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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02045862
Registration number
NCT02045862
Ethics application status
Date submitted
23/01/2014
Date registered
27/01/2014
Date last updated
13/09/2018
Titles & IDs
Public title
A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder
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Scientific title
A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate With Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects With Overactive Bladder
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Secondary ID [1]
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2012-005736-29
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Secondary ID [2]
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178-CL-102
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Universal Trial Number (UTN)
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Trial acronym
SYNERGY II
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urinary Bladder Overactive
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Overactive Bladder
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Urgency Incontinence
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Urinary Bladder Diseases\Urologic Diseases
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Condition category
Condition code
Renal and Urogenital
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Solifenacin succinate
Treatment: Drugs - Mirabegron
Treatment: Drugs - Placebo to match solifenacin
Treatment: Drugs - Placebo to match mirabegron
Active Comparator: Mirabegron 50 mg - Participants received mirabegron 50 mg once a day for 52 weeks.
Active Comparator: Solifenacin 5 mg - Participants received solifenacin 5 mg once a day for 52 weeks.
Experimental: Solifenacin 5 mg + Mirabegron 50 mg - Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Treatment: Drugs: Solifenacin succinate
Participants received solifenacin 5 mg orally once a day at the same time each day.
Treatment: Drugs: Mirabegron
Participants received mirabegron 50 mg orally once a day at the same time each day.
Treatment: Drugs: Placebo to match solifenacin
Participants received placebo to match solifenacin 5 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.
Treatment: Drugs: Placebo to match mirabegron
Participants received placebo to match mirabegron 50 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [1]
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A TEAE was defined as an adverse event (AE) observed after taking the first dose of double-blind treatment until 14 days after taking the last dose of double-blind treatment for non-serious AEs and until 30 days after taking the last dose of double-blind treatment for serious adverse events (SAEs). This included abnormal laboratory tests, vital signs or electrocardiogram data that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The severity of each AE was defined according to the following: Mild (No disruption of normal daily activities); Moderate (Affected normal daily activities) and Severe (Inability to perform daily activities).
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Timepoint [1]
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From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)
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Primary outcome [2]
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Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
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Assessment method [2]
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An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and week 52 clinic visits.
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Timepoint [2]
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Baseline and Week 52
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Primary outcome [3]
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Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours
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Assessment method [3]
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A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and week 52 clinic visits.
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Timepoint [3]
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Baseline and Week 52
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Secondary outcome [1]
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Change From Baseline to EoT in Mean Volume Voided Per Micturition
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and Week 52
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Secondary outcome [2]
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Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
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Assessment method [2]
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The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
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Timepoint [2]
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Baseline and Week 52
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Secondary outcome [3]
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Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
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Assessment method [3]
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The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
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Timepoint [3]
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Baseline and Week 52
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Secondary outcome [4]
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Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours
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Assessment method [4]
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An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and prior to each visit.
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Timepoint [4]
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Baseline and Months 1, 3, 6, 9, 12
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Secondary outcome [5]
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Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
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Assessment method [5]
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An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.
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Timepoint [5]
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Months 1, 3, 6, 9, 12
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Secondary outcome [6]
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
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Assessment method [6]
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An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.
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Timepoint [6]
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Baseline and Months 1, 3, 6, 9, 12
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Secondary outcome [7]
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Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit
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Assessment method [7]
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The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period prior to each visit with no incontinence episodes recorded.
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Timepoint [7]
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Months 1, 3, 6, 9, 12
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Secondary outcome [8]
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Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit
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Assessment method [8]
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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.
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Timepoint [8]
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Months 1, 3, 6, 9, 12
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Secondary outcome [9]
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
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Assessment method [9]
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An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.
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Timepoint [9]
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Baseline and Months 1, 3, 6, 9, 12
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Secondary outcome [10]
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Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
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Assessment method [10]
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An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceeded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.
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Timepoint [10]
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Months 1, 3, 6, 9, 12
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Secondary outcome [11]
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
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Assessment method [11]
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An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.
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Timepoint [11]
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Baseline and Months 1, 3, 6, 9, 12
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Secondary outcome [12]
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Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours
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Assessment method [12]
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A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and prior to each visit.
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Timepoint [12]
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Baseline and Months 1, 3, 6, 9, 12
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Secondary outcome [13]
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Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)
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Assessment method [13]
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The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with with less than 8 micturitions per day.
