A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder
- Conditions
- Overactive BladderUrinary Bladder OveractiveUrgency IncontinenceUrinary Bladder Diseases\Urologic Diseases
- Interventions
- Registration Number
- NCT02045862
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Brief Summary
The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1829
Main Inclusion at Screening (Visit 1):
- Subject had completed study 178-CL-101 or study 905-EC-012 (This inclusion criterion would no longer apply once the recruitment for study 178-CL-101 and study 905-EC-012 had been completed. In that case the subject had to have symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months);
- Subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
Main Inclusion at Randomization (Visit 2):
- Subject had a micturition frequency of on average ≥ 8 times per 24-hour period during the last 7 days of the micturition diary period (incontinence episode should not be counted as a micturition).
- Subject had experienced at least 3 incontinence episodes during the last 7 days of the micturition diary period.
- Subject had experienced on average at least 1 urgency episode (grade 3 or 4 on Patient Perception of Intensity of Urgency Scale [PPIUS]) per 24-hour period during the 7-day micturition diary period.
Main Exclusion at Screening (Visit 1):
- Subject had clinically significant bladder outflow obstruction at risk of urinary retention;
- Subject had significant PVR volume (> 150 mL);
- Subject had significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor;
- Subject has an indwelling catheter or practices intermittent self-catheterization;
- Subject had evidence of a UTI (urine culture containing > 100,000 cfu/mL), chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs;
- Subject had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin;
Main Exclusion at Randomization (Visit 2):
- Subject had evidence of a urinary tract infection (UTI) (urine culture containing > 100,000 cfu/mL) as assessed in the Screening visit (V1) samples. The subject could be rescreened after successful treatment of the UTI (confirmed by a dipstick negative for nitrite).
- Subject had an average total daily urine volume > 3000 mL as recorded in the micturition diary period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mirabegron 50 mg Placebo to match solifenacin Participants received mirabegron 50 mg once a day for 52 weeks. Solifenacin 5 mg Placebo to match mirabegron Participants received solifenacin 5 mg once a day for 52 weeks. Mirabegron 50 mg Mirabegron Participants received mirabegron 50 mg once a day for 52 weeks. Solifenacin 5 mg Solifenacin succinate Participants received solifenacin 5 mg once a day for 52 weeks. Solifenacin 5 mg + Mirabegron 50 mg Solifenacin succinate Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks. Solifenacin 5 mg + Mirabegron 50 mg Mirabegron Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours Baseline and Week 52 An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and week 52 clinic visits.
Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours Baseline and Week 52 A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and week 52 clinic visits.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks) A TEAE was defined as an adverse event (AE) observed after taking the first dose of double-blind treatment until 14 days after taking the last dose of double-blind treatment for non-serious AEs and until 30 days after taking the last dose of double-blind treatment for serious adverse events (SAEs). This included abnormal laboratory tests, vital signs or electrocardiogram data that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The severity of each AE was defined according to the following: Mild (No disruption of normal daily activities); Moderate (Affected normal daily activities) and Severe (Inability to perform daily activities).
- Secondary Outcome Measures
Name Time Method Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern Baseline and Months 1, 3, 6, 9, 12 The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to EoT in Corrected Micturition Frequency Baseline and Month 12 Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline. Corrected micturition frequency was calculated as the baseline mean volume voided per micturition multiplied by the baseline mean number of micturitions per 24 hours divided by the mean volume voided per micturition at EoT.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping Baseline and Months 1, 3, 6, 9, 12 The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Months 1, 3, 6, 9, 12 An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours Baseline and Months 1, 3, 6, 9, 12 A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and prior to each visit.
Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT) Months 1, 3, 6, 9, 12 The number of days with \< 8 micturitions was the number of valid diary days during the 7-day micturition diary period with with less than 8 micturitions per day.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours Baseline and Months 1, 3, 6, 9, 12 The mean number of pads used per 24 hours was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit.
