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

Phase 3

Completed

Conditions: Urinary Bladder Overactive
Urinary Bladder Diseases\Urologic Diseases
Overactive Bladder
Urgency Incontinence

Interventions: Drug: Placebo to match solifenacin succinate
Drug: Mirabegron
Drug: Solifenacin succinate
Drug: Placebo to match mirabegron

Registration Number: NCT01972841

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3527

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2: Solifenacin 5 mg + Mirabegron 50 mg	Placebo to match mirabegron	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
3: Placebo	Placebo to match solifenacin succinate	Participants who received matching placebo once a day for 12 weeks.
5:Mirabegron 25 mg	Mirabegron	Participants who received mirabegron 25 mg once a day for 12 weeks.
5:Mirabegron 25 mg	Placebo to match solifenacin succinate	Participants who received mirabegron 25 mg once a day for 12 weeks.
5:Mirabegron 25 mg	Placebo to match mirabegron	Participants who received mirabegron 25 mg once a day for 12 weeks.
6: Mirabegron 50 mg	Mirabegron	Participants who received mirabegron 50 mg once a day for 12 weeks.
6: Mirabegron 50 mg	Placebo to match solifenacin succinate	Participants who received mirabegron 50 mg once a day for 12 weeks.
1: Solifenacin 5 mg + Mirabegron 25 mg	Placebo to match mirabegron	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.
6: Mirabegron 50 mg	Placebo to match mirabegron	Participants who received mirabegron 50 mg once a day for 12 weeks.
3: Placebo	Placebo to match mirabegron	Participants who received matching placebo once a day for 12 weeks.
4: Solifenacin 5 mg	Placebo to match mirabegron	Participants who received solifenacin 5 mg once a day for 12 weeks.
1: Solifenacin 5 mg + Mirabegron 25 mg	Mirabegron	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.
1: Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin succinate	Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.
2: Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin succinate	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
2: Solifenacin 5 mg + Mirabegron 50 mg	Mirabegron	Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
4: Solifenacin 5 mg	Solifenacin succinate	Participants who received solifenacin 5 mg once a day for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours	Baseline and 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.
Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours	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

Name	Time	Method
Change From Baseline to EoT in Mean Volume Voided Per Micturition	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.
Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score	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.
Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)	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.
Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	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.
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Baseline and weeks 4, 8 and 12
Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Baseline and weeks 4, 8 and 12
Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Baseline and weeks 4, 8 and 12
Change From Baseline to EoT in Corrected Micturition Frequency	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.
Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	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.
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	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.
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	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.
Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	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.
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks)
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	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.
Number of Pads Used at Weeks 4, 8, 12 and EoT	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.
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks)
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	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.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	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.
Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	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).
PGIC Scale: Impression in General Health at Week 12 and EoT	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).
Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	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.
Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	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.
Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	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.
Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	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.
Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	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.
Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	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).
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	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.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	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.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	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.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	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.
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	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).
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	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).
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment	Baseline and week 12 and EoT (up to 12 weeks)
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	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).
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	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).
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	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.
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	Baseline and week 12 and EoT (up to 12 weeks)
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment	Baseline and week 12 and EoT (up to 12 weeks)
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	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.
Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	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.
Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	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).
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	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).
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	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.
Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	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).
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	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.
Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	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.
Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	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.
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	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.
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	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.
Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	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.
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	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.
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	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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 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.
Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)	PVR volume was assessed by ultrasonography or a bladder scanner.
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	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.
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	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.
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	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.
Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	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.
Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	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.
Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	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.
Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	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.
Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	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.
Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	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.
Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	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.
Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	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.
Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	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.

Trial Locations

Locations (435): Site DE49034 LMU Muenchen
🇩🇪
Munich, Germany
Site DE49001 Private Practice
🇩🇪
Neustadt I. Sachsen, Germany
Site US10064 The Group for Women
🇺🇸
Virginia Beach, Virginia, United States
Site US10539 Citrus Valley Medical Research
🇺🇸
Glendora, California, United States
Site US10122 Orange County Research Institute
🇺🇸
Anaheim, California, United States
Site US10018 Grove Hill Clinical Research
🇺🇸
New Britain, Connecticut, United States
Site US10150 Suncoast Clinical Research, Inc.
🇺🇸
New Port Richey, Florida, United States
Site US10158 Renstar Medical Research
🇺🇸
Ocala, Florida, United States
Site US10123 Chase Medical Research, LLC
🇺🇸
Waterbury, Connecticut, United States
Site US10149 Bayview Research Group
🇺🇸
Paramount, California, United States
Site US10091 Health Awareness
🇺🇸
Jupiter, Florida, United States
Site US10128 Clinical Research Center of CT
🇺🇸
Danbury, Connecticut, United States
Site US10165 East Coast Institute for Research
🇺🇸
Jacksonville, Florida, United States
Site US10148 Best Quality Research, Inc.
🇺🇸
Hialeah, Florida, United States
Site US10098 Skyline Research
🇺🇸
Cerritos, California, United States
Site US10595 Bayview Research Group
🇺🇸
Valley Village, California, United States
Site US10097 A.G.A. Clinical Trials DBA Neostart Group
🇺🇸
Hialeah, Florida, United States
Site US10536 Stanford School of Medicine
🇺🇸
Palo Alto, California, United States
Site US10088 Centex Studies, Inc.
🇺🇸
Lake Charles, Louisiana, United States
Site US10542 Adult & Pediatric Urology Group
🇺🇸
Sartell, Minnesota, United States
Site US10534 South Florida Medical Research
🇺🇸
Hialeah, Florida, United States
Site US10025 Regional Urology, LLC
🇺🇸
Shreveport, Louisiana, United States
Site US10060 Meridien Research
🇺🇸
Bradenton, Florida, United States
Site US10009 South Broward Research
🇺🇸
Pembroke Pines, Florida, United States
Site US10106 West Coast Clinical Research
🇺🇸
Tarzana, California, United States
Site US10127 Perimeter North Medical Research, Inc.