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Timepoint [13]
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Months 1, 3, 6, 9, 12
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Secondary outcome [14]
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Change From Baseline to EoT in Corrected Micturition Frequency
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Assessment method [14]
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Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline. Corrected micturition frequency was calculated as the baseline mean volume voided per micturition multiplied by the baseline mean number of micturitions per 24 hours divided by the mean volume voided per micturition at EoT.
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Timepoint [14]
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Baseline and Month 12
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Secondary outcome [15]
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Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition
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Assessment method [15]
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The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period prior to each visit.
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Timepoint [15]
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Baseline and Months 3, 6, 12
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Secondary outcome [16]
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
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Assessment method [16]
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Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode recorded by the participant in the micturition diary for 7 days prior to each visit as 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
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Timepoint [16]
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Baseline and Months 1, 3, 6, 9, 12
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Secondary outcome [17]
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
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Assessment method [17]
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A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The mean number of nocturia episodes was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit."
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Timepoint [17]
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Baseline and Months 1, 3, 6, 9, 12
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Secondary outcome [18]
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Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit
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Assessment method [18]
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A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit.
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Timepoint [18]
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Months 1, 3, 6, 9, 12
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Secondary outcome [19]
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
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Assessment method [19]
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A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit
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Timepoint [19]
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Baseline and Months 1, 3, 6, 9, 12
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Secondary outcome [20]
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours
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Assessment method [20]
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The mean number of pads used per 24 hours was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit.
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Timepoint [20]
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Baseline and Months 1, 3, 6, 9, 12
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Secondary outcome [21]
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Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit
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Assessment method [21]
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The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.
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Timepoint [21]
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Months 1, 3, 6, 9, 12
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Secondary outcome [22]
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit
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Assessment method [22]
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The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.
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Timepoint [22]
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Baseline and Months 1, 3, 6, 9, 12
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Secondary outcome [23]
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Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score
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Assessment method [23]
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The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
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Timepoint [23]
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Baseline and Months 1, 3, 6, 9, 12
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Secondary outcome [24]
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score
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Assessment method [24]
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The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
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Timepoint [24]
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Baseline and Months 1, 3, 6, 9, 12
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Secondary outcome [25]
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping
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Assessment method [25]
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The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
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Timepoint [25]
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Baseline and Months 1, 3, 6, 9, 12
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Secondary outcome [26]
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern
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Assessment method [26]
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The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
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Timepoint [26]
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Baseline and Months 1, 3, 6, 9, 12
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Secondary outcome [27]
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep
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Assessment method [27]
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The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consisted of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each time was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
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Timepoint [27]
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Baseline and Months 1, 3, 6, 9, 12
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Secondary outcome [28]
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social
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Assessment method [28]
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The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
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Timepoint [28]
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Baseline and Months 1, 3, 6, 9, 12
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Secondary outcome [29]
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Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS
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Assessment method [29]
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The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
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Timepoint [29]
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Baseline and Months 1, 3, 6, 9, 12
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Secondary outcome [30]
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Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)
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Assessment method [30]
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The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
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Timepoint [30]
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Baseline and Months 1, 3, 6, 9, 12
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Secondary outcome [31]
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Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT
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Assessment method [31]
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The PGIC is a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
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Timepoint [31]
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Month 12
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Secondary outcome [32]
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Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT
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Assessment method [32]
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The PGIC is a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
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Timepoint [32]
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Month 12
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Secondary outcome [33]
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Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility
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Assessment method [33]
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The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
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Timepoint [33]
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Baseline and 12 Months
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Secondary outcome [34]
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Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care
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Assessment method [34]
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The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
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Timepoint [34]
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Baseline and Month 12
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Secondary outcome [35]
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Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities
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Assessment method [35]
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0
The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
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Timepoint [35]
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Baseline and Month 12
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Secondary outcome [36]
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Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort
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Assessment method [36]
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0
The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and had 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
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Timepoint [36]
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0
Baseline and Month 12
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Secondary outcome [37]
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Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression
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Assessment method [37]
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The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and had 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
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Timepoint [37]
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0
Baseline and Month 12
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Secondary outcome [38]
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Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed
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Assessment method [38]
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The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
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Timepoint [38]
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Baseline and Months 6,12
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Secondary outcome [39]
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Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
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Assessment method [39]
0
0
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
Query!
Timepoint [39]
0
0
Baseline and Months 6, 12
Query!
