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This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder (SYNERGY)

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ClinicalTrials.gov Identifier: NCT01972841
Recruitment Status : Completed
First Posted : October 31, 2013
Results First Posted : June 12, 2018
Last Update Posted : November 1, 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 two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3527 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder
Actual Study Start Date : November 5, 2013
Actual Primary Completion Date : October 22, 2015
Actual Study Completion Date : October 22, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1: Solifenacin 5 mg + Mirabegron 25 mg
Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.
Drug: Solifenacin succinate
Oral tablet
Other Names:
  • Vesikur
  • Vesitrim
  • YM905
  • Vesicare

Drug: Mirabegron
Oral tablet
Other Names:
  • YM178
  • Betmiga
  • Betanis
  • Myrbetriq

Drug: Placebo to match mirabegron
Oral tablet

Experimental: 2: Solifenacin 5 mg + Mirabegron 50 mg
Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
Drug: Solifenacin succinate
Oral tablet
Other Names:
  • Vesikur
  • Vesitrim
  • YM905
  • Vesicare

Drug: Mirabegron
Oral tablet
Other Names:
  • YM178
  • Betmiga
  • Betanis
  • Myrbetriq

Drug: Placebo to match mirabegron
Oral tablet

Placebo Comparator: 3: Placebo
Participants who received matching placebo once a day for 12 weeks.
Drug: Placebo to match solifenacin succinate
Oral tablet

Drug: Placebo to match mirabegron
Oral tablet

Active Comparator: 4: Solifenacin 5 mg
Participants who received solifenacin 5 mg once a day for 12 weeks.
Drug: Solifenacin succinate
Oral tablet
Other Names:
  • Vesikur
  • Vesitrim
  • YM905
  • Vesicare

Drug: Placebo to match mirabegron
Oral tablet

Active Comparator: 5:Mirabegron 25 mg
Participants who received mirabegron 25 mg once a day for 12 weeks.
Drug: Mirabegron
Oral tablet
Other Names:
  • YM178
  • Betmiga
  • Betanis
  • Myrbetriq

Drug: Placebo to match solifenacin succinate
Oral tablet

Drug: Placebo to match mirabegron
Oral tablet

Active Comparator: 6: Mirabegron 50 mg
Participants who received mirabegron 50 mg once a day for 12 weeks.
Drug: Mirabegron
Oral tablet
Other Names:
  • YM178
  • Betmiga
  • Betanis
  • Myrbetriq

Drug: Placebo to match solifenacin succinate
Oral tablet

Drug: Placebo to match mirabegron
Oral tablet




Primary Outcome Measures :
  1. Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours [ Time Frame: Baseline and EoT (up to 12 weeks) ]
    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 per day on valid diary days during the 7-day micturition diary period.

  2. Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours [ Time Frame: Baseline and EoT (up to 12 weeks) ]
    A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.


Secondary Outcome Measures :
  1. Change From Baseline to EoT in Mean Volume Voided Per Micturition [ Time Frame: Baseline and EoT (up to 12 weeks) ]
    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 EoT (up to 12 weeks) ]
    The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consisted 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 indicates an improvement.

  3. Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS) [ Time Frame: Baseline and EoT (up to 12 weeks) ]
    The TS-VAS was a visual analogue scale which asked 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. Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The number of incontinence episodes was calculated as the total number of incontinence episodes on valid diary days recorded during the 7-day micturition diary period.

  5. Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes [ Time Frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks) ]
  6. Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours [ Time Frame: Baseline and weeks 4, 8 and 12 ]
  7. Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours [ Time Frame: Baseline and weeks 4, 8 and 12 ]
  8. Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition [ Time Frame: Baseline and weeks 4, 8 and 12 ]
  9. Change From Baseline to EoT in Corrected Micturition Frequency [ Time Frame: Baseline and Week 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.

  10. Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    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 number of times a participant recorded an urgency incontinence episode on valid diary days during the 7-day micturition diary period prior to each visit.

  11. Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes [ Time Frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks) ]
  12. Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours [ Time Frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.

  13. Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours [ Time Frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    An urgency episode was a complaint of a sudden, compelling desire to pass urine, which was difficult to defer; it was recorded when a micturition or incontinence episode was recorded and the severity of urinary urgency recorded was 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS). The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.

  14. Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    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 went to bed with the intention to sleep until the time the patients got 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 on valid diary days during the 7-day micturition diary period prior to each visit.

  15. Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes [ Time Frame: Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks) ]
  16. Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours [ Time Frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The mean number of nocturia episodes per 24hr was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.

  17. Number of Pads Used at Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8 and 12 (up to 12 weeks) ]
    The number of pads used was the number of times a participant recorded a new pad used on valid diary days during the 7-day micturition diary period prior to each visit.

  18. Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used [ Time Frame: Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks) ]
  19. Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours [ Time Frame: Baseline and weeks 4, 8 and 12 (up to 12 weeks) ]
    The mean number of pads used per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.

  20. Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded.

  21. Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8,12 and EoT (up to 12 weeks) ]
    The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with less than 8 micturitions per day.

  22. Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    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.

  23. Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC) [ Time Frame: Baseline and weeks 4, 8, 12, EoT (up to 12 weeks) ]
    The PPBC was 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.

  24. Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score [ Time Frame: Baseline and weeks 4, 8 and 12 ]
    The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion in the OAB-q (seen in this outcome measure) consisted 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.

  25. Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score [ Time Frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion in the OAB-q (seen in this outcome measure) consisted of 25 HRQL items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction), scored 1-6. The total HRQoL 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.

  26. Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping [ Time Frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The Coping score was calculated by adding 8 response 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.

  27. Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern [ Time Frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The Concern score was calculated by adding 7 response 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.

  28. Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep [ Time Frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The Sleep score was calculated by adding 5 response 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.

  29. Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social [ Time Frame: Weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The Social score was calculated by adding 5 response 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.

  30. Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT [ Time Frame: Week 12 and EoT (up to 12 weeks) ]
    The PGIC was 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).

