updates:
Nothing recorded among them since 2026-09-25.
Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.
This is an open-label extension study following the double blind 905-CL-055 study
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:
Participants who received at least one dose of open-label fixed dose combination (FDC) treatment
Drug: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg) · Drug: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
Drug pages: Tamsulosin · Solifenacin
oral
Also known as: EC905, Vesomni
Drug pages: Tamsulosin · Solifenacin
oral
Also known as: EC905
Number of Participants With Adverse Events (AEs)
Safety is monitored by collecting AEs, which include abnormal lab parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A serious AE (SAE) was an AE resulting in death, persistent or significant disability/incapacity or congenital anomaly/birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity (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. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after the intake of first dose of double-blind study drug (if on FDC in 905-CL-055) or after first open-label dose until 30 days after the last dose of open-label study drug (in 905-CL-057).
Time frame: From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks)
Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume
PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
Qmax during a micturition (urination) was recorded using uroflowmetry.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Average Flow Rate (Qmean)
Qmean during a micturition (urination) was recorded using uroflowmetry.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS)
The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: • Incomplete emptying of the bladder • Intermittency • Weak stream • Hesitancy • Frequency • Urgency • Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic).
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS])
The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale: • 0. No urgency; • 1. Mild urgency; • 2. Moderate urgency; • 3. Severe urgency; • 4. Urgency incontinence TUS/TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Mean 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.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition
A micturition is any voluntary urination, excluding episodes of incontinence only. 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.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition
A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours
An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours
A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours
The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in IPSS Voiding Score
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. 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 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in IPSS Storage Score
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on 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 storage questions (frequency,urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score
The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Individual IPSS Scores
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: • Incomplete emptying of the bladder • Intermittency • Weak stream • Hesitancy • Frequency • Urgency • Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Symptom Bother Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6.The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline and up to 52 weeks of FDC treatment
Number of OAB-q Responders Based on Health-related Quality of Life: Total Score
A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Mobility Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed).
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Self-care Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress).
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities).
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain).
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious).
Time frame: Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score
Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).
Time frame: Baseline and up to 52 weeks of FDC treatment
Participants were eligible for Study 905-CL-057 if they completed 12 weeks of double-blind treatment in Study 905-CL-055, complied with inclusion criteria and did not meet any exclusion criteria. Participants treated with the FDC 0.4 mg/6 mg or 0.4 mg/9 mg for maximally 40 weeks.
| Milestone | Total Group |
|---|---|
| Started | 1066 |
| Safety analysis set (saf) | 1066 |
| Full analysis set (fas) | 1009 |
| Completed | 960 |
| Not completed | 106 |
| Withdrew: Not fulfilling incl./excl.criteria | 5 |
| Withdrew: Adverse event | 43 |
| Withdrew: Lack of efficacy | 19 |
| Withdrew: Withdrawal of consent | 23 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Protocol violation | 9 |
| Withdrew: Miscellaneous | 3 |
Safety is monitored by collecting AEs, which include abnormal lab parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A serious AE (SAE) was an AE resulting in death, persistent or significant disability/incapacity or congenital anomaly/birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity (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. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after the intake of first dose of double-blind study drug (if on FDC in 905-CL-055) or after first open-label dose until 30 days after the last dose of open-label study drug (in 905-CL-057).
| participants | Total Group |
|---|---|
| Participants With Treatment-Emergent Adverse Event | 499 |
| Drug-related AEs | 255 |
| Drug-related SAEs | 12 |
| Any TEAE causing discontinuation of study drug. | 69 |
PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.
| ml | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume | 10.7 ± 49.28 |
Qmax during a micturition (urination) was recorded using uroflowmetry.
| ml/s | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) | 4.54 ± 5.927 |
Qmean during a micturition (urination) was recorded using uroflowmetry.
| ml/s | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Average Flow Rate (Qmean) | 2.05 ± 2.884 |
The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: • Incomplete emptying of the bladder • Intermittency • Weak stream • Hesitancy • Frequency • Urgency • Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic).
| units on a scale | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS) | -9.0 ± 5.69 |
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.
| micturitions | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | -2.5 ± 2.37 |
A micturition is any voluntary urination, excluding episodes of incontinence only. 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.