Secondary outcome [40]
0
0
Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment
Query!
Assessment method [40]
0
0
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes arre expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
Query!
Timepoint [40]
0
0
Baseline and Months 6, 12
Query!
Secondary outcome [41]
0
0
Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment
Query!
Assessment method [41]
0
0
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
Query!
Timepoint [41]
0
0
Baseline and Months 6, 12
Query!
Secondary outcome [42]
0
0
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT
Query!
Assessment method [42]
0
0
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the last 3 days of the 7-day micturition diary is reported.
Query!
Timepoint [42]
0
0
Months 1, 3, 6, 9, 12
Query!
Secondary outcome [43]
0
0
Percentage of Participants With = 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT
Query!
Assessment method [43]
0
0
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
Query!
Timepoint [43]
0
0
Baseline and Months 1, 3, 6, 9, 12
Query!
Secondary outcome [44]
0
0
Percentage of Participants With = 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT
Query!
Assessment method [44]
0
0
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Query!
Timepoint [44]
0
0
Baseline and Months 1, 3, 6, 9, 12
Query!
Secondary outcome [45]
0
0
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT
Query!
Assessment method [45]
0
0
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.
Query!
Timepoint [45]
0
0
Baseline and Months 1, 3, 6, 9, 12
Query!
Secondary outcome [46]
0
0
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT
Query!
Assessment method [46]
0
0
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the 7-day micturition diary is reported.
Query!
Timepoint [46]
0
0
Months 1, 3, 6, 9, 12
Query!
Secondary outcome [47]
0
0
Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT
Query!
Assessment method [47]
0
0
The percentage of participants with micturition frequency normalization was defined as participants who had = 8 micturitions/24 hours at baseline and < 8 micturitions/24 hours postbaseline at months 1, 3, 6, 9, 12 and EoT.
Query!
Timepoint [47]
0
0
Baseline and Months 1, 3, 6, 9, 12
Query!
Secondary outcome [48]
0
0
Percentage of Participants With = 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT
Query!
Assessment method [48]
0
0
The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Query!
Timepoint [48]
0
0
Baseline and Months 1, 3, 6, 9, 12
Query!
Secondary outcome [49]
0
0
Percentage of Participants With Major (= 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT
Query!
Assessment method [49]
0
0
The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Query!
Timepoint [49]
0
0
Baseline and Months 1, 3, 6, 9, 12
Query!
Secondary outcome [50]
0
0
Percentage of Participants Who Were Double Responders (= 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Months 1, 3, 6, 9, 12 and EoT
Query!
Assessment method [50]
0
0
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
Query!
Timepoint [50]
0
0
Baseline and Months 1, 3, 6, 9, 12
Query!
Secondary outcome [51]
0
0
Percentage of Participants Who Were Double Responders (= 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Months 1, 3, 6, 9, 12 and EoT
Query!
Assessment method [51]
0
0
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Query!
Timepoint [51]
0
0
Baseline and Months 1, 3, 6, 9, 12
Query!
Secondary outcome [52]
0
0
Percentage of Participants Who Were Double Responders (= 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
Query!
Assessment method [52]
0
0
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Query!
Timepoint [52]
0
0
Baseline and Months 1, 3, 6, 9, 12
Query!
Secondary outcome [53]
0
0
Percentage of Participants Who Were Triple Responders (= 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, = 10 Points Improvement on OAB-q Symptom Bother Scale and =1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
Query!
Assessment method [53]
0
0
The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The symptom bother portion of the OAB-q consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Query!
Timepoint [53]
0
0
Baseline and Months 1, 3, 6, 9, 12
Query!
Secondary outcome [54]
0
0
Participants Who Were Triple Responders (= 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, = 10 Points Improvement on OAB-q HRQL Total Score and = 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
Query!
Assessment method [54]
0
0
The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The HRQoL portion of the OAB-q consists of 25 HRQoL items comprising 4 HRQoL subscales, each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Query!
Timepoint [54]
0
0
Baseline and Months 1, 3, 6, 9, 12
Query!
Secondary outcome [55]
0
0
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume
Query!
Assessment method [55]
0
0
PVR volume was assessed by ultrasonography or a bladder scanner.
Query!
Timepoint [55]
0
0
Baseline and Months 1, 3, 6, 9, 12
Query!