  31. PGIC Scale: Impression in General Health at Week 12 and EoT [ Time Frame: Week 12 and EoT (up to 12 weeks) ]
    The PGIC was 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. Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility [ Time Frame: Baseline and EoT (up to 12 weeks) ]
    The EQ-5D questionnaire was 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 had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

  33. Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care [ Time Frame: Baseline and EoT (up to 12 weeks) ]
    The EQ-5D questionnaire was 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 had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

  34. Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities [ Time Frame: Baseline and EoT (up to 12 weeks) ]
    The EQ-5D questionnaire was 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 had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

  35. Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort [ Time Frame: Baseline and EoT (up to 12 weeks) ]
    The EQ-5D questionnaire was 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 had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

  36. Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression [ Time Frame: Baseline and EoT (up to 12 weeks) ]
    The EQ-5D questionnaire was 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 had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

  37. Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed [ Time Frame: Baseline and week 12 and EoT (up to 12 weeks) ]
    The WPAI:SHP was 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 were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.

  38. Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working [ Time Frame: Baseline and week 12 and EoT (up to 12 weeks) ]
  39. Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment [ Time Frame: Baseline and week 12 and EoT (up to 12 weeks) ]
  40. Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment [ Time Frame: Baseline and week 12 and EoT (up to 12 weeks) ]
  41. Change From Baseline to Weeks 4, 8 and 12 in TS-VAS [ Time Frame: Baseline and week 4, 8 and 12 ]
    The TS-VAS was a visual analogue scale which asked 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.

  42. Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 3 days prior to weeks 4, 8, 12 and EoT.

  43. Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).

  44. Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).

  45. Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The percentage of participants with ≥ 50% decrease from baseline in mean number of incontinence episodes per 24 hours at each time point (weeks 4, 8, 12 and EoT).

  46. Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8 , 12 and EoT (up to 12 weeks) ]
    The percentage of participants with micturition frequency normalization was defined as any participant who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 h postbaseline at weeks 4, 8, 12 and EoT.

  47. Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 7 days prior to weeks 4, 8, 12 and EoT.

  48. Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The percentage of participants with ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

  49. Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The percentage of participants with a major (≥ 2 points) improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

  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 Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score at weeks 4, 8, 12 and EoT.

  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 Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q HRQL total score at weeks 4, 8, 12 and EoT.

  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 Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

  53. Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

  54. Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT [ Time Frame: Weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the HRQL total score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

  55. 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 16 weeks) ]
    A TEAE refered to an adverse event (AE; defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment) which started or worsened in the period from first double-blind medication intake until 14 days after the last double-blind medication intake. Serious TEAEs with a start date reported until 30 days after the last double-blind medication intake were also summarized as TEAEs, and also included serious TEAEs upgraded by the sponsor based on review of the sponsor's list of Always Serious terms if any upgrade was done. Drug-related TEAEs may be possible or probable, as assessed by the investigator, or records where relationship is missing.

  56. Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume [ Time Frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks) ]
    PVR volume was assessed by ultrasonography or a bladder scanner.

  57. Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP) [ Time Frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks) ]
    Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.

  58. Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP) [ Time Frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks) ]
    Vital signs (blood pressure and pulse rate) were monitored using ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.

  59. Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR) [ Time Frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks) ]
    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.

  60. Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window [ Time Frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks) ]
    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax (time to maximum concentration) window of mirabegron and solifenacin was from 4-6 hours postdose.

  61. Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window [ Time Frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks) ]
    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.

  62. Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window [ Time Frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks) ]
    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.

  63. Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT [ Time Frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks) ]
    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.

  64. Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT [ Time Frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks) ]
    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.

  65. Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT [ Time Frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks) ]
    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.

  66. Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference [ Time Frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks) ]
    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.

  67. Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference [ Time Frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks) ]
    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.

  68. Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference [ Time Frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks) ]
    Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.



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:

  • 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;
  • Subject had symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months;

Exclusion Criteria:

  • Subject had significant PVR volume (> 150 mL);
  • Subject had a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and Parkinson's disease with autonomic component or bladder involvement). An autonomic component could be inferred when autonomic functions were affected, including heart rate, blood pressure, perspiration and digestion.
  • Subject had an indwelling catheter or practices intermittent self catheterization.
  • Subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis.
  • Subject had received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
  • Subject had moderate to severe hepatic impairment
  • Subject had severe renal impairment
  • Subject had a clinically significant abnormal ECG
  • Subject had a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
  • Subject had an average QTcF interval > 450 ms for males or > 470 ms for females based on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
  • Subject had severe hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.

