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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 (SYNERGY II)

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ClinicalTrials.gov Identifier: NCT02045862
Recruitment Status : Completed
First Posted : January 27, 2014
Results First Posted : June 6, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( 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.

Condition or disease Intervention/treatment Phase
Urinary Bladder Overactive Overactive Bladder Urgency Incontinence Urinary Bladder Diseases\Urologic Diseases Drug: Solifenacin succinate Drug: Mirabegron Drug: Placebo to match solifenacin Drug: Placebo to match mirabegron Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1829 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate With Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects With Overactive Bladder
Actual Study Start Date : March 17, 2014
Actual Primary Completion Date : September 8, 2016
Actual Study Completion Date : September 8, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mirabegron 50 mg
Participants received mirabegron 50 mg once a day for 52 weeks.
Drug: Mirabegron
Participants received mirabegron 50 mg orally once a day at the same time each day.
Other Names:
  • Myrbetriq
  • YM178
  • Betmiga
  • Betanis

Drug: Placebo to match solifenacin
Participants received placebo to match solifenacin 5 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.

Active Comparator: Solifenacin 5 mg
Participants received solifenacin 5 mg once a day for 52 weeks.
Drug: Solifenacin succinate
Participants received solifenacin 5 mg orally once a day at the same time each day.
Other Names:
  • Vesicare
  • Vesitrim
  • YM905
  • Vesikur

Drug: Placebo to match mirabegron
Participants received placebo to match mirabegron 50 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.

Experimental: Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Drug: Solifenacin succinate
Participants received solifenacin 5 mg orally once a day at the same time each day.
Other Names:
  • Vesicare
  • Vesitrim
  • YM905
  • Vesikur

Drug: Mirabegron
Participants received mirabegron 50 mg orally once a day at the same time each day.
Other Names:
  • Myrbetriq
  • YM178
  • Betmiga
  • Betanis




Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: 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).

  2. Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours [ Time Frame: 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.

  3. Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change From Baseline to EoT in Mean Volume Voided Per Micturition [ Time Frame: 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.

  2. Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score [ Time Frame: 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.

  3. Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS) [ Time Frame: 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.

  4. Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours [ Time Frame: 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.

  5. Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit [ Time Frame: 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.

  6. 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 [ Time Frame: 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.

  7. Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit [ Time Frame: 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.

  8. Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit [ Time Frame: 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.

  9. Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours [ Time Frame: 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.

  10. Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit [ Time Frame: 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.

  11. 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 [ Time Frame: 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.

  12. Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours [ Time Frame: 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.

  13. 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) [ Time Frame: 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.

  14. Change From Baseline to EoT in Corrected Micturition Frequency [ Time Frame: 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.

  15. Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition [ Time Frame: 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.

  16. 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 [ Time Frame: 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.

  17. Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours [ Time Frame: 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."

  18. Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit [ Time Frame: 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.

  19. 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 [ Time Frame: 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

  20. Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours [ Time Frame: 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.

  21. Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit [ Time Frame: 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.

  22. 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 [ Time Frame: 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.

  23. Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score [ Time Frame: 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.

  24. Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score [ Time Frame: 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.

  25. Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping [ Time Frame: 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.

  26. Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern [ Time Frame: 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.

  27. Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep [ Time Frame: 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.

  28. Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social [ Time Frame: 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.

  29. Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS [ Time Frame: 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.

  30. Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC) [ Time Frame: 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.

  31. Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT [ Time Frame: 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).

  32. Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT [ Time Frame: 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).

  33. Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility [ Time Frame: 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).

  34. Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care [ Time Frame: 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).

  35. Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities [ Time Frame: 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).

  36. Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort [ Time Frame: 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).

  37. Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression [ Time Frame: 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).

  38. 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 [ Time Frame: 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.

  39. Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working [ Time Frame: 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.

  40. Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment [ Time Frame: 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.

  41. Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment [ Time Frame: 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.

  42. 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 [ Time Frame: 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.

  43. 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 [ Time Frame: 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.

  44. Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT [ Time Frame: 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.

  45. Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT [ Time Frame: 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.

  46. 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 [ Time Frame: 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.

  47. Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT [ Time Frame: 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.

  48. Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT [ Time Frame: 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.

  49. Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT [ Time Frame: 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.

  50. 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 [ Time Frame: 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.

  51. 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 [ Time Frame: 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.

  52. 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 [ Time Frame: 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.