🇺🇸
Roswell, Georgia, United States
Site US10078 Heartland Research Associates, LLC
🇺🇸
Wichita, Kansas, United States
Site US10120 WR-Mount Vernon Clinical Research
🇺🇸
Sandy Springs, Georgia, United States
Site US10024 GTC Research
🇺🇸
Shawnee Mission, Kansas, United States
Site US10553 Women's Clinic of Lincoln
🇺🇸
Lincoln, Nebraska, United States
Site US10114 Bay State Clinical Trials, Inc.
🇺🇸
Watertown, Massachusetts, United States
Site US10154 Montana Medical Research Inc
🇺🇸
Missoula, Montana, United States
Site BE32012 Sint-Trudo Ziekenhuis, Campus Sint Jozef/Sint-Anna
🇧🇪
Sint-Truiden, Belgium
Site AU61019 AusTrialsSherwood
🇦🇺
Sherwood, Australia
Site BG35908 MHAT Plovdiv AD
🇧🇬
Plovdiv, Bulgaria
Site BE32004 Gent University Hospital
🇧🇪
Gent, Belgium
Site CA15006 Bramalea Medical Centre
🇨🇦
Brampton, Ontario, Canada
Site CA15033 Prohealth
🇨🇦
Vancouver, British Columbia, Canada
Site AU61004 Keogh Institute for Medical Research
🇦🇺
Perth, Australia
Site CA15044 McMaster Institute of Urology
🇨🇦
Hamilton, Ontario, Canada
Site AU61008 Epworth Healthcare
🇦🇺
Richmond, Australia
Site BE32011 Universitaire Ziekenhuizen Leuven
🇧🇪
Leuven, Belgium
Site BG35906 UMHAT Varna
🇧🇬
Varna, Bulgaria
Site CA15001 The Male/Female Health & Research Centre
🇨🇦
Barrie, Ontario, Canada
Site BE32014 Hart Ziekenhuis
🇧🇪
Roeselare, Belgium
Site AU61017 Healthpac Medical Centre
🇦🇺
Sydney, Australia
Site BG35904 University Hospital (UMHAT) - George Stranski
🇧🇬
Pleven, Bulgaria
Site CA15040 RechercheGCP Research
🇨🇦
Montreal, Quebec, Canada
Site CA15039 Pro-recherche
🇨🇦
St-Romuald, Quebec, Canada
Site CZ42011 Hospital Novy Jicin
🇨🇿
Novy Jicin, Czechia
Site CZ42010 G-centrum Olomouc S.R.O.
🇨🇿
Olomouc, Czechia
Site BG35902 MHAT Ruse
🇧🇬
Ruse, Bulgaria
Site BG35910 MHAT
🇧🇬
Veliko Tarnovo, Bulgaria
Site AU61011 Illawarra Health and Medical Research Institute
🇦🇺
Wollongong, Australia
Site US10004 Integrity Medical Research, LLC
🇺🇸
Mountlake Terrace, Washington, United States
Site AU61021 Royal Hospital for Women
🇦🇺
Sydney, Australia
Site CA15003 Brantford Urology Research
🇨🇦
Brantford, Ontario, Canada
Site CA15007 Eunoia2 Incorporated
🇨🇦
Kitchener, Ontario, Canada
Site CA15021 Urology South Shore Research
🇨🇦
Greenfield Park, Quebec, Canada
Site CA15004 Primehealth Clinical Research
🇨🇦
Toronto, Ontario, Canada
Site BG35905 MHAT Alexandrovska Hospital
🇧🇬
Sofia, Bulgaria
Site CA15010 Ultra Med Research, Inc.
🇨🇦
Point-Claire, Quebec, Canada
Site CA15015 Recherches Cliniques Theradev, Inc.
🇨🇦
Granby, Quebec, Canada
Site AU61022 Brisbane South Clinical Research Centre
🇦🇺
Brisbane, Australia
Site DE49003 Private Practice
🇩🇪
Lutherstadt Eisleben, Germany
Site CA15032 Stanley Flax Medical Prof Corp
🇨🇦
North York, Ontario, Canada
Site CN86017 Affiliated Union Hospital of Fujian Medical Uni.
🇨🇳
Fuzhou, Fujian, China
Site CA15034 Oxford/Richmond Medical
🇨🇦
London, Ontario, Canada
Site CZ42006 Private Practice
🇨🇿
Usti nad Labem, Czechia
Site BG35903 MHATEM Pirogov
🇧🇬
Sofia, Bulgaria
Site CA15002 Toronto Western Hospital
🇨🇦
Toronto, Ontario, Canada
Site CA15026 Rhodin Recherche Clinique
🇨🇦
Drummondville, Quebec, Canada
Site CZ42002 Hospital Jihlava
🇨🇿
Jihlava, Czechia
Site CZ42001 Fakultni Nemocnice Hradec Kralove
🇨🇿
Hradec Kralove, Czechia
Site PL48005 HEUREKA Hanna Szalecka
🇵🇱
Piaseczno, Poland
Site CN86029 Southwest Hospital (Chongqing)
🇨🇳
Chongqing, China
Site CN86013 Beijing Hospital
🇨🇳
Beijing, China
Site FR33002 CHU Carémeau
🇫🇷
Nimes Cedex, France
Site CZ42005 Research Site s.r.o.