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): NCT01972841


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
Site US10049 Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
Site US10112 TFI, LLC
Mobile, Alabama, United States, 36608
United States, Arizona
Site US10104 Clinical Research Advantage, Inc.
Chandler, Arizona, United States, 85224
Site US10021 Beach Clinical Studies
Phoenix, Arizona, United States, 85051
United States, California
Site US10122 Orange County Research Institute
Anaheim, California, United States, 92801
Site US10098 Skyline Research
Cerritos, California, United States, 90703
Site US10539 Citrus Valley Medical Research
Glendora, California, United States, 91741
Site US10082 American Clinical Trials
Hawaiian Gardens, California, United States, 90716
Site US10132 Axis Clinical Trials
Los Angeles, California, United States, 90017
Site US10133 Axis Clinical Trials
Los Angeles, California, United States, 90036
Site US10536 Stanford School of Medicine
Palo Alto, California, United States, 93404
Site US10149 Bayview Research Group
Paramount, California, United States, 90723
Site US10559 UC Davis Medical Center
Sacramento, California, United States, 95817
Site US10003 San Diego Clinical Trials
San Diego, California, United States, 92120
Site US10545 San Diego Institute for Sexual Medicine
San Diego, California, United States, 92120
Site US10106 West Coast Clinical Research
Tarzana, California, United States, 91356
Site US10595 Bayview Research Group
Valley Village, California, United States, 91607
United States, Colorado
Site US10034 Urology Center of Colorado
Denver, Colorado, United States, 80211
Site US10070 Physicians' Research Options/Red Rocks OB/GYN
Lakewood, Colorado, United States, 80228
Site US10053 Western Clinical Research, Inc.
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Site US10128 Clinical Research Center of CT
Danbury, Connecticut, United States, 06810
Site US10018 Grove Hill Clinical Research
New Britain, Connecticut, United States, 06052
Site US10170 Yale - New Haven Hospital West Haven VAMC
New Haven, Connecticut, United States, 06510
Site US10123 Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
United States, Florida
Site US10060 Meridien Research
Bradenton, Florida, United States, 34208
Site US10097 A.G.A. Clinical Trials DBA Neostart Group
Hialeah, Florida, United States, 33012
Site US10148 Best Quality Research, Inc.
Hialeah, Florida, United States, 33016
Site US10153 Palmetto Professional Research
Hialeah, Florida, United States, 33016
Site US10159 Urological Research Network
Hialeah, Florida, United States, 33016
Site US10534 South Florida Medical Research
Hialeah, Florida, United States, 33016
Site US10535 South Florida Medical Research
Homestead, Florida, United States, 33030
Site US10165 East Coast Institute for Research
Jacksonville, Florida, United States, 32216
Site US10091 Health Awareness
Jupiter, Florida, United States, 33458
Site US10150 Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States, 34652
Site US10158 Renstar Medical Research
Ocala, Florida, United States, 34471
Site US10124 Winter Park Urology Associates
Orlando, Florida, United States, 32803
Site US10134 Compass Research, LLC
Orlando, Florida, United States, 32806
Site US10009 South Broward Research
Pembroke Pines, Florida, United States, 33027
Site US10540 Demaur Clinical Research, INC
Pembroke Pines, Florida, United States, 33028
Site US10554 Private Practice
Plantation, Florida, United States, 33317
Site US10095 Florida Urology Specialists
Sarasota, Florida, United States, 34237
Site US10010 Southeastern Research Group, Inc
Tallahassee, Florida, United States, 32308
Site US10014 Private Practice
Wellington, Florida, United States, 33449
United States, Georgia
Site US10037 Atlanta Medical Research Institute
Alpharetta, Georgia, United States, 30005
Site US10127 Perimeter North Medical Research, Inc.
Roswell, Georgia, United States, 30076
Site US10120 WR-Mount Vernon Clinical Research
Sandy Springs, Georgia, United States, 30328
United States, Kansas
Site US10024 GTC Research
Shawnee Mission, Kansas, United States, 66218
Site US10078 Heartland Research Associates, LLC
Wichita, Kansas, United States, 67205
United States, Louisiana
Site US10088 Centex Studies, Inc.
Lake Charles, Louisiana, United States, 70601
Site US10074 Medpharmics, LLC
Metairie, Louisiana, United States, 70006
Site US10025 Regional Urology, LLC
Shreveport, Louisiana, United States, 71106
United States, Maryland
Site US10558 Chesapeake Urology Research Associates
Glen Burnie, Maryland, United States, 21061
Site US10560 Chesapeake Urology Research Associates
Owings Mills, Maryland, United States, 21117
United States, Massachusetts
Site US10282 Boston Clinical Trials
Boston, Massachusetts, United States, 02131
Site US10114 Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States, 02472
United States, Michigan
Site US10152 Female Pelvic Medicine & Urogynecology Institute
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Site US10542 Adult & Pediatric Urology Group
Sartell, Minnesota, United States, 56377
United States, Montana
Site US10110 Montana Health Research Institute, Inc.
Billings, Montana, United States, 59102
Site US10154 Montana Medical Research Inc
Missoula, Montana, United States, 59801
United States, Nebraska
Site US10553 Women's Clinic of Lincoln
Lincoln, Nebraska, United States, 68510
United States, Nevada
Site US10140 IVCTLV
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Site US10002 Urology Center Research Institute
Englewood, New Jersey, United States, 07631
Site US10051 AdvancedMed Research
Lawrenceville, New Jersey, United States, 08648