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities Baseline and Month 12 The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression Baseline and Month 12 The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and had 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed Baseline and Months 6,12 The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Baseline and Months 1, 3, 6, 9, 12 An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Baseline and Months 1, 3, 6, 9, 12 An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort Baseline and Month 12 The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and had 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours Baseline and Months 1, 3, 6, 9, 12 An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.
Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit Months 1, 3, 6, 9, 12 A nocturia episode was defined as waking at night 1 or more times 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 participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score Baseline and Months 1, 3, 6, 9, 12 The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was 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 indicated an improvement.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social Baseline and Months 1, 3, 6, 9, 12 The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Baseline and Months 1, 3, 6, 9, 12 A nocturia episode was defined as waking at night 1 or more times 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 participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit
Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score Baseline and Months 1, 3, 6, 9, 12 The 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 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep Baseline and Months 1, 3, 6, 9, 12 The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consisted of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each time was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC) Baseline and Months 1, 3, 6, 9, 12 The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT Month 12 The PGIC is a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
Change From Baseline to EoT in Mean Volume Voided Per Micturition Baseline and Week 52 The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period.
Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS) Baseline and Week 52 The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours Baseline and Months 1, 3, 6, 9, 12 An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and prior to each visit.
Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score Baseline and Week 52 The 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 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit Months 1, 3, 6, 9, 12 The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period prior to each visit with no incontinence episodes recorded.
Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit Months 1, 3, 6, 9, 12 The number of incontinence-free days with \< 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with \< 8 micturitions per day.
Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit Months 1, 3, 6, 9, 12 An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceeded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.
Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition Baseline and Months 3, 6, 12 The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period prior to each visit.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours Baseline and Months 1, 3, 6, 9, 12 Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode recorded by the participant in the micturition diary for 7 days prior to each visit as 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours Baseline and Months 1, 3, 6, 9, 12 A nocturia episode was defined as waking at night 1 or more times 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 participant gets up in the morning with the intention to stay awake). The mean number of nocturia episodes was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit."
Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit Months 1, 3, 6, 9, 12 The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit Baseline and Months 1, 3, 6, 9, 12 The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.
Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS Baseline and Months 1, 3, 6, 9, 12 The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT Month 12 The PGIC is a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility Baseline and 12 Months The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care Baseline and Month 12 The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working Baseline and Months 6, 12 The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT Months 1, 3, 6, 9, 12 An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the last 3 days of the 7-day micturition diary is reported.
Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT Baseline and Months 1, 3, 6, 9, 12 The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT Baseline and Months 1, 3, 6, 9, 12 An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT Baseline and Months 1, 3, 6, 9, 12 The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The HRQoL portion of the OAB-q consists of 25 HRQoL items comprising 4 HRQoL subscales, each item was scored 1-6. The total score was 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 indicated an improvement.The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment Baseline and Months 6, 12 The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes arre expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment Baseline and Months 6, 12 The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume Baseline and Months 1, 3, 6, 9, 12 PVR volume was assessed by ultrasonography or a bladder scanner.
Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT Baseline and Months 1, 3, 6, 9, 12 The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT Baseline and Months 1, 3, 6, 9, 12 The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was 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 indicated an improvement.
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT Baseline and Months 1, 3, 6, 9, 12 An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.
Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT Baseline and Months 1, 3, 6, 9, 12 The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Months 1, 3, 6, 9, 12 and EoT Baseline and Months 1, 3, 6, 9, 12 An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Months 1, 3, 6, 9, 12 and EoT Baseline and Months 1, 3, 6, 9, 12 An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was 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 indicated an improvement.
Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT Baseline and Months 1, 3, 6, 9, 12 The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The symptom bother portion of the OAB-q consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT Months 1, 3, 6, 9, 12 An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the 7-day micturition diary is reported.
Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT Baseline and Months 1, 3, 6, 9, 12 The percentage of participants with micturition frequency normalization was defined as participants who had ≥ 8 micturitions/24 hours at baseline and \< 8 micturitions/24 hours postbaseline at months 1, 3, 6, 9, 12 and EoT.