| ml | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition | 39.0 ± 47.32 |
A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
| ml | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition | 16.6 ± 101.24 |
An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
| urgency episodes | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours | -3.1 ± 3.45 |
An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
| urgency incontinence episodes | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours | -1.5 ± 2.02 |
An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
| incontinence episodes | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | -1.4 ± 2.09 |
A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
| nocturia episodes | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours | -0.7 ± 1.05 |
The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
| pads | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours | -0.9 ± 1.48 |
The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale: • 0. No urgency; • 1. Mild urgency; • 2. Moderate urgency; • 3. Severe urgency; • 4. Urgency incontinence TUS/TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency.
| units on a scale | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS]) | -10.1 ± 9.23 |
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. 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 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).
| units on a scale | Total Group |
|---|---|
| Change From Baseline to End of Treatment in IPSS Voiding Score | -4.7 ± 4.09 |
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on 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 storage questions (frequency,urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).
| units on a scale | Total Group |
|---|---|
| Change From Baseline to End of Treatment in IPSS Storage Score | -4.3 ± 2.88 |
The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).
| units on a scale | Total Group |
|---|---|
| Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score | -1.9 ± 1.53 |
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: • Incomplete emptying of the bladder • Intermittency • Weak stream • Hesitancy • Frequency • Urgency • Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom.
| units on a scale | Total Group |
|---|---|
| Incomplete emptying of the bladder | -1.3 ± 1.49 |
| Frequency | -1.7 ± 1.41 |
| Intermittency | -1.0 ± 1.48 |
| Urgency | -1.8 ± 1.54 |
| Weak stream | -1.6 ± 1.62 |
| Hesitancy | -0.8 ± 1.42 |
| Nocturia | -0.9 ± 1.17 |
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6.The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement.
| units on a scale | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Symptom Bother Score | -20.6 ± 17.45 |
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
| units on a scale | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score | 17.3 ± 18.98 |
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
| units on a scale | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score | 15.0 ± 18.15 |
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
| units on a scale | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score | 15.3 ± 19.61 |
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
| units on a scale | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score | 7.6 ± 15.15 |
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
| units on a scale | Total Group |
|---|---|
| Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score | 14.3 ± 15.59 |
A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.
| percentage of participants | Total Group |
|---|---|
| Number of OAB-q Responders Based on Health-related Quality of Life: Total Score | 55.7 |
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed).
| participants | Total Group |
|---|---|
| No problem -> No problem | 775 |
| No problem -> Some problem | 58 |
| No problem -> confined to bed | 1 |
| No problem -> no data | 0 |
| Some problem -> No problem | 67 |
| Some problem -> Some problem | 102 |
| Some problem -> confined to bed | 0 |
| Some problem -> No data | 0 |
| Confined to bed -> no problem | 0 |
| Confined to bed -> some problem | 0 |
| Confined to bed -> confined to bed | 0 |
| Confined to bed -> no data | 0 |
| No data -> no problem | 1 |
| No data -> some problem | 0 |
| No data -> confined to bed | 0 |
| No data -> no data | 0 |
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress).
| participants | Total Group |
|---|---|
| No problem -> No problem | 934 |
| No problem -> Some problem | 27 |
| No problem -> Unable to wash/dress | 1 |
| No problem -> No data | 0 |
| Some problem -> no problem | 18 |
| Some problem -> some problem | 19 |
| Some problem -> unable to wash/dress | 0 |
| Some problem -> no data | 0 |
| Unable to wash/dress -> no problem | 2 |
| Unable to wash/dress -> some problem | 0 |
| Unable to wash/dress -> unable to wash/dress | 0 |
| Unable to wash/dress -> no data | 0 |
| No data -> no problem | 3 |
| No data -> some problem | 0 |
| No data -> unable to wash/dress | 0 |
| No data -> no data | 0 |
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities).
| participants | Total Group |
|---|---|
| No problem -> No problem | 805 |
| No problem -> Some problem | 54 |
| No problem -> unable to perform usual activities | 1 |
| No problem -> no data | 0 |
| Some problem -> no problem | 80 |
| Some problem -> some problem | 60 |
| Some problem -> unable to perform usual activities | 0 |
| Some problem -> no data | 0 |
| Unable to perform usual activities -> no problem | 1 |
| Unable to perform usual activities -> some problem | 2 |
| Unable to perform usual activities -> same status | 0 |
| Unable to perform usual activities -> no data | 0 |
| No data -> no problem | 1 |
| No data -> some problem | 0 |
| No data -> unable to perform usual activities | 0 |
| No data -> no data | 0 |
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain).