Eligibility
Key inclusion criteria
Main Inclusion at Screening (Visit 1):
- Subject had completed study 178-CL-101 or study 905-EC-012 (This inclusion criterion
would no longer apply once the recruitment for study 178-CL-101 and study 905-EC-012
had been completed. In that case the subject had to have symptoms of "wet" OAB
(urinary frequency and urgency with incontinence) for at least 3 months);
- Subject was willing and able to complete the micturition diary and questionnaires
correctly and able to measure his/her vital signs at home at stipulated time points,
using the device provided by the study personnel, and to adequately record the
readings;
Main Inclusion at Randomization (Visit 2):
- Subject had a micturition frequency of on average = 8 times per 24-hour period during
the last 7 days of the micturition diary period (incontinence episode should not be
counted as a micturition).
- Subject had experienced at least 3 incontinence episodes during the last 7 days of the
micturition diary period.
- Subject had experienced on average at least 1 urgency episode (grade 3 or 4 on Patient
Perception of Intensity of Urgency Scale [PPIUS]) per 24-hour period during the 7-day
micturition diary period.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Main Exclusion at Screening (Visit 1):
- Subject had clinically significant bladder outflow obstruction at risk of urinary
retention;
- Subject had significant PVR volume (> 150 mL);
- Subject had significant stress incontinence or mixed stress/urgency incontinence where
stress is the predominant factor;
- Subject has an indwelling catheter or practices intermittent self-catheterization;
- Subject had evidence of a UTI (urine culture containing > 100,000 cfu/mL), chronic
inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation
therapy or previous or current malignant disease of the pelvic organs;
- Subject had intravesical treatment in the past 12 months with e.g., botulinum toxin,
resiniferatoxin, capsaicin;
Main Exclusion at Randomization (Visit 2):
- Subject had evidence of a urinary tract infection (UTI) (urine culture containing >
100,000 cfu/mL) as assessed in the Screening visit (V1) samples. The subject could be
rescreened after successful treatment of the UTI (confirmed by a dipstick negative for
nitrite).
- Subject had an average total daily urine volume > 3000 mL as recorded in the
micturition diary period.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
17/03/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
8/09/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1829
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Site AU61005 - Broadmeadow
Query!
Recruitment hospital [2]
0
0
Site AU61007 - Randwick
Query!
Recruitment hospital [3]
0
0
Site AU61021 - Randwick
Query!
Recruitment hospital [4]
0
0
Site AU61011 - Wollongong
Query!
Recruitment hospital [5]
0
0
Site AU61022 - Brisbane
Query!
Recruitment hospital [6]
0
0
Site AU61010 - Nambour
Query!
Recruitment hospital [7]
0
0
Site AU61019 - Sherwood
Query!
Recruitment hospital [8]
0
0
Site AU61015 - Daw Park
Query!
Recruitment hospital [9]
0
0
Site AU61025 - Footscray
Query!
Recruitment hospital [10]
0
0
Site AU61002 - Parkville
Query!
Recruitment hospital [11]
0
0
Site AU61004 - Perth
Query!
Recruitment postcode(s) [1]
0
0
2292 - Broadmeadow
Query!
Recruitment postcode(s) [2]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [3]
0
0
2522 - Wollongong
Query!
Recruitment postcode(s) [4]
0
0
4152 - Brisbane
Query!
Recruitment postcode(s) [5]
0
0
4560 - Nambour
Query!
Recruitment postcode(s) [6]
0
0
4075 - Sherwood
Query!
Recruitment postcode(s) [7]
0
0
5041 - Daw Park
Query!
Recruitment postcode(s) [8]
0
0
3011 - Footscray
Query!
Recruitment postcode(s) [9]
0
0
3052 - Parkville
Query!
Recruitment postcode(s) [10]
0
0
6009 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kansas
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Louisiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Montana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Nebraska
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New Jersey
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Mexico
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New York
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
North Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Ohio
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Oklahoma
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Oregon
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Pennsylvania
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
South Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Tennessee
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Texas
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Virginia
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Washington
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Gent
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Roeselare
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Sint-Truiden
Query!
Country [29]
0
0
Bulgaria
Query!
State/province [29]
0
0
Plovdiv
Query!
Country [30]
0
0
Bulgaria
Query!
State/province [30]
0
0
Ruse
Query!
Country [31]
0
0
Bulgaria
Query!
State/province [31]
0
0
Sofia
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
Alberta
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
British Columbia
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
New Brunswick
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Ontario
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
Quebec
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Montreal
Query!
