Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Conditions
Keywords
Vesomni, Solifenacin succinate, EC905, Tamsulosin hydrochloride OCAS, Treatment, Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
Brief summary
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.
Detailed description
This is an open-label extension study following the double blind 905-CL-055 study
Interventions
Sponsors
Astellas Pharma Europe B.V.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Completion of 12 weeks double-blind treatment in Study 905-CL-055
Exclusion criteria
* Any significant PVR volume (\>150 mL)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 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) | 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). |
| Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume | Baseline and up to 52 weeks of FDC treatment | PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan. |
| Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) | Baseline and up to 52 weeks of FDC treatment | Qmax during a micturition (urination) was recorded using uroflowmetry. |
| Change From Baseline to End of Treatment in Average Flow Rate (Qmean) | Baseline and up to 52 weeks of FDC treatment | Qmean during a micturition (urination) was recorded using uroflowmetry. |
| Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS) | Baseline and up to 52 weeks of FDC treatment | 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). |
| Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS]) | Baseline and up to 52 weeks of FDC treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours | Baseline and up to 52 weeks of FDC treatment | 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. |
| Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours | Baseline and up to 52 weeks of FDC treatment | 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. |
| Change From Baseline to End of Treatment in IPSS Voiding Score | Baseline and up to 52 weeks of FDC treatment | 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). |
| Change From Baseline to End of Treatment in IPSS Storage Score | Baseline and up to 52 weeks of FDC treatment | 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). |
| Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score | Baseline and up to 52 weeks of FDC treatment | 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). |
| Change From Baseline to End of Treatment in Individual IPSS Scores | Baseline and up to 52 weeks of FDC treatment | 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. |
| Change From Baseline to End of Treatment in Symptom Bother Score | Baseline and up to 52 weeks of FDC treatment | 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. |
| Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score | Baseline and up to 52 weeks of FDC treatment | 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. |
| Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score | Baseline and up to 52 weeks of FDC treatment | 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. |
| Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | Baseline and up to 52 weeks of FDC treatment | 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. |
| Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score | Baseline and up to 52 weeks of FDC treatment | 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. |
| Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score | Baseline and up to 52 weeks of FDC treatment | 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. |
| Number of OAB-q Responders Based on Health-related Quality of Life: Total Score | Baseline and up to 52 weeks of FDC treatment | A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10. |
| Change From Baseline to End of Treatment in EQ-5D Mobility Score | Baseline and up to 52 weeks of FDC treatment | 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). |
| Change From Baseline to End of Treatment in EQ-5D Self-care Score | Baseline and up to 52 weeks of FDC treatment | 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). |
| Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | Baseline and up to 52 weeks of FDC treatment | 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). |
| Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | Baseline and up to 52 weeks of FDC treatment | 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). |
| Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | Baseline and up to 52 weeks of FDC treatment | 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). |
| Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score | Baseline and up to 52 weeks of FDC treatment | 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). |
| Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score | Baseline and up to 52 weeks of FDC treatment | 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. |
| Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition | Baseline and up to 52 weeks of FDC treatment | 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. |
| Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition | Baseline and up to 52 weeks of FDC treatment | 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. |
| Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours | Baseline and up to 52 weeks of FDC treatment | 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. |
| Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Baseline and up to 52 weeks of FDC treatment | 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. |
| Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and up to 52 weeks of FDC treatment | 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. |
Countries
Austria, Belarus, Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Slovakia, United Kingdom
Participant flow
Recruitment details
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.
Pre-assignment details
All eligible participants started with 4 weeks of open-label FDC 0.4 mg/6 mg and were given the opportunity to adjust their dose at 3 monthly intervals thereafter if desired.