  53. 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 [ Time Frame: 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.

  54. 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 [ Time Frame: 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.

  55. Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume [ Time Frame: Baseline and Months 1, 3, 6, 9, 12 ]
    PVR volume was assessed by ultrasonography or a bladder scanner.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045862


  Hide Study Locations
Locations
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United States, Alabama
Site US10049
Mobile, Alabama, United States, 36608
Site US10112
Mobile, Alabama, United States, 36608
United States, Arizona
Site US10104
Chandler, Arizona, United States, 85224
Site US10021
Phoenix, Arizona, United States, 85051
United States, California
Site US10122
Anaheim, California, United States, 92801
Site US10082
Hawaiian Gardens, California, United States, 90716
Site US10132
Los Angeles, California, United States, 90017
Site US10133
Los Angeles, California, United States, 90036
Site US10149
Paramount, California, United States, 90723
Site US10003
San Diego, California, United States, 92120
Site US10106
Tarzana, California, United States, 91356
Site US10595
Valley Village, California, United States, 91607
United States, Colorado
Site US10053
Wheat Ridge, Colorado, United States, 80033
United States, Florida
Site US10060
Bradenton, Florida, United States, 34208
Site US10097
Hialeah, Florida, United States, 33012
Site US10148
Hialeah, Florida, United States, 33016
Site US10153
Hialeah, Florida, United States, 33016
Site US10091
Jupiter, Florida, United States, 33458
Site US10150
New Port Richey, Florida, United States, 34652
Site US10124
Orlando, Florida, United States, 32803
Site US10134
Orlando, Florida, United States, 32806
Site US10009
Pembroke Pines, Florida, United States, 33027
Site US10554
Plantation, Florida, United States, 33317
United States, Georgia
Site US10037
Alpharetta, Georgia, United States, 30005
Site US10127
Roswell, Georgia, United States, 30076
Site US10120
Sandy Springs, Georgia, United States, 30328
United States, Kansas
Site US10078
Wichita, Kansas, United States, 67205
United States, Louisiana
Site US10088
Lake Charles, Louisiana, United States, 70601
Site US10025
Shreveport, Louisiana, United States, 71106
United States, Maryland
Site US10558
Hanover, Maryland, United States, 21076
United States, Massachusetts
Site US10282
Boston, Massachusetts, United States, 02131
Site US10114
Watertown, Massachusetts, United States, 02472
United States, Montana
Site US10110
Billings, Montana, United States, 59102
Site US10154
Missoula, Montana, United States, 59801
United States, Nebraska
Site US10553
Lincoln, Nebraska, United States, 68510
United States, New Jersey
Site US10002
Englewood, New Jersey, United States, 07631
Site US10047
Lawrenceville, New Jersey, United States, 08648
United States, New Mexico
Site US10011
Albuquerque, New Mexico, United States, 87102
Site US10015
Albuquerque, New Mexico, United States, 87109
United States, New York
Site US10026
Garden City, New York, United States, 11530
Site US10040
Kingston, New York, United States, 12401
Site US10168
New York, New York, United States, 10065
Site US10126
Newburgh, New York, United States, 12550
Site US10028
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Site US10076
Concord, North Carolina, United States, 28025
Site US10129
Raleigh, North Carolina, United States, 27609
Site US10062
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Site US10050
Cleveland, Ohio, United States, 44122