Site US10047 Lawrence OBGYN Associates
Lawrenceville, New Jersey, United States, 86480
Site US10162 Phoenix OB-GYN Associates, LLC
Moorestown, New Jersey, United States, 08057
United States, New Mexico
Site US10011 Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States, 87102
Site US10015 Urology Group of New Mexico
Albuquerque, New Mexico, United States, 87109
United States, New York
Site US10077 Northeast Urogynecology
Albany, New York, United States, 12205
Site US10089 Maimonides Medical Center
Brooklyn, New York, United States, 11220
Site US10026 AccuMed Research Associates
Garden City, New York, United States, 11530
Site US10040 Premier Medical Group Of The Hudson Valley
Kingston, New York, United States, 12401
Site US10073 Manhattan Medical Research Practice, PLLC
New York, New York, United States, 10016
Site US10249 New York Clinical Trials
New York, New York, United States, 10018
Site US10168 Weill Cornell Medical College
New York, New York, United States, 10065
Site US10126 Premier Medical Group
Newburgh, New York, United States, 12550
Site US10028 Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States, 12601
Site US10593 Upstate Clinical Research Associates LLC
Williamsville, New York, United States, 14221
United States, North Carolina
Site US10076 Carolina Clinical Trials
Concord, North Carolina, United States, 28025
Site US10129 PMG Research of Raleigh
Raleigh, North Carolina, United States, 27609
Site US10549 Associated Urologists of North Carolina
Raleigh, North Carolina, United States, 27612
Site US10062 Piedmont Medical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Site US10050 Rapid Medical Research, Inc.
Cleveland, Ohio, United States, 44122
Site US10033 Ohio Clinical Research
Lyndhurst, Ohio, United States, 44124
Site US10067 Family Practice Center of Wadsworth
Wadsworth, Ohio, United States, 44281
Site US10551 The Christ Hospital
West Chester, Ohio, United States, 45069
United States, Oklahoma
Site US10109 Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Site US10541 Sunstone Medical Research
Medford, Oregon, United States, 97504
United States, Pennsylvania
Site US10008 Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania, United States, 19004
Site US10045 Lancaster Urology
Lancaster, Pennsylvania, United States, 17604
Site US10017 Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, United States, 19114
Site US10167 University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Site US10250 Preferred Primary Care Physicians Inc.
Pittsburgh, Pennsylvania, United States, 15236
Site US10248 Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania, United States, 15243
Site US10063 Preferred Primary Care Physician Research
Uniontown, Pennsylvania, United States, 15401
Site US10012 Advanced Clinical Concepts
West Reading, Pennsylvania, United States, 19611
United States, South Carolina
Site US10166 Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Site US10094 University Medical Group
Greer, South Carolina, United States, 29650
Site US10046 Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States, 29464
Site US10079 PMG Research of Charleston, LLC
Mount Pleasant, South Carolina, United States, 29464
Site US10117 Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Site US10023 Hillcrest Clinical Research, LLC
Simpsonville, South Carolina, United States, 29681
Site US10101 Palmetto Clinical Research
Summerville, South Carolina, United States, 29485
United States, Tennessee
Site US10006 Holston Medical Group
Kingsport, Tennessee, United States, 37660
United States, Texas
Site US10084 Dynamed Clinical Research of Austin,LLC dba DM Clinical Resc
Austin, Texas, United States, 78745
Site US10066 Texas Urology PA
Carrollton, Texas, United States, 75010
Site US10065 Advanced Research Associates
Corpus Christi, Texas, United States, 78414
Site US10085 Centex Studies, Inc.
Houston, Texas, United States, 77062
Site US10108 Clinical Trial Network
Houston, Texas, United States, 77074
Site US10219 Methodist Urology Associates
Houston, Texas, United States, 77094
Site US10093 Pioneer Research Solutions, Inc.
Houston, Texas, United States, 77098
Site US10090 Protenium Clinical Research, LLC
Hurst, Texas, United States, 76054
Site US10105 Clinical Trials of Texas
San Antonio, Texas, United States, 78229
Site US10111 Clinical Trials of Texas
San Antonio, Texas, United States, 78229
United States, Utah
Site US10092 Physicians' Research Options/Salt Lake Women's Center
Sandy, Utah, United States, 84070
United States, Virginia
Site US10032 National Clinical Research Inc.
Richmond, Virginia, United States, 23294
Site US10064 The Group for Women
Virginia Beach, Virginia, United States, 23456
Site US10083 Urology of Virginia, PLLC.
Virginia Beach, Virginia, United States, 23462
United States, Washington
Site US10013 Seattle Urology Research Center
Burien, Washington, United States, 98166
Site US10004 Integrity Medical Research, LLC
Mountlake Terrace, Washington, United States, 98043
Site US10155 Seattle Women's Health, Research, Gynecology
Seattle, Washington, United States, 98105
Site US10135 Walla Walla Clinic
Walla Walla, Washington, United States, 99362
Argentina
Site AR54005 IUBA - Instituto Urologico de Buenos Aires
Buenos Aires, Argentina, 1419
Site AR54003 Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1181ACH
Site AR54006 Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1181ACH
Site AR54001 CDU - Centro de Urología
Ciudad Autónoma Buenos Aires, Argentina, C1120AAT
Site AR54004 Instituto de Investigaciones Clnicas Rosario
Rosario Provincia De Santa Fe, Argentina, 2000
Australia
Site AU61026 Ballarat Urology