Country [38]
0
0
Czechia
Query!
State/province [38]
0
0
Brno
Query!
Country [39]
0
0
Czechia
Query!
State/province [39]
0
0
Hradec Kralove
Query!
Country [40]
0
0
Czechia
Query!
State/province [40]
0
0
Olomouc
Query!
Country [41]
0
0
Czechia
Query!
State/province [41]
0
0
Ostrava
Query!
Country [42]
0
0
Czechia
Query!
State/province [42]
0
0
Plzen
Query!
Country [43]
0
0
Czechia
Query!
State/province [43]
0
0
Praha 2
Query!
Country [44]
0
0
Czechia
Query!
State/province [44]
0
0
Praha 4
Query!
Country [45]
0
0
Czechia
Query!
State/province [45]
0
0
Sternberk
Query!
Country [46]
0
0
Czechia
Query!
State/province [46]
0
0
Uherske Hradiste
Query!
Country [47]
0
0
Czechia
Query!
State/province [47]
0
0
Usti nad Labem
Query!
Country [48]
0
0
Denmark
Query!
State/province [48]
0
0
Aarhus
Query!
Country [49]
0
0
Estonia
Query!
State/province [49]
0
0
Parnu
Query!
Country [50]
0
0
Finland
Query!
State/province [50]
0
0
Kouvola
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Bavaria
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Northwest
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
NRW
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Sachsen Anhalt
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Sachsen
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Bad Ems
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
Duisburg
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Ganderkesee
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Halle (Saale)
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Neustadt I. Sachsen
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Rostock
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Sangerhausen
Query!
Country [63]
0
0
Hungary
Query!
State/province [63]
0
0
Bacs-Kiskun Megye
Query!
Country [64]
0
0
Hungary
Query!
State/province [64]
0
0
Baranya Megye
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Country [65]
0
0
Hungary
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State/province [65]
0
0
Csongrad Megye
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Country [66]
0
0
Hungary
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State/province [66]
0
0
Gyor-Moson Sopron
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Country [67]
0
0
Hungary
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State/province [67]
0
0
Veszprem Megye
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Country [68]
0
0
Italy
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State/province [68]
0
0
Ancona
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Country [69]
0
0
Italy
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State/province [69]
0
0
Avellino
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Country [70]
0
0
Italy
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State/province [70]
0
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Latina
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Country [71]
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0
Italy
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State/province [71]
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0
Milano
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Country [72]
0
0
Korea, Republic of
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State/province [72]
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Gyeonggi-do
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Country [73]
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Korea, Republic of
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State/province [73]
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0
Gyunggido
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Country [74]
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Korea, Republic of
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State/province [74]
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Jeollabuk-do South Korea
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Country [75]
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Korea, Republic of
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State/province [75]
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0
Busan
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Country [76]
0
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Korea, Republic of
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State/province [76]
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Daegu
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Country [77]
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Korea, Republic of
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State/province [77]
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0
Daejeon
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Country [78]
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Korea, Republic of
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State/province [78]
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Incheon
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Country [79]
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Korea, Republic of
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State/province [79]
0
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Seoul
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Country [80]
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0
Latvia
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State/province [80]
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Liepaja
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Country [81]
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Latvia
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State/province [81]
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Olaine
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Country [82]
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Latvia
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State/province [82]
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Riga
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Country [83]
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Lithuania
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State/province [83]
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Kaunas
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Country [84]
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Lithuania
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State/province [84]
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Klaipeda
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Country [85]
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Lithuania
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State/province [85]
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Vilnius
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Country [86]
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Malaysia
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State/province [86]
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Petaling Jaya
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Country [87]
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0
Mexico
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State/province [87]
0
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DF
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Country [88]
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0
Netherlands
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NL
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Country [89]
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Netherlands
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State/province [89]
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Amsterdam
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Country [90]
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Netherlands
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State/province [90]
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Nijmegen
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Country [91]
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Netherlands
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State/province [91]
0
0
Sneek
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Country [92]
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0
New Zealand
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State/province [92]
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Canterbury
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Country [93]
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New Zealand
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State/province [93]
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Nelson
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Country [94]
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New Zealand
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State/province [94]
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Tauranga
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Country [95]
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0
New Zealand
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State/province [95]
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Whangarei
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Country [96]
0
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Norway
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State/province [96]
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Alesund
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Country [97]
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0
Norway
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State/province [97]
0
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Hamar
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Country [98]
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Norway
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State/province [98]
0
0
Lierskogen
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Country [99]
0
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Poland
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State/province [99]
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Bialystok
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Country [100]
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Poland
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State/province [100]
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Chorzow
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Country [101]
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Poland
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State/province [101]
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Gdynia
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Country [102]
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Poland
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State/province [102]
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Lodz
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Country [103]
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Poland
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State/province [103]
0
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Lublin
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Country [104]
0
0
Poland
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State/province [104]
0