Participants by arm
| Arm | Count |
|---|---|
| Total Group Participants who received at least one dose of open-label FDC treatment | 1,066 |
| Total | 1,066 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 43 |
| Overall Study | Lack of Efficacy | 19 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Miscellaneous | 3 |
| Overall Study | Not fulfilling incl./excl.criteria | 5 |
| Overall Study | Protocol Violation | 9 |
| Overall Study | Withdrawal of Consent | 23 |
Baseline characteristics
| Characteristic | Total Group |
|---|---|
| Age, Customized >65 and < 75 years | 417 participants |
| Age, Customized <65 years | 540 participants |
| Age, Customized > 75 years | 109 participants |
| Incontinence episodes/24 hour | 1.77 incontinence episodes STANDARD_DEVIATION 2.04 |
| IPSS Quality of Life Score(Qol) score | 4.1 units on a scale STANDARD_DEVIATION 1.09 |
| Micturitions/24 hour | 11.44 micturitions STANDARD_DEVIATION 2.61 |
| Nocturia episodes/ 24 hour | 2.40 nocturia episodes STANDARD_DEVIATION 1.26 |
| Race/Ethnicity, Customized Asian | 2 participants |
| Race/Ethnicity, Customized Black | 3 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Race/Ethnicity, Customized White | 1060 participants |
| Sex/Gender, Customized Female | 0 participants |
| Sex/Gender, Customized Male | 1066 participants |
| Total International Prostate Symptom Score (IPSS) | 18.7 units on a scale STANDARD_DEVIATION 4.41 |
| Total International Prostate Symptom Score (IPSS) storage score | 8.9 units on a scale STANDARD_DEVIATION 2.37 |
| Total International Prostate Symptom Score (IPSS) voiding score | 9.8 units on a scale STANDARD_DEVIATION 3.58 |
| Total Urgency Frequency Score (TUFS) (previous known as Total Urgency Score (TUS) | 27.18 units on a scale STANDARD_DEVIATION 8.59 |
| Urgency incontinence episodes /24 hour | 1.74 urgency incontinence episodes STANDARD_DEVIATION 1.97 |
| Volume voided/micturition | 162.81 ml STANDARD_DEVIATION 47.57 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 180 / 1,066 |
| serious Total, serious adverse events | 64 / 1,066 |
Outcome results
Primary
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
Population: SAF population with at least one baseline and one post-baseline micturition episode.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Average Flow Rate (Qmean) | 2.05 ml/s | Standard Deviation 2.884 |
Primary
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
Population: SAF population with at least one baseine and one post-baseline micturition episode.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) | 4.54 ml/s | Standard Deviation 5.927 |
Primary
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
Population: SAF population with at least one baseline and one post-baseline PVR volume measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume | 10.7 ml | Standard Deviation 49.28 |
Primary
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
Population: Full Analysis Set (FAS)-participants who took at least 1 dose of the FDC during the open-label study, had a total IPSS or TUS at baseline and had at least one total IPSS or TUS after first dose of the FDC in Study 905-CL-057. Excluded 5 participants with invalid questionnaires. Last Observation Carried Forward (LOCF) imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS) | -9.0 units on a scale | Standard Deviation 5.69 |
Primary
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
Population: FAS population with data available at both baseline and end of treatment. LOCF imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS]) | -10.1 units on a scale | Standard Deviation 9.23 |
Primary
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)
Population: Safety analysis set-participants who received at least 1 dose of the FDC tamsulosin/solifenacin 0.4 mg/6 mg or 0.4 mg/9 mg during the open-label treatment period and had any data reported after the first dose of the FDC during the open-label treatment period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Group | Number of Participants With Adverse Events (AEs) | Participants With Treatment-Emergent Adverse Event | 499 participants |
| Total Group | Number of Participants With Adverse Events (AEs) | Drug-related AEs | 255 participants |
| Total Group | Number of Participants With Adverse Events (AEs) | Drug-related SAEs | 12 participants |
| Total Group | Number of Participants With Adverse Events (AEs) | Any TEAE causing discontinuation of study drug. | 69 participants |
Secondary
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
Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | Not anxious -> Not anxious | 737 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | Not anxious -> moderately anxious | 37 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | Not anxious -> extremely anxious | 1 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | Not anxious -> no data | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | Moderately anxious -> not anxious | 103 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | Moderately anxious -> moderately anxious | 109 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | Moderately anxious -> extremely anxious | 3 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | Moderately anxious -> no data | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | Extremely anxious -> not anxious | 4 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | Extremely anxious -> moderately anxious | 4 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | Extremely anxious -> extremely anxious | 5 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | Extremely anxious -> no data | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | No data -> not anxious | 1 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | No data -> moderately anxious | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | No data -> extremely anxious | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score | No data -> no data | 0 participants |
Secondary
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
Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in EQ-5D Mobility Score | No problem -> No problem | 775 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Mobility Score | No problem -> Some problem | 58 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Mobility Score | No problem -> confined to bed | 1 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Mobility Score | No problem -> no data | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Mobility Score | Some problem -> No problem | 67 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Mobility Score | Some problem -> Some problem | 102 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Mobility Score | Some problem -> confined to bed | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Mobility Score | Some problem -> No data | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Mobility Score | Confined to bed -> no problem | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Mobility Score | Confined to bed -> some problem | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Mobility Score | Confined to bed -> confined to bed | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Mobility Score | Confined to bed -> no data | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Mobility Score | No data -> no problem | 1 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Mobility Score | No data -> some problem | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Mobility Score | No data -> confined to bed | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Mobility Score | No data -> no data | 0 participants |
Secondary
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
Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | No pain -> no pain | 499 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | No pain -> moderate pain | 71 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | No pain -> extreme pain | 2 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | No pain -> no data | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | Moderate pain -> no pain | 202 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | Moderate pain -> moderate pain | 200 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | Moderate pain -> extreme pain | 5 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | Moderate pain -> no data | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | Extreme pain -> no pain | 10 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | Extreme pain -> moderate pain | 7 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | Extreme pain -> extreme pain | 6 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | Extreme pain -> no data | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | No data -> no pain | 2 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | No data -> moderate pain | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | No data -> extreme pain | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score | No data -> no data | 0 participants |