Ballarat, Australia, 3350
Site AU61022 Brisbane South Clinical Research Centre
Brisbane, Australia, 4152
Site AU61005 Hunter Clinical Research
Broadmeadow, Australia, 2292
Site AU61015 Repatriation General Hospital
Daw Park, Australia, 5041
Site AU61025 Western Health
Footscray, Australia, 3011
Site AU61012 Cabrini Hospital
Malvern, Australia, 3144
Site AU61010 Nambour General Hospital
Nambour, Australia, 4560
Site AU61002 The Royal Womens Hospital
Parkville, Australia, 3052
Site AU61004 Keogh Institute for Medical Research
Perth, Australia, 6009
Site AU61007 Prince of Wales Hospital
Randwick, Australia, 2031
Site AU61008 Epworth Healthcare
Richmond, Australia, 3121
Site AU61019 AusTrialsSherwood
Sherwood, Australia, 4075
Site AU61017 Healthpac Medical Centre
Sydney, Australia, 2000
Site AU61021 Royal Hospital for Women
Sydney, Australia, 2031
Site AU61011 Illawarra Health and Medical Research Institute
Wollongong, Australia, 2522
Belgium
Site BE32004 Gent University Hospital
Gent, Belgium, 9000
Site BE32011 Universitaire Ziekenhuizen Leuven
Leuven, Belgium, 3000
Site BE32014 Hart Ziekenhuis
Roeselare, Belgium, 8800
Site BE32012 Sint-Trudo Ziekenhuis, Campus Sint Jozef/Sint-Anna
Sint-Truiden, Belgium, 3800
Bulgaria
Site BG35904 University Hospital (UMHAT) - George Stranski
Pleven, Bulgaria, 5800
Site BG35908 MHAT Plovdiv AD
Plovdiv, Bulgaria, 4003
Site BG35902 MHAT Ruse
Ruse, Bulgaria, 7002
Site BG35905 MHAT Alexandrovska Hospital
Sofia, Bulgaria, 1431
Site BG35903 MHATEM Pirogov
Sofia, Bulgaria, 1606
Site BG35906 UMHAT Varna
Varna, Bulgaria, 9000
Site BG35910 MHAT
Veliko Tarnovo, Bulgaria, 5000
Canada, Alberta
Site CA15029 Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Site CA15035 Glenrose Rehabilitation Hospital
Edmonton, Alberta, Canada, T6G 2P4
Canada, British Columbia
Site CA15033 Prohealth
Vancouver, British Columbia, Canada, V5Z 4E1
Canada, New Brunswick
Site CA15008 Private Practice
Saint John, New Brunswick, Canada, E2L 3J8
Canada, Ontario
Site CA15001 The Male/Female Health & Research Centre
Barrie, Ontario, Canada, L4M 7G1
Site CA15006 Bramalea Medical Centre
Brampton, Ontario, Canada, L6T 4S5
Site CA15003 Brantford Urology Research
Brantford, Ontario, Canada, N3R 4N3
Site CA15042 G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, Canada, L7N 3V2
Site CA15044 McMaster Institute of Urology
Hamilton, Ontario, Canada, L8N 4A6
Site CA15031 Centre for Applied Urology Research (CAUR)
Kingston, Ontario, Canada, K7L 3J7
Site CA15007 Eunoia2 Incorporated
Kitchener, Ontario, Canada, N2N 2B9
Site CA15034 Oxford/Richmond Medical
London, Ontario, Canada, N6A 5R9
Site CA15032 Stanley Flax Medical Prof Corp
North York, Ontario, Canada, M2J 1V1
Site CA15013 Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
Site CA15004 Primehealth Clinical Research
Toronto, Ontario, Canada, M4S 1Y2
Site CA15002 Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Site CA15026 Rhodin Recherche Clinique
Drummondville, Quebec, Canada, J2B 7T1
Site CA15015 Recherches Cliniques Theradev, Inc.
Granby, Quebec, Canada
Site CA15021 Urology South Shore Research
Greenfield Park, Quebec, Canada, J4V 2H3
Site CA15030 UroLaval
Laval, Quebec, Canada, H7G 2E6
Site CA15040 RechercheGCP Research
Montreal, Quebec, Canada, H2R1V6
Site CA15020 Diex Research Montreal
Montreal, Quebec, Canada, H4N 3C5
Site CA15010 Ultra Med Research, Inc.
Point-Claire, Quebec, Canada, H9R 4S3
Site CA15027 Diex Research Sherbrooke Inc
Sherbrooke, Quebec, Canada, J1H 1Z1
Site CA15039 Pro-recherche
St-Romuald, Quebec, Canada, G6W 5M6
Canada
Site CA15025 Clinique RSF Inc.
Quebec, Canada, G1S 2L6
China, Fujian
Site CN86017 Affiliated Union Hospital of Fujian Medical Uni.
Fuzhou, Fujian, China, 350001
China
Site CN86025 Beijing Friendship Hospital
Beijing, China, 100050
Site CN86009 Peking University 3rd Hospital
Beijing, China, 100191
Site CN86013 Beijing Hospital
Beijing, China, 100730
Site CN86014 The First Hospital Bethune of Jilin University
Changchun, China, 130021
Site CN86002 Changsha Central Hospital
Changsha, China, 410008
Site CN86028 General Hospital of Chengdu Military Region of PLA
Chengdu, China
Site CN86029 Southwest Hospital (Chongqing)
Chongqing, China, 400038
Site CN86016 Guangzhou First People's Hospital
Guangzhou, China, 510180
Site CN86027 Second Hospital of Lanzhou University
Lan Zhou, China, 730030
Site CN86030 Lanzhou University First Hospital
Lanzhou, China
Site CN86020 The First Affiliated Hospital of NanChang Univers
Nanchang, China, 330006
Site CN86023 Nanjing First Hospital
Nanjing, China, 210006
Site CN86021 HuaDong Hosipital Affiliated to Fudan University
Shanghai, China, 200040
Site CN86003 Shanghai Renji Hospital
Shanghai, China, 200127
Site CN86012 The Fifth People's Hospital of Shanghai
Shanghai, China, 200240
Site CN86011 The Second Affiliated Hospital of Soochow Universi
Suzhou, China, 215004
Site CN86010 1st Affiliated Hosptital of Suchow University
Suzhou, China, 215006
Site CN86026 The First Affiliated Hospital of Wenzhou Medical C
Wenzhou, China, 325000
Site CN86022 Tongji Hospital, Tongji Medical College of Hust
Wuhan, China, 430030
Site CN86015 Zhongnan Hospital of Wuhan University
Wuhan, China, 430071
Site CN86018 Wuxi People's Hospital
Wuxi, China, 214023
Colombia
Site CO57003 Hospital Pablo Tobón Uribe
Medellin, Antioquia, Colombia
Site CO57004 Instituto de Coloproctologia ICO SAS
Medellin, Colombia
Czechia
Site CZ42015 Centrum ambulantni gynekologie a primarni pece
Brno, Czechia, 602 00
Site CZ42003 SANUS
Hradec Kralove, Czechia, 500 02
Site CZ42001 Fakultni Nemocnice Hradec Kralove
Hradec Kralove, Czechia, 50005
Site CZ42002 Hospital Jihlava
Jihlava, Czechia, 586 33
Site CZ42011 Hospital Novy Jicin
Novy Jicin, Czechia, 741 01
Site CZ42010 G-centrum Olomouc S.R.O.
Olomouc, Czechia, 772 00
Site CZ42014 Private Practice
Ostrava, Czechia, 700 30
Site CZ42005 Research Site s.r.o.
Plzen, Czechia, 301 00
Site CZ42007 Uro-Santé/Nová Brumlovka
Praha 4, Czechia, 140 00
Site CZ42013 Urology Clinic
Sternberk, Czechia, 78501
Site CZ42009 Hospital Uherské Hradiště a.s.
Uherske Hradiste, Czechia, 686 08
Site CZ42006 Private Practice
Usti nad Labem, Czechia, 40001
Denmark
Site DK45012 Aalborg Sygehus Nord
Aalborg, Denmark, 9000
Site DK45013 University Hospital of Aarhus, Skejby
Aarhus, Denmark, 8200
Estonia
Site EE37201 Parnu Hospital
Parnu, Estonia, 80010
Site EE37205 West Tallinn Central Hospital
Tallinn, Estonia, 10617
Site EE37202 Tartu University Hospital
Tartu, Estonia, 51014
Finland
Site FI35801 Kouvolan Lääkäriasema
Kouvola, Finland, 45200
Site FI35803 Oulu University Hospital
Oulu, Finland, 90029
Site FI35802 Meilahti Hospital
Vantaa, Finland, 01400
France
Site FR33007 Centre Hospitalier Louis Pasteur
Colmar Cedex, France, 68024
Site FR33010 CHU Hopital du Bocage
Dijon, France, 21079
Site FR33008 CHU Nantes
Nantes Cedex 1, France, 44035
Site FR33002 CHU Carémeau
Nimes Cedex, France, 30029
Site FR33001 Hopital Tenon
Paris Cedex 20, France, 75970
Site FR33024 Hopital Tenon
Paris Cedex 20, France, 75970
Site FR33013 Hopital Saint Louis
Paris, France, 75475
Site FR33011 Centre Hospitalier Lyon Sud
Pierre Benite Cedex, France, 69495
Site FR33012 Hopital Foch
Suresnes, France, 92151
Site FR33005 Hopital Bretonneau
Tours Cedex 9, France, 37044
Germany
Site DE49008 Private Practice
Bad Ems, Germany, 56130
Site DE49031 Urologisches Zentrum Refrath
Bergisch Gladbach, Germany, 51427
Site DE49033 Universitsy Clinic Bonn
Bonn, Germany, 53217
Site DE49002 Private Practice
Duisburg, Germany, 47051
Site DE49032 Urologicum Duisburg
Duisburg, Germany, 47179
Site DE49010 Private Practice
Ganderkesee, Germany, 27777
Site DE49011 Private Practice
Halle (Saale), Germany, 06132
Site DE49013 Private Practice
Leipzig, Germany, 04105
Site DE49003 Private Practice
Lutherstadt Eisleben, Germany, 6295
Site DE49034 LMU Muenchen
Munich, Germany, 81377
Site DE49001 Private Practice
Neustadt I. Sachsen, Germany, 1844
Site DE49026 Zentrum fuer Onkologie und Urologie Rostock
Rostock, Germany, 18107
Site DE49014 Private Practice
Sangerhausen, Germany, 6526
Greece
Site GR30009 Aretaieio/Maginio
Athens, Greece, 115 28
Hong Kong
Site HK85204 The Chinese Uni of HK, Prince of Wales Hospital
Hong Kong, Hong Kong
Site HK85201 Kwong Wah Hospital
Kowloon, Hong Kong
Site HK85203 The Chinese Uni of HK, Prince of Wales Hospital
Shatin, Hong Kong, 30-32
Hungary
Site HU36003 Dr.Szarka Ödön Kistérségi Egészségügyi Szolgáltató Kft
Csongrád, Hungary, 6640
Site HU36007 Mediroyal Prevention Center
Kecskemet, Hungary, 6000
Site HU36005 Uro-clin Ltd
Pecs, Hungary, 7621
Site HU36013 Sopron Erzsébet Hospital
Sopron, Hungary, H-9400
Site HU36001 Donatella 99BT
Szentes, Hungary, 6600
Site HU36012 Veszprém County Cholnoky Ferenc Hospital
Veszprém, Hungary, 8200
Italy
Site IT39022 Azienda Ospedale Umberto I (Ancona)
Ancona, Italy, 60126
Site IT39007 Azienda Ospedaliera San Giuseppe Moscati
Avellino, Italy, 83100
Site IT39001 U.O. Dip. di Neuro-Urologia; Univ. di Roma La Sapienza
Latina, Italy, 4100
Site IT39020 Ospedale San Raffaele IRCCS, U.O. di Ginecologia e Ostetricia, Unità Funzionale di Uroginecologia
Milano, Italy, 20132
Site IT39003 Ospedale San Raffaele
Milan, Italy, 20132
Korea, Republic of
Site KR82014 Soon Chun Hyang University Hospital
Bucheon-Si, Korea, Republic of, 420-767
Site KR82006 Dong-A University Medical Center
Busan, Korea, Republic of, 602-715
Site KR82016 Pusan National University Hospital
Busan, Korea, Republic of, 602-739
Site KR82024 Chungbuk National University Hospital
Cheongju-si, Korea, Republic of, 361-711
Site KR82032 Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-421
Site KR82005 Yeungnam University Hospital
Daegu, Korea, Republic of, 705-717
Site KR82029 Daegu Catholic Univ. Medical Center
Daegu, Korea, Republic of, 705-718
Site KR82019 Chungnam National University Hospital
Daejeon, Korea, Republic of, 301-721
Site KR82011 Eulji University Hospital
Daejeon, Korea, Republic of, 302-799
Site KR82031 Chonnam National University Hospital
Gwangju, Korea, Republic of, 501757
Site KR82009 Wonkwang University Hospital
Iksan -Si, Korea, Republic of, 570-711
Site KR82023 Gachon University Gil Hospital
Incheon, Korea, Republic of, 405760
Site KR82010 Chonbuk National University Hospital
Jeonju-si, Korea, Republic of, 561-712
Site KR82025 Seoul National University Bundang Hospital
Seongnam-si, Korea, Republic of, 463-707
Site KR82021 Cheil General Hospital & Women's Healthcare Center
Seoul, Korea, Republic of, 100-380
Site KR82020 Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Site KR82030 Severance Hospital
Seoul, Korea, Republic of, 120-752
Site KR82013 Hallym University Kangdong Sacred Heart Hospital
Seoul, Korea, Republic of, 134-701
Site KR82017 Kyung Hee University Medical Center
Seoul, Korea, Republic of, 134-872
Site KR82002 Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Site KR82008 Gangnam Severance Hospital
Seoul, Korea, Republic of, 135-720
Site KR82015 Korea University Medical Center
Seoul, Korea, Republic of, 136-075
Site KR82001 Seoul Saint Mary's Hospital
Seoul, Korea, Republic of, 137-040
Site KR82003 Asan Medical Center
Seoul, Korea, Republic of, 138-736
Site KR82012 Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
Site KR82004 Ajou University Hospital
Suwon-si, Korea, Republic of, 443-721
Latvia
Site LV37102 Private Practice
Liepaja, Latvia, LV-3401