🇨🇿
Plzen, Czechia
Site CZ42014 Private Practice
🇨🇿
Ostrava, Czechia
Site EE37205 West Tallinn Central Hospital
🇪🇪
Tallinn, Estonia
Site EE37202 Tartu University Hospital
🇪🇪
Tartu, Estonia
Site LT37005 Public Institution Vilnius City University Hospital
🇱🇹
Vilnius, Lithuania
Site MY60001 Hospital Kuala Lumpur
🇲🇾
Kuala Lumpur, Malaysia
Site HU36003 Dr.Szarka Ödön Kistérségi Egészségügyi Szolgáltató Kft
🇭🇺
Csongrád, Hungary
Site MY60004 University Malaya Medical Centre
🇲🇾
Kuala Lumpur, Malaysia
Site MY60003 Hospital Ummum Sarawak
🇲🇾
Kuching, Malaysia
Site MX52004 Consultorio de Especialidad en Urologia
🇲🇽
Durango, Mexico
Site NL31010 Antonius Ziekenhuis Sneek
🇳🇱
Sneek, Netherlands
Site NZ64006 Cardinal Point Specialist Centre
🇳🇿
Whangarei, New Zealand
Site NO47006 M3 Helse AS
🇳🇴
Hamar, Norway
Site HU36005 Uro-clin Ltd
🇭🇺
Pecs, Hungary
Site NL31006 Medisch Spectrum Twente
🇳🇱
Enschede, Netherlands
Site KR82009 Wonkwang University Hospital
🇰🇷
Iksan -Si, Korea, Republic of
Site LT37009 Clinics Privatus gydytojas
🇱🇹
Vilnius, Lithuania
Site MY60005 Universiti Kebangsaan Malaysia Medical Centre
🇲🇾
Kuala Lumpur, Malaysia
Site PL48013 Urovita Ltd.
🇵🇱
Chorzow, Poland
Site PL48004 NZOZ Szpital Sw.Rodziny Centrum Medyczne
🇵🇱
Lodz, Poland
Site IT39022 Azienda Ospedale Umberto I (Ancona)
🇮🇹
Ancona, Italy
Site NZ64001 Canterbury Urology Research Trust
🇳🇿
Christchurch, New Zealand
Site HU36013 Sopron Erzsébet Hospital
🇭🇺
Sopron, Hungary
Site LT37011 Saules Family Medicine Centre
🇱🇹
Kaunas, Lithuania
Site LT37003 Family Medical Centre Seimos gydytojas
🇱🇹
Vilnius, Lithuania
Site PH63003 University of Santo Tomas Hospital (USTH)
🇵🇭
Manila, Philippines
Site RO40015 Spitaul Clinic Judetean de Urgenta Brasov
🇷🇴
Brasov, Romania
Site PL48010 Nzoz Novita
🇵🇱
Lublin, Poland
Site RU70019 City Multidisciplinary Hospital No. 2
🇷🇺
Saint Petersburg, Russian Federation
Site NZ64004 John A Tuckey Ltd Ascot Central
🇳🇿
Auckland, New Zealand
Site RU70018 Bashkirsky State Medical University of Roszdrav
🇷🇺
Ufa, Russian Federation
Site RU70023 Penza Regional Clinical Hospatal n. a. N.N. Burdenko
🇷🇺
Penza, Russian Federation
Site KR82012 Konkuk University Medical Center
🇰🇷
Seoul, Korea, Republic of
Site LV37103 Health Centre "Olaine"
🇱🇻
Olaine, Latvia
Site LT37004 KHospital of Lithuanian University of Health Science
🇱🇹
Kaunas, Lithuania
Site NZ64002 Roundhay Medical Centre
🇳🇿
Nelson, New Zealand
Site LT37012 Klaipeda University Hospital
🇱🇹
Klaipeda, Lithuania
Site PL48012 Military Institute of Medicine
🇵🇱
Warsaw, Poland
Site PL48001 Specjalistyczny Gabinet Lekarski
🇵🇱
Warszawa, Poland
Site NO47008 Norsk Helseklinikk (Heiaklinikken)
🇳🇴
Lierskogen, Norway
Site PE51006 Hospital Nacional Guillermo Almenara Irigoyen EsSalud
🇵🇪
La Victoria, Lima, Peru
Site PE51004 Clinica San Pablo
🇵🇪
Lima, Peru
Site PL48018 Gastromed
🇵🇱
Bialystok, Poland
Site PL48014 Synexus Polska
🇵🇱
Gdynia, Poland
Site PL48011 Nzoz Centrum Urologiczne sp. z o.o.
🇵🇱
Myslowice, Poland
Site PE51007 Clínica Anglo Americana
🇵🇪
San Isidro, Lima, Peru
Site PL48016 Prywatny Gabinet Urologiczny
🇵🇱
Opole, Poland
Site PL48003 CSKMSW
🇵🇱
Warsaw, Poland
Site NZ64005 Waikato Urology Research Limited
🇳🇿
Hamilton, New Zealand
Site PL48019 Synexus Polska sp. z o. o.
🇵🇱
Wrocław, Poland
Site RU70014 OOO Hospital Orkli
🇷🇺
St. Petersburg, Russian Federation
Site NZ64003 Tauranga Urology Research Ltd
🇳🇿
Tauranga, New Zealand
Site RU70015 LLC Clinical Research Medical Complex
🇷🇺
Kazan, Russian Federation
Site SK42103 UroExam s.r.o.
🇸🇰
Nitra, Slovakia
Site SK42106 Private Urological Care Center
🇸🇰
Trencin, Slovakia
Site TW88605 Taichung Veteran General Hospital
🇨🇳
Taichung, Taiwan
Site UA38014 Uzhgorod City Polyclinic
🇺🇦
Uzhorod, Ukraine
Site GB44005 North West London Hosp Menopause Clinic
🇬🇧
Harrow, United Kingdom
Site UA38006 Shapoval Regional Clinical Centre of Urology and Nephrology
🇺🇦
Kharkiv, Ukraine
Site UA38004 Vinnitsa Endocrinology Dispens
🇺🇦
Vinnytsya, Ukraine
Site ES34004 Hospital Infanta Leonor
🇪🇸
Madrid, Spain
Site RU70022 St. Petersburg State Public Health Institution
🇷🇺
Saint Petersburg, Russian Federation
Site ES34015 Hospital 12 de Octubre
🇪🇸
Madrid, Spain
Site TW88612 Chi Mei Medical Center, Yong Kang
🇨🇳
Tainan, Taiwan
Site ZA27005 Grootte Schuur Hospital
🇿🇦
Cape Town, South Africa
Site GB44025 Kings College Hospital
🇬🇧
London, United Kingdom
Site SK42105 Ruzinovska poliklinika a.s.