| participants | Total Group |
|---|---|
| No pain -> no pain | 499 |
| No pain -> moderate pain | 71 |
| No pain -> extreme pain | 2 |
| No pain -> no data | 0 |
| Moderate pain -> no pain | 202 |
| Moderate pain -> moderate pain | 200 |
| Moderate pain -> extreme pain | 5 |
| Moderate pain -> no data | 0 |
| Extreme pain -> no pain | 10 |
| Extreme pain -> moderate pain | 7 |
| Extreme pain -> extreme pain | 6 |
| Extreme pain -> no data | 0 |
| No data -> no pain | 2 |
| No data -> moderate pain | 0 |
| No data -> extreme pain | 0 |
| No data -> no data | 0 |
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious).
| participants | Total Group |
|---|---|
| Not anxious -> Not anxious | 737 |
| Not anxious -> moderately anxious | 37 |
| Not anxious -> extremely anxious | 1 |
| Not anxious -> no data | 0 |
| Moderately anxious -> not anxious | 103 |
| Moderately anxious -> moderately anxious | 109 |
| Moderately anxious -> extremely anxious | 3 |
| Moderately anxious -> no data | 0 |
| Extremely anxious -> not anxious | 4 |
| Extremely anxious -> moderately anxious | 4 |
| Extremely anxious -> extremely anxious | 5 |
| Extremely anxious -> no data | 0 |
| No data -> not anxious | 1 |
| No data -> moderately anxious | 0 |
| No data -> extremely anxious | 0 |
| No data -> no data | 0 |
Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).
| units on a scale | Total Group |
|---|---|
| Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score | 6.4 ± 17.15 |
Collected over From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total Group | — | 64/1,066 (6%) | 180/1,066 (16.9%) |
| Event | Total Group |
|---|---|
| Urinary retentionRenal and urinary disorders | 6/1066 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 3/1066 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/1066 |
| Bladder cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/1066 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/1066 |
| Angina pectorisCardiac disorders | 2/1066 |
| Atrial fibillationCardiac disorders | 2/1066 |
| Myocardial infarctionCardiac disorders | 2/1066 |
| Transient ischaemic attackNervous system disorders | 2/1066 |
| Renal failure acuteRenal and urinary disorders | 2/1066 |
| Event | Total Group |
|---|---|
| Dry MouthGastrointestinal disorders | 132/1066 |
| ConstipationGastrointestinal disorders | 55/1066 |
SAF and FAS (study-specific)
| Age, Customized(participants) | Total Group |
|---|---|
| <65 years | 540 |
| >65 and < 75 years | 417 |
| > 75 years | 109 |
| Sex/Gender, Customized(participants) | Total Group |
|---|---|
| Male | 1066 |
| Female | 0 |
| Race/Ethnicity, Customized(participants) | Total Group |
|---|---|
| White | 1060 |
| Black | 3 |
| Asian | 2 |
| Other | 1 |
| Total International Prostate Symptom Score (IPSS)(units on a scale) | Total Group |
|---|---|
| Mean | 18.7 ± 4.41 |
| Total International Prostate Symptom Score (IPSS) voiding score(units on a scale) | Total Group |
|---|---|
| Mean | 9.8 ± 3.58 |
| Total International Prostate Symptom Score (IPSS) storage score(units on a scale) | Total Group |
|---|---|
| Mean | 8.9 ± 2.37 |
| IPSS Quality of Life Score(Qol) score(units on a scale) | Total Group |
|---|---|
| Mean | 4.1 ± 1.09 |
| Total Urgency Frequency Score (TUFS) (previous known as Total Urgency Score (TUS)(units on a scale) | Total Group |
|---|---|
| Mean | 27.18 ± 8.59 |
5 further baseline measures are reported on the registry.
Plan to share: Yes — Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Data sharing details ↗ · www.clinicaltrials.astellas.com
Ran from Apr 2010 to primary completion in Dec 2011, 19 months.
Results were first posted in Jan 2016, 4 years 1 month after primary completion.
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Studies of the drugs tested here: Tamsulosin · Solifenacin
Lower Urinary Tract Symptoms →