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Myslowice
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Country [105]
0
0
Poland
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State/province [105]
0
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Opole
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Country [106]
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Poland
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State/province [106]
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Piaseczno
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Country [107]
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Poland
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State/province [107]
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Warsaw
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Country [108]
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Poland
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State/province [108]
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Warszawa
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Country [109]
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Poland
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State/province [109]
0
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Wroclaw
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Country [110]
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Romania
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State/province [110]
0
0
Cluj
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Country [111]
0
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Romania
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State/province [111]
0
0
Bucuresti
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Country [112]
0
0
Romania
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State/province [112]
0
0
Sibiu
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Country [113]
0
0
Romania
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State/province [113]
0
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Timisoara
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Country [114]
0
0
Russian Federation
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State/province [114]
0
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Kazan
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Country [115]
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0
Russian Federation
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State/province [115]
0
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Penza
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Country [116]
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Russian Federation
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State/province [116]
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Saint Petersburg
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Country [117]
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0
Russian Federation
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State/province [117]
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0
St. Petersburg
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Country [118]
0
0
Russian Federation
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State/province [118]
0
0
Ufa
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Country [119]
0
0
Singapore
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State/province [119]
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Singapore
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Country [120]
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0
Slovakia
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State/province [120]
0
0
Bratislava
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Country [121]
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0
Slovakia
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State/province [121]
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Kosice
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Country [122]
0
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Slovakia
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State/province [122]
0
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Nitra
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Country [123]
0
0
Slovakia
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State/province [123]
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Poprad
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Country [124]
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0
Slovakia
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State/province [124]
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0
Prešov
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Country [125]
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Slovakia
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State/province [125]
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Trencin
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Country [126]
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Slovenia
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State/province [126]
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0
Murska Sobota
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Country [127]
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South Africa
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State/province [127]
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Gauteng
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Country [128]
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South Africa
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State/province [128]
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0
Kwa Zulu Natal
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Country [129]
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0
South Africa
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State/province [129]
0
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Pretoria
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Country [130]
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0
South Africa
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State/province [130]
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0
Western Cape
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Country [131]
0
0
Spain
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State/province [131]
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Madrid
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Country [132]
0
0
Spain
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State/province [132]
0
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Valencia
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Country [133]
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0
Sweden
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State/province [133]
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Boras
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Country [134]
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Sweden
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State/province [134]
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Malmo
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Country [135]
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Sweden
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Stockholm
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Country [136]
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Sweden
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State/province [136]
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Uppsala
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Country [137]
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Thailand
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State/province [137]
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Bangkok
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Country [138]
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Thailand
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State/province [138]
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0
Khon Kaen
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Country [139]
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Ukraine
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State/province [139]
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0
Cherenigiv
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Country [140]
0
0
Ukraine
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State/province [140]
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0
Chernivtsi
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Country [141]
0
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Ukraine
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State/province [141]
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0
Dnepropetrovsk
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Country [142]
0
0
Ukraine
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State/province [142]
0
0
Kiev
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Country [143]
0
0
Ukraine
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State/province [143]
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Kyiv
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Country [144]
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Ukraine
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State/province [144]
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0
Zaporizhzhya
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Country [145]
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0
United Kingdom
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State/province [145]
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0
South Yorkshire
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Country [146]
0
0
United Kingdom
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State/province [146]
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0
Plymouth
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Country [147]
0
0
United Kingdom
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State/province [147]
0
0
Watford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Astellas Pharma Europe B.V.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study was to examine how well the combination of two medicines
(solifenacin succinate and mirabegron) worked compared to each medicine alone in the
treatment of bladder problems, and how safe they were for long term use.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02045862
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Medical Director
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Address
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0
Astellas Pharma Europe B.V.
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Country
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0
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Phone
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Fax
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0
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Email
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Contact person for public queries
Name
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02045862
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