🇸🇰
Bratislava, Slovakia
Site UA38015 Regional Municipal Institution, Urology Department
🇺🇦
Chernivtsi, Ukraine
Site UA38008 Medical Academy of Postgraduate Education, Urology Clinic
🇺🇦
Zaporizhzhya, Ukraine
Site SE46003 Danderyds Hospital
🇸🇪
Stockholm, Sweden
Site SE46009 Encia AB, Uppsala Hälsomottagning
🇸🇪
Uppsala, Sweden
Site ES34009 Hospital Universitario La Paz
🇪🇸
Madrid, Spain
Site ES34003 Hospital Universitario Nuestra Señora de Valme
🇪🇸
Sevilla, Spain
Site SK42108 BrenCare, s. r. o.
🇸🇰
Poprad, Slovakia
Site SE46007 Ladulaas Clinical Studies
🇸🇪
Boras, Sweden
Site SK42102 CeGys, s.r.o.
🇸🇰
Trencin, Slovakia
Site TH66009 Srinagarind Hospital
🇹🇭
Khon Kaen, Thailand
Site UA38003 Urology Dpt of Kyiv City Clinical Hospital #3
🇺🇦
Kyiv, Ukraine
Site TR90019 Ankara University Medical Faculty Ibni Sina Hospital
🇹🇷
Ankara, Turkey
Site SE46017 S3 Clinical Research Centers
🇸🇪
Vällingby, Sweden
Site TR90017 Bilim University Sisli Florence Nightingale Hospital
🇹🇷
Istanbul, Turkey
Site ES34002 H. U. Politecnico La Fe
🇪🇸
Valencia, Spain
Site TH66010 Maharaj Nakorm Chiangmai Hosp
🇹🇭
Chiang Mai, Thailand
Site UA38002 City Hospital No 2
🇺🇦
Chernigov, Ukraine
Site UA38013 Dnipropetrovsk State Medical Academy, Mechnikov Dnipropetrov
🇺🇦
Dnipropetrovsk, Ukraine
Site UA38010 Academy of Medical Sciences of Ukraine
🇺🇦
Kyiv, Ukraine
Site ZA27001 Private Practice
🇿🇦
Centurion, South Africa
Site ZA27002 Mayo Clinic
🇿🇦
Roodepoort, South Africa
Site ES34001 Hospital Universitario de Getafe
🇪🇸
Getafe (Madrid), Spain
Site ES34007 Hospital Virgen del Rocio
🇪🇸
Sevilla, Spain
Site GB44009 Sheepcot Medical Centre
🇬🇧
Garston, Watfort, United Kingdom
Site ES34006 Hospital San Rafael
🇪🇸
Madrid, Spain
Site ES34024 Hospital San Juan de Dios
🇪🇸
Esplugues De Llobregat-Barcelo, Spain
Site TH66008 Phramongkutklao Hospital
🇹🇭
Bangkok, Thailand
Site TH66007 Thammasat University Hospital
🇹🇭
Pathum Thani, Thailand
Site SE46016 Citydiabetes - Stockholm
🇸🇪
Stockholm, Sweden
Site TW88614 Tri-Service General Hospital
🇨🇳
Taipei, Taiwan
Site GB44006 Derriford Hospital
🇬🇧
Plymouth, United Kingdom
Site GB44021 Medway Hospital
🇬🇧
Gillingham, United Kingdom
Site GB44001 Royal Hallamshire Hospital
🇬🇧
Sheffield, United Kingdom
Site US10132 Axis Clinical Trials
🇺🇸
Los Angeles, California, United States
Site US10133 Axis Clinical Trials
🇺🇸
Los Angeles, California, United States
Site US10050 Rapid Medical Research, Inc.
🇺🇸
Cleveland, Ohio, United States
Site US10250 Preferred Primary Care Physicians Inc.
🇺🇸
Pittsburgh, Pennsylvania, United States
Site US10248 Preferred Primary Care Physicians, Inc
🇺🇸
Pittsburgh, Pennsylvania, United States
Site US10282 Boston Clinical Trials
🇺🇸
Boston, Massachusetts, United States
Site US10558 Chesapeake Urology Research Associates
🇺🇸
Glen Burnie, Maryland, United States
Site US10560 Chesapeake Urology Research Associates
🇺🇸
Owings Mills, Maryland, United States
Site US10108 Clinical Trial Network
🇺🇸
Houston, Texas, United States
Site US10003 San Diego Clinical Trials
🇺🇸
San Diego, California, United States
Site US10140 IVCTLV
🇺🇸
Las Vegas, Nevada, United States
Site NL31002 Academic Medical Center (AMC)
🇳🇱
Amsterdam, Netherlands
Site NL31005 Canisius-Wilhelmina Ziekenhuis
🇳🇱
Nijmegen, Netherlands
Site NL31001 University Medical Centre Utrecht
🇳🇱
Utrecht, Netherlands
Site CN86025 Beijing Friendship Hospital
🇨🇳
Beijing, China
Site CN86002 Changsha Central Hospital
🇨🇳
Changsha, China
Site CN86009 Peking University 3rd Hospital
🇨🇳
Beijing, China
Site CN86014 The First Hospital Bethune of Jilin University
🇨🇳
Changchun, China
Site CN86027 Second Hospital of Lanzhou University
🇨🇳
Lan Zhou, China
Site CN86020 The First Affiliated Hospital of NanChang Univers
🇨🇳
Nanchang, China
Site CN86021 HuaDong Hosipital Affiliated to Fudan University
🇨🇳
Shanghai, China
Site CN86028 General Hospital of Chengdu Military Region of PLA
🇨🇳
Chengdu, China
Site CN86030 Lanzhou University First Hospital
🇨🇳
Lanzhou, China
Site CN86011 The Second Affiliated Hospital of Soochow Universi
🇨🇳
Suzhou, China
Site CN86003 Shanghai Renji Hospital
🇨🇳
Shanghai, China
Site CN86012 The Fifth People's Hospital of Shanghai
🇨🇳
Shanghai, China
Site CN86010 1st Affiliated Hosptital of Suchow University
🇨🇳
Suzhou, China
Site CN86022 Tongji Hospital, Tongji Medical College of Hust
🇨🇳
Wuhan, China
Site CN86018 Wuxi People's Hospital
🇨🇳
Wuxi, China
Site US10021 Beach Clinical Studies
🇺🇸
Phoenix, Arizona, United States
Site US10109 Lynn Health Science Institute
🇺🇸
Oklahoma City, Oklahoma, United States
Site DK45012 Aalborg Sygehus Nord
🇩🇰
Aalborg, Denmark
Site DK45013 University Hospital of Aarhus, Skejby
🇩🇰
Aarhus, Denmark
Site SE46008 Bragée Medect AB
🇸🇪
Stockholm, Sweden
Site US10034 Urology Center of Colorado
🇺🇸
Denver, Colorado, United States
Site CA15013 Sunnybrook Health Sciences Center
🇨🇦
Toronto, Ontario, Canada
Site CA15020 Diex Research Montreal
🇨🇦
Montreal, Quebec, Canada
Site CA15025 Clinique RSF Inc.