Secondary
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
Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in EQ-5D Self-care Score | No problem -> No problem | 934 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Self-care Score | No problem -> Some problem | 27 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Self-care Score | No problem -> Unable to wash/dress | 1 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Self-care Score | No problem -> No data | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Self-care Score | Some problem -> no problem | 18 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Self-care Score | Some problem -> some problem | 19 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Self-care Score | Some problem -> unable to wash/dress | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Self-care Score | Some problem -> no data | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Self-care Score | Unable to wash/dress -> no problem | 2 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Self-care Score | Unable to wash/dress -> some problem | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Self-care Score | Unable to wash/dress -> unable to wash/dress | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Self-care Score | Unable to wash/dress -> no data | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Self-care Score | No data -> no problem | 3 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Self-care Score | No data -> some problem | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Self-care Score | No data -> unable to wash/dress | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Self-care Score | No data -> no data | 0 participants |
Secondary
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
Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | No problem -> No problem | 805 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | No problem -> Some problem | 54 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | No problem -> unable to perform usual activities | 1 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | No problem -> no data | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | Some problem -> no problem | 80 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | Some problem -> some problem | 60 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | Some problem -> unable to perform usual activities | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | Some problem -> no data | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | Unable to perform usual activities -> no problem | 1 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | Unable to perform usual activities -> some problem | 2 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | Unable to perform usual activities -> same status | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | Unable to perform usual activities -> no data | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | No data -> no problem | 1 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | No data -> some problem | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | No data -> unable to perform usual activities | 0 participants |
| Total Group | Change From Baseline to End of Treatment in EQ-5D Usual Activities Score | No data -> no data | 0 participants |
Secondary
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
Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score | 6.4 units on a scale | Standard Deviation 17.15 |
Secondary
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
Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score | 15.0 units on a scale | Standard Deviation 18.15 |
Secondary
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
Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score | 17.3 units on a scale | Standard Deviation 18.98 |
Secondary
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
Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score | 15.3 units on a scale | Standard Deviation 19.61 |
Secondary
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
Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score | 7.6 units on a scale | Standard Deviation 15.15 |
Secondary
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
Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score | 14.3 units on a scale | Standard Deviation 15.59 |
Secondary
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
Population: A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Individual IPSS Scores | Incomplete emptying of the bladder | -1.3 units on a scale | Standard Deviation 1.49 |
| Total Group | Change From Baseline to End of Treatment in Individual IPSS Scores | Frequency | -1.7 units on a scale | Standard Deviation 1.41 |
| Total Group | Change From Baseline to End of Treatment in Individual IPSS Scores | Intermittency | -1.0 units on a scale | Standard Deviation 1.48 |
| Total Group | Change From Baseline to End of Treatment in Individual IPSS Scores | Urgency | -1.8 units on a scale | Standard Deviation 1.54 |
| Total Group | Change From Baseline to End of Treatment in Individual IPSS Scores | Weak stream | -1.6 units on a scale | Standard Deviation 1.62 |
| Total Group | Change From Baseline to End of Treatment in Individual IPSS Scores | Hesitancy | -0.8 units on a scale | Standard Deviation 1.42 |
| Total Group | Change From Baseline to End of Treatment in Individual IPSS Scores | Nocturia | -0.9 units on a scale | Standard Deviation 1.17 |
Secondary
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
Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score | -1.9 units on a scale | Standard Deviation 1.53 |
Secondary
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
Population: A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in IPSS Storage Score | -4.3 units on a scale | Standard Deviation 2.88 |
Secondary
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
Population: A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in IPSS Voiding Score | -4.7 units on a scale | Standard Deviation 4.09 |
Secondary
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
Population: FAS population with data available at both baseline and end of treatment. LOCF imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition | 16.6 ml | Standard Deviation 101.24 |
Secondary
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
Population: FAS population and at least 1 incontinence episode at baseline. LOCF imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | -1.4 incontinence episodes | Standard Deviation 2.09 |
Secondary
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
Population: FAS population with data available at both baseline and end of treatment. LOCF imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | -2.5 micturitions | Standard Deviation 2.37 |
Secondary
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
Population: FAS population and at least 1 nocturia episode at baseline. LOCF imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours | -0.7 nocturia episodes | Standard Deviation 1.05 |
Secondary
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
Population: FAS population and at least 1 use of a pad at baseline. LOCF imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours | -0.9 pads | Standard Deviation 1.48 |
Secondary
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
Population: FAS population with at least 1 urgency episode at baseline. LOCF imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 urgency episodes | Standard Deviation 3.45 |
Secondary
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
Population: FAS population and at least 1 urgency incontinence episode at baseline. LOCF imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours | -1.5 urgency incontinence episodes | Standard Deviation 2.02 |
Secondary
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
Population: FAS population with data available at both baseline and end of treatment. LOCF imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition | 39.0 ml | Standard Deviation 47.32 |
Secondary
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
Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Change From Baseline to End of Treatment in Symptom Bother Score | -20.6 units on a scale | Standard Deviation 17.45 |
Secondary
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
Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Group | Number of OAB-q Responders Based on Health-related Quality of Life: Total Score | 55.7 percentage of participants |