Trial Locations
- Locations (251)
Site US10133
🇺🇸Los Angeles, California, United States
Site US10553
🇺🇸Lincoln, Nebraska, United States
Site US10148
🇺🇸Hialeah, Florida, United States
Site US10153
🇺🇸Hialeah, Florida, United States
Site US10154
🇺🇸Missoula, Montana, United States
Site CA15008
🇨🇦Saint John, New Brunswick, Canada
Site US10009
🇺🇸Pembroke Pines, Florida, United States
Site US10250
🇺🇸Pittsburgh, Pennsylvania, United States
Site US10248
🇺🇸Pittsburgh, Pennsylvania, United States
Site US10093
🇺🇸Houston, Texas, United States
Site CA15039
🇨🇦Levis, Quebec, Canada
Site RU70018
🇷🇺Ufa, Russian Federation
Site US10112
🇺🇸Mobile, Alabama, United States
Site US10127
🇺🇸Roswell, Georgia, United States
Site US10132
🇺🇸Los Angeles, California, United States
Site US10050
🇺🇸Cleveland, Ohio, United States
Site US10053
🇺🇸Wheat Ridge, Colorado, United States
Site US10028
🇺🇸Poughkeepsie, New York, United States
Site US10167
🇺🇸Pittsburgh, Pennsylvania, United States
Site US10150
🇺🇸New Port Richey, Florida, United States
Site US10091
🇺🇸Jupiter, Florida, United States
Site US10049
🇺🇸Mobile, Alabama, United States
Site US10060
🇺🇸Bradenton, Florida, United States
Site US10097
🇺🇸Hialeah, Florida, United States
Site US10554
🇺🇸Plantation, Florida, United States
Site US10282
🇺🇸Boston, Massachusetts, United States
Site US10082
🇺🇸Hawaiian Gardens, California, United States
Site US10149
🇺🇸Paramount, California, United States
Site US10595
🇺🇸Valley Village, California, United States
Site US10120
🇺🇸Sandy Springs, Georgia, United States
Site US10076
🇺🇸Concord, North Carolina, United States
Site US10122
🇺🇸Anaheim, California, United States
Site US10106
🇺🇸Tarzana, California, United States
Site US10088
🇺🇸Lake Charles, Louisiana, United States
Site US10078
🇺🇸Wichita, Kansas, United States
Site US10558
🇺🇸Hanover, Maryland, United States
Site US10002
🇺🇸Englewood, New Jersey, United States
Site US10025
🇺🇸Shreveport, Louisiana, United States
Site US10040
🇺🇸Kingston, New York, United States
Site US10017
🇺🇸Philadelphia, Pennsylvania, United States
Site US10168
🇺🇸New York, New York, United States
Site US10114
🇺🇸Watertown, Massachusetts, United States
Site US10047
🇺🇸Lawrenceville, New Jersey, United States
Site US10126
🇺🇸Newburgh, New York, United States
Site US10129
🇺🇸Raleigh, North Carolina, United States
Site US10541
🇺🇸Medford, Oregon, United States
Site US10065
🇺🇸Corpus Christi, Texas, United States
Site US10101
🇺🇸Summerville, South Carolina, United States
Site AU61025
🇦🇺Footscray, Victoria, Australia
Site AU61019
🇦🇺Sherwood, Queensland, Australia
Site US10219
🇺🇸Houston, Texas, United States
Site AU61007
🇦🇺Randwick, New South Wales, Australia
Site US10006