Site US10067
Wadsworth, Ohio, United States, 44281
United States, Oklahoma
Site US10109
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Site US10541
Medford, Oregon, United States, 97504
United States, Pennsylvania
Site US10008
Bala-Cynwyd, Pennsylvania, United States, 19004
Site US10017
Philadelphia, Pennsylvania, United States, 19114
Site US10167
Pittsburgh, Pennsylvania, United States, 15213
Site US10250
Pittsburgh, Pennsylvania, United States, 15236
Site US10248
Pittsburgh, Pennsylvania, United States, 15243
Site US10063
Uniontown, Pennsylvania, United States, 15401
Site US10012
West Reading, Pennsylvania, United States, 19611
United States, South Carolina
Site US10166
Charleston, South Carolina, United States, 29425
Site US10079
Mount Pleasant, South Carolina, United States, 29464
Site US10023
Simpsonville, South Carolina, United States, 29681
Site US10101
Summerville, South Carolina, United States, 29485
United States, Tennessee
Site US10006
Kingsport, Tennessee, United States, 37660
United States, Texas
Site US10065
Corpus Christi, Texas, United States, 78414
Site US10085
Houston, Texas, United States, 77058
Site US10219
Houston, Texas, United States, 77094
Site US10093
Houston, Texas, United States, 77099
Site US10090
Hurst, Texas, United States, 76054
Site US10105
San Antonio, Texas, United States, 78229
Site US10111
San Antonio, Texas, United States, 78229
United States, Virginia
Site US10083
Virginia Beach, Virginia, United States, 23462
United States, Washington
Site US10013
Burien, Washington, United States, 98166
Site US10004
Mountlake Terrace, Washington, United States, 98043
Site US10155
Seattle, Washington, United States, 98105
Site US10135
Walla Walla, Washington, United States, 99362
Australia, New South Wales
Site AU61005
Broadmeadow, New South Wales, Australia, 2292
Site AU61007
Randwick, New South Wales, Australia, 2031
Site AU61021
Randwick, New South Wales, Australia, 2031
Site AU61011
Wollongong, New South Wales, Australia, 2522
Australia, Queensland
Site AU61022
Brisbane, Queensland, Australia, 4152
Site AU61010
Nambour, Queensland, Australia, 4560
Site AU61019
Sherwood, Queensland, Australia, 4075
Australia, South Australia
Site AU61015
Daw Park, South Australia, Australia, 5041
Australia, Victoria
Site AU61025
Footscray, Victoria, Australia, 3011
Site AU61002
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Site AU61004
Perth, Western Australia, Australia, 6009
Belgium
Site BE32004
Gent, Belgium, 9000
Site BE32014
Roeselare, Belgium, 8800
Site BE32012
Sint-Truiden, Belgium, 3800
Bulgaria
Site BG35908
Plovdiv, Bulgaria, 4003
Site BG35902
Ruse, Bulgaria, 7000
Site BG35905
Sofia, Bulgaria, 1431
Site BG35903
Sofia, Bulgaria, 1606
Canada, Alberta
Site CA15035
Edmonton, Alberta, Canada, T5G 0B7
Canada, British Columbia
Site CA15033
Vancouver, British Columbia, Canada, V5Z 4E1
Canada, New Brunswick
Site CA15008
Saint John, New Brunswick, Canada, E2L 3J8
Canada, Ontario
Site CA15001
Barrie, Ontario, Canada, L4M 7G1
Site CA15006
Brampton, Ontario, Canada, L6T 4S5
Site CA15003
Brantford, Ontario, Canada, N3S 6T6
Site CA15007
Kitchener, Ontario, Canada, N2N 2B9
Site CA15013
Toronto, Ontario, Canada, M4N 3M5
Site CA15004
Toronto, Ontario, Canada, M4S 1Y2
Canada, Quebec
Site CA15026
Drummondville, Quebec, Canada, J2B 7T1
Site CA15039
Levis, Quebec, Canada, G6W 5M6
Site CA15020
Montreal, Quebec, Canada, H4N 3C5
Site CA15027
Sherbrooke, Quebec, Canada, J1H 1Z1
Canada
Site CA15040
Montreal, Canada, H2R 1V6
Site CA15025
Quebec, Canada, G1S 2L6
Czechia
Site CZ42015
Brno, Czechia, 602 00
Site CZ42003
Hradec Kralove, Czechia, 500 02