🇨🇦
Quebec, Canada
Site GB44003 Leighton Hospital
🇬🇧
Crewe, United Kingdom
Site GB44024 St James's University Hospital
🇬🇧
Leeds, United Kingdom
Site US10112 TFI, LLC
🇺🇸
Mobile, Alabama, United States
Site US10049 Coastal Clinical Research, Inc.
🇺🇸
Mobile, Alabama, United States
Site US10104 Clinical Research Advantage, Inc.
🇺🇸
Chandler, Arizona, United States
Site US10082 American Clinical Trials
🇺🇸
Hawaiian Gardens, California, United States
Site US10545 San Diego Institute for Sexual Medicine
🇺🇸
San Diego, California, United States
Site US10070 Physicians' Research Options/Red Rocks OB/GYN
🇺🇸
Lakewood, Colorado, United States
Site US10053 Western Clinical Research, Inc.
🇺🇸
Wheat Ridge, Colorado, United States
Site US10153 Palmetto Professional Research
🇺🇸
Hialeah, Florida, United States
Site US10159 Urological Research Network
🇺🇸
Hialeah, Florida, United States
Site US10535 South Florida Medical Research
🇺🇸
Homestead, Florida, United States
Site AU61025 Western Health
🇦🇺
Footscray, Australia
Site US10554 Private Practice
🇺🇸
Plantation, Florida, United States
Site US10540 Demaur Clinical Research, INC
🇺🇸
Pembroke Pines, Florida, United States
Site US10095 Florida Urology Specialists
🇺🇸
Sarasota, Florida, United States
Site US10014 Private Practice
🇺🇸
Wellington, Florida, United States
Site US10010 Southeastern Research Group, Inc
🇺🇸
Tallahassee, Florida, United States
Site US10037 Atlanta Medical Research Institute
🇺🇸
Alpharetta, Georgia, United States
Site US10110 Montana Health Research Institute, Inc.
🇺🇸
Billings, Montana, United States
Site US10152 Female Pelvic Medicine & Urogynecology Institute
🇺🇸
Grand Rapids, Michigan, United States
Site US10051 AdvancedMed Research
🇺🇸
Lawrenceville, New Jersey, United States
Site US10002 Urology Center Research Institute
🇺🇸
Englewood, New Jersey, United States
Site US10047 Lawrence OBGYN Associates
🇺🇸
Lawrenceville, New Jersey, United States
Site US10162 Phoenix OB-GYN Associates, LLC
🇺🇸
Moorestown, New Jersey, United States
Site US10026 AccuMed Research Associates
🇺🇸
Garden City, New York, United States
Site US10077 Northeast Urogynecology
🇺🇸
Albany, New York, United States
Site US10089 Maimonides Medical Center
🇺🇸
Brooklyn, New York, United States
Site US10073 Manhattan Medical Research Practice, PLLC
🇺🇸
New York, New York, United States
Site US10249 New York Clinical Trials
🇺🇸
New York, New York, United States
Site US10040 Premier Medical Group Of The Hudson Valley
🇺🇸
Kingston, New York, United States
Site US10168 Weill Cornell Medical College
🇺🇸
New York, New York, United States
Site US10126 Premier Medical Group
🇺🇸
Newburgh, New York, United States
Site US10076 Carolina Clinical Trials
🇺🇸
Concord, North Carolina, United States
Site US10593 Upstate Clinical Research Associates LLC
🇺🇸
Williamsville, New York, United States
Site US10028 Premier Medical Group of the Hudson Valley
🇺🇸
Poughkeepsie, New York, United States
Site US10129 PMG Research of Raleigh
🇺🇸
Raleigh, North Carolina, United States
Site US10549 Associated Urologists of North Carolina
🇺🇸
Raleigh, North Carolina, United States
Site US10033 Ohio Clinical Research
🇺🇸
Lyndhurst, Ohio, United States
Site US10067 Family Practice Center of Wadsworth
🇺🇸
Wadsworth, Ohio, United States
Site US10551 The Christ Hospital
🇺🇸
West Chester, Ohio, United States
Site US10541 Sunstone Medical Research
🇺🇸
Medford, Oregon, United States
Site US10008 Urologic Consultants of Southeastern Pennsylvania
🇺🇸
Bala-Cynwyd, Pennsylvania, United States
Site US10045 Lancaster Urology
🇺🇸
Lancaster, Pennsylvania, United States
Site US10017 Philadelphia Clinical Research, LLC
🇺🇸
Philadelphia, Pennsylvania, United States
Site US10167 University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Site US10063 Preferred Primary Care Physician Research
🇺🇸
Uniontown, Pennsylvania, United States
Site US10012 Advanced Clinical Concepts
🇺🇸
West Reading, Pennsylvania, United States
Site US10094 University Medical Group
🇺🇸
Greer, South Carolina, United States
Site US10046 Coastal Carolina Research Center
🇺🇸
Mount Pleasant, South Carolina, United States
Site US10117 Carolina Urologic Research Center
🇺🇸
Myrtle Beach, South Carolina, United States
Site US10079 PMG Research of Charleston, LLC
🇺🇸
Mount Pleasant, South Carolina, United States
Site US10006 Holston Medical Group
🇺🇸
Kingsport, Tennessee, United States
Site US10023 Hillcrest Clinical Research, LLC
🇺🇸
Simpsonville, South Carolina, United States
Site US10101 Palmetto Clinical Research
🇺🇸
Summerville, South Carolina, United States
Site US10065 Advanced Research Associates
🇺🇸
Corpus Christi, Texas, United States
Site US10066 Texas Urology PA
🇺🇸
Carrollton, Texas, United States
Site US10085 Centex Studies, Inc.