🇺🇸Kingsport, Tennessee, United States
Site US10079
🇺🇸Mount Pleasant, South Carolina, United States
Site US10083
🇺🇸Virginia Beach, Virginia, United States
Site US10085
🇺🇸Houston, Texas, United States
Site US10023
🇺🇸Simpsonville, South Carolina, United States
Site DE49031
🇩🇪Bergisch Gladbach, Northwest, Germany
Site BE32004
🇧🇪Gent, Belgium
Site CA15006
🇨🇦Brampton, Ontario, Canada
Site US10155
🇺🇸Seattle, Washington, United States
Site US10090
🇺🇸Hurst, Texas, United States
Site AU61011
🇦🇺Wollongong, New South Wales, Australia
Site CA15001
🇨🇦Barrie, Ontario, Canada
Site US10004
🇺🇸Mountlake Terrace, Washington, United States
Site CA15025
🇨🇦Quebec, Canada
Site CZ42015
🇨🇿Brno, Czechia
Site CZ42003
🇨🇿Hradec Kralove, Czechia
Site CZ42001
🇨🇿Hradec Kralove, Czechia
Site BE32012
🇧🇪Sint-Truiden, Belgium
Site AU61015
🇦🇺Daw Park, South Australia, Australia
Site CA15004
🇨🇦Toronto, Ontario, Canada
Site DE49010
🇩🇪Ganderkesee, Germany
Site CZ42006
🇨🇿Usti nad Labem, Czechia
Site BG35908
🇧🇬Plovdiv, Bulgaria
Site CZ42014
🇨🇿Ostrava, Czechia
Site CA15003
🇨🇦Brantford, Ontario, Canada
Site DE49032
🇩🇪Duisburg, NRW, Germany
Site CA15033
🇨🇦Vancouver, British Columbia, Canada
Site CZ42010
🇨🇿Olomouc, Czechia
Site EE37201
🇪🇪Parnu, Estonia
Site CZ42009
🇨🇿Uherske Hradiste, Czechia
Site DE49003
🇩🇪Lutherstadt Eisleben, Sachsen Anhalt, Germany
Site DE49026
🇩🇪Rostock, Germany
Site HU36012
🇭🇺Veszprem, Veszprem Megye, Hungary
Site HU36013
🇭🇺Sopron, Gyor-Moson Sopron, Hungary
Site DE49001
🇩🇪Neustadt I. Sachsen, Germany
Site DE49013
🇩🇪Leipzig, Sachsen, Germany
Site HU36007
🇭🇺Kecskemet, Bacs-Kiskun Megye, Hungary
Site DE49014
🇩🇪Sangerhausen, Germany
Site KR82006
🇰🇷Busan, Korea, Republic of
Site KR82016
🇰🇷Busan, Korea, Republic of
Site LV37102
🇱🇻Liepaja, Latvia
Site KR82023
🇰🇷Incheon, Korea, Republic of
Site NZ64002
🇳🇿Nelson, New Zealand
Site KR82019
🇰🇷Daejeon, Korea, Republic of
Site NZ64003
🇳🇿Tauranga, New Zealand
Site KR82015
🇰🇷Seoul, Korea, Republic of
Site KR82001
🇰🇷Seoul, Korea, Republic of
Site KR82003
🇰🇷Seoul, Korea, Republic of
Site KR82020
🇰🇷Seoul, Korea, Republic of
Site KR82008
🇰🇷Seoul, Korea, Republic of
Site KR82014
🇰🇷Bucheon-Si, Gyunggido, Korea, Republic of
Site KR82010
🇰🇷Jeonju-si, Jeollabuk-do South Korea, Korea, Republic of
Site NZ64001
🇳🇿Christchurch, Canterbury, New Zealand
Site KR82004
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Site KR82029
🇰🇷Daegu, Korea, Republic of
Site LT37011
🇱🇹Kaunas, Lithuania
Site NZ64006
🇳🇿Whangarei, New Zealand
Site LT37003
🇱🇹Vilnius, Lithuania
Site ES34002
🇪🇸Valencia, Spain
Site RO40014
🇷🇴Cluj-Napoca, Cluj, Romania
Site RU70015
🇷🇺Kazan, Russian Federation
Site RU70022
🇷🇺Saint Petersburg, Russian Federation