Site CZ42001
Hradec Kralove, Czechia, 50005
Site CZ42010
Olomouc, Czechia, 772 00
Site CZ42014
Ostrava, Czechia, 700 30
Site CZ42005
Plzen, Czechia, 32600
Site CZ42008
Praha 2, Czechia, 12808
Site CZ42007
Praha 4, Czechia, 140 00
Site CZ42013
Sternberk, Czechia, 78501
Site CZ42009
Uherske Hradiste, Czechia, 686 08
Site CZ42006
Usti nad Labem, Czechia, 40001
Denmark
Site DK45013
Aarhus, Denmark, 8200
Estonia
Site EE37201
Parnu, Estonia, 80010
Finland
Site FI35801
Kouvola, Finland, 45200
Germany
Site DE49034
Munich, Bavaria, Germany, 81377
Site DE49031
Bergisch Gladbach, Northwest, Germany, 51427
Site DE49032
Duisburg, NRW, Germany, 47179
Site DE49003
Lutherstadt Eisleben, Sachsen Anhalt, Germany, 06295
Site DE49013
Leipzig, Sachsen, Germany, 04105
Site DE49008
Bad Ems, Germany, 56130
Site DE49002
Duisburg, Germany, 47051
Site DE49010
Ganderkesee, Germany, 27777
Site DE49011
Halle (Saale), Germany, 06132
Site DE49001
Neustadt I. Sachsen, Germany, 01844
Site DE49026
Rostock, Germany, 18107
Site DE49014
Sangerhausen, Germany, 06526
Hungary
Site HU36007
Kecskemet, Bacs-Kiskun Megye, Hungary, 6000
Site HU36005
Pecs, Baranya Megye, Hungary, 7621
Site HU36003
Csongrad, Csongrad Megye, Hungary, 6640
Site HU36001
Szentes, Csongrad Megye, Hungary, 6600
Site HU36013
Sopron, Gyor-Moson Sopron, Hungary, 9400
Site HU36012
Veszprem, Veszprem Megye, Hungary, 8200
Italy
Site IT39022
Ancona, Italy, 60126
Site IT39007
Avellino, Italy, 83100
Site IT39001
Latina, Italy, 04100
Site IT39020
Milano, Italy, 20100
Korea, Republic of
Site KR82004
Suwon-si, Gyeonggi-do, Korea, Republic of, 443-721
Site KR82014
Bucheon-Si, Gyunggido, Korea, Republic of, 420-767
Site KR82012
Seoul, Gyunggido, Korea, Republic of, 143-729
Site KR82010
Jeonju-si, Jeollabuk-do South Korea, Korea, Republic of, 561-712
Site KR82006
Busan, Korea, Republic of, 602-715
Site KR82016
Busan, Korea, Republic of, 602-739
Site KR82005
Daegu, Korea, Republic of, 705-717
Site KR82029
Daegu, Korea, Republic of, 705-718
Site KR82019
Daejeon, Korea, Republic of, 301-721
Site KR82023
Incheon, Korea, Republic of, 405760
Site KR82003
Seoul, Korea, Republic of, 05505
Site KR82021
Seoul, Korea, Republic of, 100-380
Site KR82020
Seoul, Korea, Republic of, 110-744
Site KR82030
Seoul, Korea, Republic of, 120-752
Site KR82013
Seoul, Korea, Republic of, 134-701
Site KR82017
Seoul, Korea, Republic of, 134-872
Site KR82002
Seoul, Korea, Republic of, 135-710
Site KR82008
Seoul, Korea, Republic of, 135-720
Site KR82015
Seoul, Korea, Republic of, 136-075
Site KR82001
Seoul, Korea, Republic of, 137-701
Latvia
Site LV37102
Liepaja, Latvia, LV-3401
Site LV37103
Olaine, Latvia, LV-2114
Site LV37105
Riga, Latvia, LV-1002
Lithuania
Site LT37008
Kaunas, Lithuania, 47144
Site LT37004
Kaunas, Lithuania, 50009
Site LT37011
Kaunas, Lithuania, LT49449
Site LT37012
Klaipeda, Lithuania, LT-92288
Site LT37010
Vilnius, Lithuania, 10207
Site LT37003
Vilnius, Lithuania, LT-01118
Site LT37007
Vilnius, Lithuania, LT-08661
Site LT37009
Vilnius, Lithuania, LT-09108
Malaysia
Site MY60002
Petaling Jaya, Malaysia, 47500
Mexico
Site MX52003
Mexico City, DF, Mexico, 06700
Netherlands
Site NL31006
Enschede, NL, Netherlands, 7513ER
Site NL31002
Amsterdam, Netherlands, 1105 AZ
Site NL31005
Nijmegen, Netherlands, 6532 SZ
Site NL31010
Sneek, Netherlands, 8601 ZK
New Zealand
Site NZ64001
Christchurch, Canterbury, New Zealand, 8013
Site NZ64002
Nelson, New Zealand, 7010
Site NZ64003
Tauranga, New Zealand, 3140
Site NZ64006
Whangarei, New Zealand, 0112
Norway
Site NO47007
Alesund, Norway, 6003
Site NO47006
Hamar, Norway, 2317
Site NO47008
Lierskogen, Norway, 3420
Poland
Site PL48018