🇺🇸
Houston, Texas, United States
Site US10219 Methodist Urology Associates
🇺🇸
Houston, Texas, United States
Site US10090 Protenium Clinical Research, LLC
🇺🇸
Hurst, Texas, United States
Site US10093 Pioneer Research Solutions, Inc.
🇺🇸
Houston, Texas, United States
Site US10105 Clinical Trials of Texas
🇺🇸
San Antonio, Texas, United States
Site US10111 Clinical Trials of Texas
🇺🇸
San Antonio, Texas, United States
Site US10092 Physicians' Research Options/Salt Lake Women's Center
🇺🇸
Sandy, Utah, United States
Site US10083 Urology of Virginia, PLLC.
🇺🇸
Virginia Beach, Virginia, United States
Site US10013 Seattle Urology Research Center
🇺🇸
Burien, Washington, United States
Site US10155 Seattle Women's Health, Research, Gynecology
🇺🇸
Seattle, Washington, United States
Site US10135 Walla Walla Clinic
🇺🇸
Walla Walla, Washington, United States
Site AR54005 IUBA - Instituto Urologico de Buenos Aires
🇦🇷
Buenos Aires, Argentina
Site AR54003 Hospital Italiano de Buenos Aires
🇦🇷
Buenos Aires, Argentina
Site AR54006 Hospital Italiano de Buenos Aires
🇦🇷
Buenos Aires, Argentina
Site AR54001 CDU - Centro de Urología
🇦🇷
Ciudad Autónoma Buenos Aires, Argentina
Site AR54004 Instituto de Investigaciones Clnicas Rosario
🇦🇷
Rosario Provincia De Santa Fe, Argentina
Site AU61026 Ballarat Urology
🇦🇺
Ballarat, Australia
Site AU61005 Hunter Clinical Research
🇦🇺
Broadmeadow, Australia
Site AU61012 Cabrini Hospital
🇦🇺
Malvern, Australia
Site AU61010 Nambour General Hospital
🇦🇺
Nambour, Australia
Site AU61015 Repatriation General Hospital
🇦🇺
Daw Park, Australia
Site AU61002 The Royal Womens Hospital
🇦🇺
Parkville, Australia
Site AU61007 Prince of Wales Hospital
🇦🇺
Randwick, Australia
Site CA15031 Centre for Applied Urology Research (CAUR)
🇨🇦
Kingston, Ontario, Canada
Site CA15042 G. Kenneth Jansz Medicine Professional Corporation
🇨🇦
Burlington, Ontario, Canada
Site CA15030 UroLaval
🇨🇦
Laval, Quebec, Canada
Site CA15027 Diex Research Sherbrooke Inc
🇨🇦
Sherbrooke, Quebec, Canada
Site CN86016 Guangzhou First People's Hospital
🇨🇳
Guangzhou, China
Site CN86026 The First Affiliated Hospital of Wenzhou Medical C
🇨🇳
Wenzhou, China
Site CN86015 Zhongnan Hospital of Wuhan University
🇨🇳
Wuhan, China
Site DE49014 Private Practice
🇩🇪
Sangerhausen, Germany
Site CZ42015 Centrum ambulantni gynekologie a primarni pece
🇨🇿
Brno, Czechia
Site CO57004 Instituto de Coloproctologia ICO SAS
🇨🇴
Medellin, Colombia
Site CZ42003 SANUS
🇨🇿
Hradec Kralove, Czechia
Site CZ42007 Uro-Santé/Nová Brumlovka
🇨🇿
Praha 4, Czechia
Site CZ42009 Hospital Uherské Hradiště a.s.