Site SG65003
🇸🇬Singapore, Singapore
Site SK42106
🇸🇰Trencin, Slovakia
Site ZA27013
🇿🇦Meyerspark, Pretoria, South Africa
Site ES34004
🇪🇸Madrid, Spain
Site ES34015
🇪🇸Madrid, Spain
Site RU70023
🇷🇺Penza, Russian Federation
Site RU70002
🇷🇺Saint Petersburg, Russian Federation
Site SG65002
🇸🇬Singapore, Singapore
Site ZA27006
🇿🇦Durban, Kwa Zulu Natal, South Africa
Site SK42101
🇸🇰Kosice, Slovakia
Site SE46016
🇸🇪Stockholm, Sweden
Site SE46012
🇸🇪Stockholm, Sweden
Site SE46003
🇸🇪Stockholm, Sweden
Site ZA27001
🇿🇦Centurion, Gauteng, South Africa
Site ZA27002
🇿🇦Roodepoort, Gauteng, South Africa
Site SE46005
🇸🇪Malmo, Sweden
Site ES34009
🇪🇸Madrid, Spain
Site UA38002
🇺🇦Cherenigiv, Ukraine
Site UA38010
🇺🇦Kyiv, Ukraine
Site UA38008
🇺🇦Zaporizhzhya, Ukraine
Site GB44001
🇬🇧Sheffield, South Yorkshire, United Kingdom
Site SE46009
🇸🇪Uppsala, Sweden
Site UA38015
🇺🇦Chernivtsi, Ukraine
Site GB44006
🇬🇧Plymouth, United Kingdom
Site UA38003
🇺🇦Kyiv, Ukraine
Site GB44009
🇬🇧Watford, United Kingdom
Site IT39022
🇮🇹Ancona, Italy
Site IT39007
🇮🇹Avellino, Italy
Site IT39001
🇮🇹Latina, Italy
Site IT39020
🇮🇹Milano, Italy
Site CA15040
🇨🇦Montreal, Canada
Site KR82012
🇰🇷Seoul, Gyunggido, Korea, Republic of
Site KR82002
🇰🇷Seoul, Korea, Republic of
Site DE49011
🇩🇪Halle (Saale), Germany
Site CZ42005
🇨🇿Plzen, Czechia
Site CZ42008
🇨🇿Praha 2, Czechia
Site CZ42013
🇨🇿Sternberk, Czechia
Site US10037
🇺🇸Alpharetta, Georgia, United States
Site US10026
🇺🇸Garden City, New York, United States
Site US10067
🇺🇸Wadsworth, Ohio, United States
Site US10135
🇺🇸Walla Walla, Washington, United States
Site AU61005
🇦🇺Broadmeadow, New South Wales, Australia
Site US10013
🇺🇸Burien, Washington, United States
Site AU61022
🇦🇺Brisbane, Queensland, Australia
Site CA15013
🇨🇦Toronto, Ontario, Canada
Site CZ42007
🇨🇿Praha 4, Czechia
Site DK45013
🇩🇰Aarhus, Denmark
Site FI35801
🇫🇮Kouvola, Finland
Site DE49008
🇩🇪Bad Ems, Germany
Site DE49002
🇩🇪Duisburg, Germany
Site KR82005
🇰🇷Daegu, Korea, Republic of
Site KR82021
🇰🇷Seoul, Korea, Republic of
Site KR82030
🇰🇷Seoul, Korea, Republic of
Site KR82013
🇰🇷Seoul, Korea, Republic of
Site KR82017
🇰🇷Seoul, Korea, Republic of
Site LV37105
🇱🇻Riga, Latvia
Site LT37004
🇱🇹Kaunas, Lithuania
Site LT37007
🇱🇹Vilnius, Lithuania
Site PL48014
🇵🇱Gdynia, Poland
Site PL48013
🇵🇱Chorzow, Poland
Site PL48004
🇵🇱Lodz, Poland
Site SE46007
🇸🇪Boras, Sweden
Site NL31010
🇳🇱Sneek, Netherlands
Site NO47006
🇳🇴Hamar, Norway
Site PL48016
🇵🇱Opole, Poland
Site RO40002
🇷🇴Timisoara, Romania
Site LT37012
🇱🇹Klaipeda, Lithuania
Site BE32014
🇧🇪Roeselare, Belgium
Site BG35903
🇧🇬Sofia, Bulgaria
Site HU36001
🇭🇺Szentes, Csongrad Megye, Hungary
Site LV37103
🇱🇻Olaine, Latvia
Site NL31005
🇳🇱Nijmegen, Netherlands
Site US10104
🇺🇸Chandler, Arizona, United States
Site DE49034
🇩🇪Munich, Bavaria, Germany
Site BG35902
🇧🇬Ruse, Bulgaria
Site CA15020
🇨🇦Montreal, Quebec, Canada
Site CA15026
🇨🇦Drummondville, Quebec, Canada
Site BG35905
🇧🇬Sofia, Bulgaria
Site US10110
🇺🇸Billings, Montana, United States
Site HU36003
🇭🇺Csongrad, Csongrad Megye, Hungary
Site LT37009
🇱🇹Vilnius, Lithuania
Site NL31006
🇳🇱Enschede, NL, Netherlands
Site PL48012
🇵🇱Warsaw, Poland
Site SK42105
🇸🇰Bratislava, Slovakia
Site SK42102
🇸🇰Trencin, Slovakia
Site SI38604
🇸🇮Murska Sobota, Slovenia
Site UA38013
🇺🇦Dnepropetrovsk, Ukraine
Site UA38007
🇺🇦Kiev, Ukraine
Site CA15027
🇨🇦Sherbrooke, Quebec, Canada
Site LT37008
🇱🇹Kaunas, Lithuania
Site LT37010
🇱🇹Vilnius, Lithuania
Site MX52003
🇲🇽Mexico City, DF, Mexico
Site NL31002
🇳🇱Amsterdam, Netherlands
Site PL48005
🇵🇱Piaseczno, Poland
Site PL48001
🇵🇱Warszawa, Poland
Site PL48019
🇵🇱Wrocław, Poland
Site RO40004
🇷🇴Bucuresti, Romania
Site RO40005
🇷🇴Bucuresti, Romania
Site RU70019
🇷🇺Saint Petersburg, Russian Federation
Site RU70014
🇷🇺St. Petersburg, Russian Federation
Site SK42108
🇸🇰Poprad, Slovakia
Site TH66008
🇹🇭Bangkok, Thailand
Site HU36005
🇭🇺Pecs, Baranya Megye, Hungary
Site MY60002
🇲🇾Petaling Jaya, Malaysia
Site NO47007
🇳🇴Alesund, Norway
Site PL48018
🇵🇱Bialystok, Poland
Site PL48010
🇵🇱Lublin, Poland
Site RO40010
🇷🇴Sibiu, Romania
Site ZA27007
🇿🇦Paarl, Western Cape, South Africa
Site NO47008
🇳🇴Lierskogen, Norway
Site PL48011
🇵🇱Myslowice, Poland
Site PL48003
🇵🇱Warszawa, Poland
Site RO40001
🇷🇴Bucuresti, Romania
Site SK42107
🇸🇰Kosice, Slovakia
Site SK42103
🇸🇰Nitra, Slovakia
Site SK42104
🇸🇰Prešov, Slovakia
Site TH66009
🇹🇭Khon Kaen, Thailand
Site US10003
🇺🇸San Diego, California, United States
Site US10021
🇺🇸Phoenix, Arizona, United States
Site US10166
🇺🇸Charleston, South Carolina, United States
Site US10124
🇺🇸Orlando, Florida, United States
Site US10134
🇺🇸Orlando, Florida, United States
Site US10011
🇺🇸Albuquerque, New Mexico, United States
Site US10109
🇺🇸Oklahoma City, Oklahoma, United States
Site US10105
🇺🇸San Antonio, Texas, United States
Site US10111
🇺🇸San Antonio, Texas, United States
Site US10062
🇺🇸Winston-Salem, North Carolina, United States
Site US10015
🇺🇸Albuquerque, New Mexico, United States
Site CA15035
🇨🇦Edmonton, Alberta, Canada
Site US10012
🇺🇸West Reading, Pennsylvania, United States
Site CA15007
🇨🇦Kitchener, Ontario, Canada
Site US10063
🇺🇸Uniontown, Pennsylvania, United States
Site US10008
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Site AU61021
🇦🇺Randwick, New South Wales, Australia
Site AU61010
🇦🇺Nambour, Queensland, Australia
Site AU61002
🇦🇺Parkville, Victoria, Australia
Site AU61004
🇦🇺Perth, Western Australia, Australia