Site LV37103 Health Centre "Olaine"
Olaine, Latvia, LV-2114
Site LV37105 P.Stradins Clinical University Hospital
Riga, Latvia, 1002
Lithuania
Site LT37008 Kaunas 2nd Clinical Hospital
Kaunas, Lithuania, 47144
Site LT37004 KHospital of Lithuanian University of Health Science
Kaunas, Lithuania, 50009
Site LT37011 Saules Family Medicine Centre
Kaunas, Lithuania
Site LT37012 Klaipeda University Hospital
Klaipeda, Lithuania, LT-92288
Site LT37005 Public Institution Vilnius City University Hospital
Vilnius, Lithuania, 10207
Site LT37010 Public Institution Vilnius City University Hospital
Vilnius, Lithuania, 10207
Site LT37003 Family Medical Centre Seimos gydytojas
Vilnius, Lithuania, LT-01118
Site LT37007 Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania, LT-08661
Site LT37009 Clinics Privatus gydytojas
Vilnius, Lithuania, LT-09108
Malaysia
Site MY60006 Hospital Pulau Pinang
Georgetown, Malaysia, 10990
Site MY60001 Hospital Kuala Lumpur
Kuala Lumpur, Malaysia, 50586
Site MY60004 University Malaya Medical Centre
Kuala Lumpur, Malaysia, 50603
Site MY60005 Universiti Kebangsaan Malaysia Medical Centre
Kuala Lumpur, Malaysia, 56000
Site MY60003 Hospital Ummum Sarawak
Kuching, Malaysia, 93586
Site MY60002 Sime Darby Medical Centre
Petaling Jaya, Malaysia, 47500
Mexico
Site MX52004 Consultorio de Especialidad en Urologia
Durango, Mexico, 34000
Site MX52001 Centro de Investigacin Basica y Clnica
Guadalajara, Mexico, 45040
Site MX52003 Clinstile, Sociedad Anonima de Capital Variable
Mexico City, Mexico, 6700
Site MX52002 Accelerium Clinical Research/ Hospital San Jorge
Monterrey, Mexico, 64000
Netherlands
Site NL31002 Academic Medical Center (AMC)
Amsterdam, Netherlands, 1105 AZ
Site NL31006 Medisch Spectrum Twente
Enschede, Netherlands, 7513ER
Site NL31005 Canisius-Wilhelmina Ziekenhuis
Nijmegen, Netherlands, 6532 SZ
Site NL31010 Antonius Ziekenhuis Sneek
Sneek, Netherlands, 8601 ZK
Site NL31001 University Medical Centre Utrecht
Utrecht, Netherlands, 3584 CX
New Zealand
Site NZ64004 John A Tuckey Ltd Ascot Central
Auckland, New Zealand, 1541
Site NZ64001 Canterbury Urology Research Trust
Christchurch, New Zealand, 8014
Site NZ64005 Waikato Urology Research Limited
Hamilton, New Zealand, 3204
Site NZ64002 Roundhay Medical Centre
Nelson, New Zealand, 7010
Site NZ64003 Tauranga Urology Research Ltd
Tauranga, New Zealand, 3140
Site NZ64006 Cardinal Point Specialist Centre
Whangarei, New Zealand
Norway
Site NO47006 M3 Helse AS
Hamar, Norway, 2317
Site NO47008 Norsk Helseklinikk (Heiaklinikken)
Lierskogen, Norway, 3420
Site NO47007 Medi3 Clinic AS, Ålesund
Ålesund, Norway, 6003
Peru
Site PE51006 Hospital Nacional Guillermo Almenara Irigoyen EsSalud
La Victoria, Lima, Peru, 13
Site PE51007 Clínica Anglo Americana
San Isidro, Lima, Peru, 27
Site PE51001 Instituto de Ginecologia y Reproduccion
Lima, Peru, 33
Site PE51002 Clinica San Borja
Lima, Peru, 41
Site PE51004 Clinica San Pablo
Lima, Peru
Site PE51005 Hospital Nacional Hipolito Unanue
Lima, Peru
Philippines
Site PH63008 Dr. Pablo O. Torre Memorial Hospital
Bacolod City, Philippines, 6100
Site PH63005 Davao Doctor's Hospital
Davao City, Philippines, 8000
Site PH63010 Davao Doctor's Hospital
Davao City, Philippines, 8000
Site PH63003 University of Santo Tomas Hospital (USTH)
Manila, Philippines, 1008
Site PH63009 Chinese General Hospital and Medical Center
Manila, Philippines, 1008
Site PH63004 East Avenue Medical Center
Quezon City, Philippines, 1101
Poland
Site PL48018 Gastromed
Bialystok, Poland, 15-351
Site PL48013 Urovita Ltd.
Chorzow, Poland, 41-500
Site PL48014 Synexus Polska
Gdynia, Poland, 81-384
Site PL48004 NZOZ Szpital Sw.Rodziny Centrum Medyczne
Lodz, Poland, 90-302
Site PL48010 Nzoz Novita
Lublin, Poland, 20-632
Site PL48011 Nzoz Centrum Urologiczne sp. z o.o.
Myslowice, Poland, 41-400
Site PL48016 Prywatny Gabinet Urologiczny
Opole, Poland, 45-086
Site PL48005 HEUREKA Hanna Szalecka
Piaseczno, Poland, 05-500
Site PL48012 Military Institute of Medicine
Warsaw, Poland, 00-909
Site PL48003 CSKMSW
Warsaw, Poland, 02-507
Site PL48001 Specjalistyczny Gabinet Lekarski
Warszawa, Poland, 02-929
Site PL48019 Synexus Polska sp. z o. o.
Wrocław, Poland, 50-088
Romania
Site RO40015 Spitaul Clinic Judetean de Urgenta Brasov
Brasov, Romania, 500152
Site RO40004 Spitalul Clinic de Urgenta Sfantul Ioan
Bucuresti, Romania, 42122
Site RO40001 Spiatlul Clinic Th. Burghele
Bucuresti, Romania, 50659
Site RO40005 Spiatlul Clinic Th. Burghele
Bucuresti, Romania, 50659
Site RO40014 E-URO Cabinet
Cluj-Napoca, Romania, 400046
Site RO40007 Spital Clinic
Iasi, Romania, 700503
Site RO40010 Spitalul Clinic Judetan de Urgenta Sibiu
Sibiu, Romania, 550245
Site RO40002 Spitalul Clinic Judetean de Urgenta Timisoara
Timisoara, Romania, 300736
Russian Federation
Site RU70015 LLC Clinical Research Medical Complex
Kazan, Russian Federation, 420097
Site RU70023 Penza Regional Clinical Hospatal n. a. N.N. Burdenko
Penza, Russian Federation, 440026
Site RU70019 City Multidisciplinary Hospital No. 2
Saint Petersburg, Russian Federation, 194354
Site RU70002 Pavlov St. Petersburg State Medical University
Saint Petersburg, Russian Federation, 197089
Site RU70022 St. Petersburg State Public Health Institution
Saint Petersburg, Russian Federation, 198103
Site RU70014 OOO Hospital Orkli
St. Petersburg, Russian Federation, 199178
Site RU70018 Bashkirsky State Medical University of Roszdrav
Ufa, Russian Federation, 450096
Singapore
Site SG65001 National University Hospital
Singapore, Singapore, 119074
Site SG65002 Singapore General Hospital
Singapore, Singapore, 169608
Site SG65003 KK Women's and Children's Hospital
Singapore, Singapore, 229899
Slovakia
Site SK42105 Ruzinovska poliklinika a.s.
Bratislava, Slovakia, 82101
Site SK42107 Zeleznicne zdravotnictvo Kosice, s.r.o.
Kosice, Slovakia, 4001
Site SK42101 Andrologicka a Urologicka Ambulancia
Kosice, Slovakia, 4013
Site SK42103 UroExam s.r.o.
Nitra, Slovakia, 949 01
Site SK42108 BrenCare, s. r. o.
Poprad, Slovakia, 058 01
Site SK42104 Urology Outpatient Department
Presov, Slovakia, 8001
Site SK42106 Private Urological Care Center
Trencin, Slovakia, 911 01
Site SK42102 CeGys, s.r.o.
Trencin, Slovakia, 91101
Slovenia
Site SI38604 General Hospital Murska Sobota
Murska Sobota, Slovenia, 9000
Site SI38602 General Hospital Novo Mesto
Novo Mesto, Slovenia, 8000
South Africa
Site ZA27005 Grootte Schuur Hospital
Cape Town, South Africa, 7925
Site ZA27001 Private Practice
Centurion, South Africa, 0157
Site ZA27006 Parklands Hospital
Durban, South Africa, 4001
Site ZA27013 Synexus Clinical Research SA (Pty) Ltd
Meyerspark, South Africa, 184
Site ZA27007 Paarl Medical Centre
Paarl, South Africa, 7646
Site ZA27002 Mayo Clinic
Roodepoort, South Africa, 1709
Spain
Site ES34010 Hospital del Henares
Coslada, Spain, 28822
Site ES34024 Hospital San Juan de Dios
Esplugues De Llobregat-Barcelo, Spain, 08950
Site ES34001 Hospital Universitario de Getafe
Getafe (Madrid), Spain, 28905
Site ES34006 Hospital San Rafael
Madrid, Spain, 28016
Site ES34004 Hospital Infanta Leonor
Madrid, Spain, 28031
Site ES34015 Hospital 12 de Octubre
Madrid, Spain, 28044
Site ES34009 Hospital Universitario La Paz
Madrid, Spain, 28046
Site ES34005 Hospital de Fuenlabrada
Madrid, Spain, 28942
Site ES34003 Hospital Universitario Nuestra Señora de Valme
Sevilla, Spain, 41001
Site ES34007 Hospital Virgen del Rocio
Sevilla, Spain, 41013
Site ES34002 H. U. Politecnico La Fe
Valencia, Spain, 46026
Sweden
Site SE46007 Ladulaas Clinical Studies
Boras, Sweden, 506 30
Site SE46025 Pharmasite
Helsingborg, Sweden, 252 20
Site SE46005 Center för Läkemedelsstudier
Malmö, Sweden, 211 52
Site SE46016 Citydiabetes - Stockholm
Stockholm, Sweden, 111 57
Site SE46008 Bragée Medect AB
Stockholm, Sweden, 115 22
Site SE46012 Karolinska University Hospital Huddinge
Stockholm, Sweden, 141 86
Site SE46003 Danderyds Hospital
Stockholm, Sweden, 182 88
Site SE46009 Encia AB, Uppsala Hälsomottagning
Uppsala, Sweden, 753 35
Site SE46017 S3 Clinical Research Centers
Vällingby, Sweden, 162 68
Taiwan
Site TW88605 Taichung Veteran General Hospital
Taichung, Taiwan, 40705
Site TW88611 Chung Shan Medical University Hospital
Taichung, Taiwan, 407
Site TW88612 Chi Mei Medical Center, Yong Kang
Tainan, Taiwan, 710
Site TW88614 Tri-Service General Hospital
Taipei, Taiwan, 114
Thailand
Site TH66002 Chulalongkorn Hospital
Bangkok, Thailand, 10330
Site TH66008 Phramongkutklao Hospital
Bangkok, Thailand, 10400
Site TH66005 Siriraj Hospital
Bangkok, Thailand, 10700
Site TH66010 Maharaj Nakorm Chiangmai Hosp
Chiang Mai, Thailand, 50200
Site TH66006 Songklanagarind Hospital, Prince of Songkla University
Hat Yai, Thailand, 90110
Site TH66009 Srinagarind Hospital
Khon Kaen, Thailand, 40002
Site TH66007 Thammasat University Hospital
Pathum Thani, Thailand, 12120
Site TH66011 Ramathibodi Hospital
Ratchathewi, Thailand, 10400
Turkey
Site TR90019 Ankara University Medical Faculty Ibni Sina Hospital
Ankara, Turkey, 06100
Site TR90013 Uludag University Faculty of Medicine
Bursa, Turkey, 16059
Site TR90001 Pamukkale University Faculty of Medicine
Denizli, Turkey, 20070
Site TR90017 Bilim University Sisli Florence Nightingale Hospital
Istanbul, Turkey, 34381
Ukraine
Site UA38002 City Hospital No 2
Chernigov, Ukraine, 14034
Site UA38015 Regional Municipal Institution, Urology Department
Chernivtsi, Ukraine, 58000
Site UA38013 Dnipropetrovsk State Medical Academy, Mechnikov Dnipropetrov
Dnipropetrovsk, Ukraine, 49005
Site UA38006 Shapoval Regional Clinical Centre of Urology and Nephrology
Kharkiv, Ukraine, 61037
Site UA38007 Central Outpatient Hospital of Deanyanskyy Distric
Kiev, Ukraine, 02232
Site UA38003 Urology Dpt of Kyiv City Clinical Hospital #3
Kyiv, Ukraine, 02660
Site UA38010 Academy of Medical Sciences of Ukraine
Kyiv, Ukraine, 04053
Site UA38014 Uzhgorod City Polyclinic
Uzhorod, Ukraine, 88000
Site UA38004 Vinnitsa Endocrinology Dispens
Vinnytsya, Ukraine, 21010
Site UA38008 Medical Academy of Postgraduate Education, Urology Clinic
Zaporizhzhya, Ukraine, 69600
United Kingdom
Site GB44009 Sheepcot Medical Centre
Garston, Watfort, United Kingdom, WD25 0EA
Site GB44003 Leighton Hospital
Crewe, United Kingdom, CW1 4QJ
Site GB44021 Medway Hospital
Gillingham, United Kingdom, ME7 5WY
Site GB44005 North West London Hosp Menopause Clinic
Harrow, United Kingdom, HA1 3UJ
Site GB44024 St James's University Hospital
Leeds, United Kingdom, LS7 9TF
Site GB44025 Kings College Hospital
London, United Kingdom, SE5 9RS
Site GB44006 Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Site GB44022 The Royal Berkshire Hospital
Reading, United Kingdom, RG1 5AN
Site GB44001 Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
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:
Layout table for additonal information
Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT01972841     History of Changes
Other Study ID Numbers: 178-CL-101
2012-005735-91 ( EudraCT Number )
U1111-1153-9095 ( Other Identifier: World Health Organization )
First Posted: October 31, 2013    Key Record Dates
Results First Posted: June 12, 2018
Last Update Posted: November 1, 2018
Last Verified: October 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. ):
Combination Therapy
Mirabegron
Overactive Bladder
Urgency
Urinary Incontinence
Nocturia
Solifenacin Succinate
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