🇨🇿
Uherske Hradiste, Czechia
Site CZ42013 Urology Clinic
🇨🇿
Sternberk, Czechia
Site EE37201 Parnu Hospital
🇪🇪
Parnu, Estonia
Site FR33010 CHU Hopital du Bocage
🇫🇷
Dijon, France
Site FI35801 Kouvolan Lääkäriasema
🇫🇮
Kouvola, Finland
Site FR33007 Centre Hospitalier Louis Pasteur
🇫🇷
Colmar Cedex, France
Site FR33001 Hopital Tenon
🇫🇷
Paris Cedex 20, France
Site FR33024 Hopital Tenon
🇫🇷
Paris Cedex 20, France
Site FR33008 CHU Nantes
🇫🇷
Nantes Cedex 1, France
Site FR33011 Centre Hospitalier Lyon Sud
🇫🇷
Pierre Benite Cedex, France
Site FR33013 Hopital Saint Louis
🇫🇷
Paris, France
Site FR33005 Hopital Bretonneau
🇫🇷
Tours Cedex 9, France
Site FR33012 Hopital Foch
🇫🇷
Suresnes, France
Site DE49008 Private Practice
🇩🇪
Bad Ems, Germany
Site DE49031 Urologisches Zentrum Refrath
🇩🇪
Bergisch Gladbach, Germany
Site DE49033 Universitsy Clinic Bonn
🇩🇪
Bonn, Germany
Site DE49011 Private Practice
🇩🇪
Halle (Saale), Germany
Site DE49013 Private Practice
🇩🇪
Leipzig, Germany
Site DE49002 Private Practice
🇩🇪
Duisburg, Germany
Site DE49032 Urologicum Duisburg
🇩🇪
Duisburg, Germany
Site DE49010 Private Practice
🇩🇪
Ganderkesee, Germany
Site HU36007 Mediroyal Prevention Center
🇭🇺
Kecskemet, Hungary
Site DE49026 Zentrum fuer Onkologie und Urologie Rostock
🇩🇪
Rostock, Germany
Site HK85204 The Chinese Uni of HK, Prince of Wales Hospital
🇭🇰
Hong Kong, Hong Kong
Site HK85203 The Chinese Uni of HK, Prince of Wales Hospital
🇭🇰
Shatin, Hong Kong
Site GR30009 Aretaieio/Maginio
🇬🇷
Athens, Greece
Site IT39007 Azienda Ospedaliera San Giuseppe Moscati
🇮🇹
Avellino, Italy
Site IT39001 U.O. Dip. di Neuro-Urologia; Univ. di Roma La Sapienza
🇮🇹
Latina, Italy
Site HU36012 Veszprém County Cholnoky Ferenc Hospital
🇭🇺
Veszprém, Hungary
Site HU36001 Donatella 99BT
🇭🇺
Szentes, Hungary
Site KR82032 Kyungpook National University Hospital
🇰🇷
Daegu, Korea, Republic of
Site IT39020 Ospedale San Raffaele IRCCS, U.O. di Ginecologia e Ostetricia, Unità Funzionale di Uroginecologia
🇮🇹
Milano, Italy
Site IT39003 Ospedale San Raffaele
🇮🇹
Milan, Italy
Site KR82006 Dong-A University Medical Center
🇰🇷
Busan, Korea, Republic of
Site KR82005 Yeungnam University Hospital
🇰🇷
Daegu, Korea, Republic of
Site KR82014 Soon Chun Hyang University Hospital
🇰🇷
Bucheon-Si, Korea, Republic of
Site KR82024 Chungbuk National University Hospital
🇰🇷
Cheongju-si, Korea, Republic of
Site KR82016 Pusan National University Hospital
🇰🇷
Busan, Korea, Republic of
Site KR82011 Eulji University Hospital
🇰🇷
Daejeon, Korea, Republic of
Site KR82029 Daegu Catholic Univ. Medical Center
🇰🇷
Daegu, Korea, Republic of
Site KR82019 Chungnam National University Hospital
🇰🇷
Daejeon, Korea, Republic of
Site KR82010 Chonbuk National University Hospital
🇰🇷
Jeonju-si, Korea, Republic of
Site KR82031 Chonnam National University Hospital
🇰🇷
Gwangju, Korea, Republic of
Site KR82023 Gachon University Gil Hospital
🇰🇷
Incheon, Korea, Republic of
Site KR82025 Seoul National University Bundang Hospital
🇰🇷
Seongnam-si, Korea, Republic of
Site KR82021 Cheil General Hospital & Women's Healthcare Center
🇰🇷
Seoul, Korea, Republic of
Site KR82030 Severance Hospital
🇰🇷
Seoul, Korea, Republic of
Site KR82020 Seoul National University Hospital
🇰🇷
Seoul, Korea, Republic of
Site KR82013 Hallym University Kangdong Sacred Heart Hospital
🇰🇷
Seoul, Korea, Republic of
Site KR82002 Samsung Medical Center
🇰🇷
Seoul, Korea, Republic of
Site KR82017 Kyung Hee University Medical Center
🇰🇷
Seoul, Korea, Republic of
Site KR82015 Korea University Medical Center
🇰🇷
Seoul, Korea, Republic of
Site KR82001 Seoul Saint Mary's Hospital
🇰🇷
Seoul, Korea, Republic of
Site KR82003 Asan Medical Center
🇰🇷
Seoul, Korea, Republic of
Site LV37102 Private Practice
🇱🇻
Liepaja, Latvia
Site KR82004 Ajou University Hospital
🇰🇷
Suwon-si, Korea, Republic of
Site LV37105 P.Stradins Clinical University Hospital
🇱🇻
Riga, Latvia
Site LT37008 Kaunas 2nd Clinical Hospital
🇱🇹
Kaunas, Lithuania
Site RU70002 Pavlov St. Petersburg State Medical University
🇷🇺
Saint Petersburg, Russian Federation
Site SK42104 Urology Outpatient Department
🇸🇰
Presov, Slovakia
Site SI38604 General Hospital Murska Sobota
🇸🇮
Murska Sobota, Slovenia
Site SI38602 General Hospital Novo Mesto
🇸🇮
Novo Mesto, Slovenia
Site ZA27013 Synexus Clinical Research SA (Pty) Ltd
🇿🇦
Meyerspark, South Africa
Site ZA27007 Paarl Medical Centre
🇿🇦
Paarl, South Africa
Site ZA27006 Parklands Hospital
🇿🇦
Durban, South Africa
Site ES34010 Hospital del Henares
🇪🇸
Coslada, Spain
Site SE46025 Pharmasite
🇸🇪
Helsingborg, Sweden
Site SE46005 Center för Läkemedelsstudier
🇸🇪
Malmö, Sweden
Site SE46012 Karolinska University Hospital Huddinge
🇸🇪
Stockholm, Sweden
Site TH66002 Chulalongkorn Hospital
🇹🇭
Bangkok, Thailand
Site TR90001 Pamukkale University Faculty of Medicine
🇹🇷
Denizli, Turkey
Site TR90013 Uludag University Faculty of Medicine
🇹🇷
Bursa, Turkey
Site GB44022 The Royal Berkshire Hospital
🇬🇧
Reading, United Kingdom
Site ES34005 Hospital de Fuenlabrada
🇪🇸
Madrid, Spain
Site KR82008 Gangnam Severance Hospital
🇰🇷
Seoul, Korea, Republic of
Site RO40014 E-URO Cabinet
🇷🇴
Cluj-Napoca, Romania
Site SG65003 KK Women's and Children's Hospital
🇸🇬
Singapore, Singapore
Site CO57003 Hospital Pablo Tobón Uribe
🇨🇴
Medellin, Antioquia, Colombia
Site FI35802 Meilahti Hospital
🇫🇮
Vantaa, Finland
Site LT37010 Public Institution Vilnius City University Hospital
🇱🇹
Vilnius, Lithuania
Site PH63010 Davao Doctor's Hospital
🇵🇭
Davao City, Philippines
Site PH63004 East Avenue Medical Center
🇵🇭
Quezon City, Philippines
Site RO40001 Spiatlul Clinic Th. Burghele
🇷🇴
Bucuresti, Romania
Site RO40005 Spiatlul Clinic Th. Burghele
🇷🇴
Bucuresti, Romania
Site SG65001 National University Hospital
🇸🇬
Singapore, Singapore
Site SG65002 Singapore General Hospital
🇸🇬
Singapore, Singapore
Site SK42101 Andrologicka a Urologicka Ambulancia
🇸🇰
Kosice, Slovakia
Site FI35803 Oulu University Hospital
🇫🇮
Oulu, Finland
Site MY60002 Sime Darby Medical Centre
🇲🇾
Petaling Jaya, Malaysia
Site PH63008 Dr. Pablo O. Torre Memorial Hospital
🇵🇭
Bacolod City, Philippines
Site RO40010 Spitalul Clinic Judetan de Urgenta Sibiu
🇷🇴
Sibiu, Romania
Site SK42107 Zeleznicne zdravotnictvo Kosice, s.r.o.
🇸🇰
Kosice, Slovakia
Site TH66011 Ramathibodi Hospital
🇹🇭
Ratchathewi, Thailand
Site LT37007 Vilnius University Hospital Santariskiu Klinikos
🇱🇹
Vilnius, Lithuania
Site MY60006 Hospital Pulau Pinang
🇲🇾
Georgetown, Malaysia
Site MX52001 Centro de Investigacin Basica y Clnica
🇲🇽
Guadalajara, Mexico
Site PE51005 Hospital Nacional Hipolito Unanue
🇵🇪
Lima, Peru
Site PH63005 Davao Doctor's Hospital
🇵🇭
Davao City, Philippines
Site RO40004 Spitalul Clinic de Urgenta Sfantul Ioan
🇷🇴
Bucuresti, Romania
Site RO40002 Spitalul Clinic Judetean de Urgenta Timisoara
🇷🇴
Timisoara, Romania
Site MX52003 Clinstile, Sociedad Anonima de Capital Variable
🇲🇽
Mexico City, Mexico
Site MX52002 Accelerium Clinical Research/ Hospital San Jorge
🇲🇽
Monterrey, Mexico
Site NO47007 Medi3 Clinic AS, Ålesund
🇳🇴
Ålesund, Norway
Site PE51001 Instituto de Ginecologia y Reproduccion
🇵🇪
Lima, Peru
Site PE51002 Clinica San Borja
🇵🇪
Lima, Peru
Site PH63009 Chinese General Hospital and Medical Center
🇵🇭
Manila, Philippines
Site RO40007 Spital Clinic
🇷🇴
Iasi, Romania
Site TW88611 Chung Shan Medical University Hospital
🇨🇳
Taichung, Taiwan
Site TH66005 Siriraj Hospital
🇹🇭
Bangkok, Thailand
Site TH66006 Songklanagarind Hospital, Prince of Songkla University
🇹🇭
Hat Yai, Thailand
Site CA15008 Private Practice
🇨🇦
Saint John, New Brunswick, Canada
Site UA38007 Central Outpatient Hospital of Deanyanskyy Distric
🇺🇦
Kiev, Ukraine
Site US10170 Yale - New Haven Hospital West Haven VAMC
🇺🇸
New Haven, Connecticut, United States
Site US10559 UC Davis Medical Center
🇺🇸
Sacramento, California, United States
Site US10124 Winter Park Urology Associates
🇺🇸
Orlando, Florida, United States
Site US10134 Compass Research, LLC
🇺🇸
Orlando, Florida, United States
Site US10062 Piedmont Medical Research
🇺🇸
Winston-Salem, North Carolina, United States
Site US10166 Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Site US10084 Dynamed Clinical Research of Austin,LLC dba DM Clinical Resc
🇺🇸
Austin, Texas, United States
Site US10032 National Clinical Research Inc.
🇺🇸
Richmond, Virginia, United States
Site US10011 Albuquerque Clinical Trials, Inc.
🇺🇸
Albuquerque, New Mexico, United States
Site US10015 Urology Group of New Mexico
🇺🇸
Albuquerque, New Mexico, United States
Site CA15029 Royal Alexandra Hospital
🇨🇦
Edmonton, Alberta, Canada
Site CA15035 Glenrose Rehabilitation Hospital
🇨🇦
Edmonton, Alberta, Canada
Site US10074 Medpharmics, LLC
🇺🇸
Metairie, Louisiana, United States
Site CN86023 Nanjing First Hospital
🇨🇳
Nanjing, China
Site HK85201 Kwong Wah Hospital
🇭🇰
Kowloon, Hong Kong