Bialystok, Poland, 15-351
Site PL48013
Chorzow, Poland, 41-500
Site PL48014
Gdynia, Poland, 81-384
Site PL48004
Lodz, Poland, 90-302
Site PL48010
Lublin, Poland, 20-632
Site PL48011
Myslowice, Poland, 41-400
Site PL48016
Opole, Poland, 45-086
Site PL48005
Piaseczno, Poland, 05-500
Site PL48012
Warsaw, Poland, 00-909
Site PL48003
Warszawa, Poland, 02-507
Site PL48001
Warszawa, Poland, 02-929
Site PL48019
Wrocław, Poland, 50-088
Romania
Site RO40014
Cluj-Napoca, Cluj, Romania, 400046
Site RO40004
Bucuresti, Romania, 042122
Site RO40001
Bucuresti, Romania, 50659
Site RO40005
Bucuresti, Romania, 50659
Site RO40010
Sibiu, Romania, 550245
Site RO40002
Timisoara, Romania, 300736
Russian Federation
Site RU70015
Kazan, Russian Federation, 420097
Site RU70023
Penza, Russian Federation, 440026
Site RU70019
Saint Petersburg, Russian Federation, 194354
Site RU70002
Saint Petersburg, Russian Federation, 197089
Site RU70022
Saint Petersburg, Russian Federation, 198103
Site RU70014
St. Petersburg, Russian Federation, 199178
Site RU70018
Ufa, Russian Federation, 450096
Singapore
Site SG65002
Singapore, Singapore, 169608
Site SG65003
Singapore, Singapore, 229899
Slovakia
Site SK42105
Bratislava, Slovakia, 82101
Site SK42107
Kosice, Slovakia, 04001
Site SK42101
Kosice, Slovakia, 04013
Site SK42103
Nitra, Slovakia, 949 01
Site SK42108
Poprad, Slovakia, 05801
Site SK42104
Prešov, Slovakia, 080 01
Site SK42102
Trencin, Slovakia, 91101
Site SK42106
Trencin, Slovakia, 91101
Slovenia
Site SI38604
Murska Sobota, Slovenia, 9000
South Africa
Site ZA27001
Centurion, Gauteng, South Africa, 0157
Site ZA27002
Roodepoort, Gauteng, South Africa, 1709
Site ZA27006
Durban, Kwa Zulu Natal, South Africa, 4001
Site ZA27013
Meyerspark, Pretoria, South Africa, 0184
Site ZA27007
Paarl, Western Cape, South Africa, 7646
Spain
Site ES34004
Madrid, Spain, 28031
Site ES34015
Madrid, Spain, 28044
Site ES34009
Madrid, Spain, 28046
Site ES34002
Valencia, Spain, 46026
Sweden
Site SE46007
Boras, Sweden, 506 30
Site SE46005
Malmo, Sweden, 211 52
Site SE46016
Stockholm, Sweden, 111 57
Site SE46012
Stockholm, Sweden, 141 86
Site SE46003
Stockholm, Sweden, 182 88
Site SE46009
Uppsala, Sweden, 753 19
Thailand
Site TH66008
Bangkok, Thailand, 10400
Site TH66009
Khon Kaen, Thailand, 40002
Ukraine
Site UA38002
Cherenigiv, Ukraine, 14034
Site UA38015
Chernivtsi, Ukraine, 58002
Site UA38013
Dnepropetrovsk, Ukraine, 49005
Site UA38007
Kiev, Ukraine, 02232
Site UA38003
Kyiv, Ukraine, 02660
Site UA38010
Kyiv, Ukraine, 04053
Site UA38008
Zaporizhzhya, Ukraine, 69600
United Kingdom
Site GB44001
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Site GB44006
Plymouth, United Kingdom, PL6 8DH
Site GB44009
Watford, United Kingdom, WD25 7NL
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
Layout table for investigator information
Study Director: Medical Director Astellas Pharma Europe B.V.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT02045862     History of Changes
Other Study ID Numbers: 178-CL-102
2012-005736-29 ( EudraCT Number )
First Posted: January 27, 2014    Key Record Dates
Results First Posted: June 6, 2018
Last Update Posted: September 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL: https://www.clinicalstudydatarequest.com/
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
Solifenacin Succinate
Mirabegron
Urinary Incontinence
Combination Therapy
Urgency
Nocturia
Overactive Bladder
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder, Overactive
Urologic Diseases
Urinary Bladder Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Mirabegron
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents