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CompletedNCT01908829BESIDEUpdated Oct 31, 2024Results posted

A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)

A Phase 3 interventional study of mirabegron 25 mg and mirabegron 50 mg in Urinary Bladder Diseases, Urinary Bladder Overactive and Urologic Diseases, sponsored by Astellas Pharma Europe Ltd.. Completed at 219 sites in 31 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-31.

Primary conditionUrinary Bladder, OveractiveRegistry: Urinary Bladder DiseasesReclassifiedWhy we changed it
Registry
Urinary Bladder Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Urinary Bladder, Overactive
Why
  1. The study's listed conditions name Urinary Bladder, Overactive, a narrower term within Urinary Bladder Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Astellas Pharma Europe Ltd. (part of Astellas Pharma Inc) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
2,174
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study was to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be more effective in controlling incontinence than when using the antimuscarinic treatment alone.

02

Conditions studied

  • Urinary Bladder Diseases
  • Urinary Bladder Overactive
  • Urologic Diseases

Keywords

  • Vesitrim
  • Betanis
  • Urgency
  • Frequency
  • Mirabegron
  • YM178
  • Betmiga
  • Vesicare
  • Micturition
  • YM905
  • Solifenacin
  • Urinary incontinence
  • Overactive Bladder (OAB)
  • Myrbetriq
  • Vesikur
  • Urgency incontinence
03

In context

Urinary Bladder, Overactive Reclassified

858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.

This study's enrollment of 2,174 is above the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Astellas Pharma Europe Ltd. is the lead sponsor of 31 studies on the registry; 2 are open to participants now.

Browse Astellas Pharma Europe B.V. studies →All Astellas Pharma Inc studies →

Compared within Urinary Bladder, Overactive, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urinary Bladder Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Main Inclusion at Screening:

    1. Subject has symptoms of OAB (urinary frequency and urgency with urgency incontinence) for >= 3 months prior to the screening visit
    2. Subject is willing and able to complete the micturition diary and questionnaires correctly, including collection and measurement of urine output for 3 days prior to each visit;
    3. Subject has symptoms of "wet" OAB (urinary frequency and urgency with incontinence or mixed incontinence with predominant urgency incontinence), and reports an average of at least 2 incontinence episodes per day.

  • Main Inclusion at Run-in (Visit 2):

    1. Subject experiences on average at least 1 episode of urgency (grade 3 or 4) with or without incontinence per 24-hour period during the 3-day micturition diary period.
    2. Subject experiences on average at least 2 incontinence episodes per 24-hour period during the 3-day micturition diary period.
    3. Subject experiences on average at least 8 micturitions (excluding incontinence episodes) per 24-hour period during the 3-day micturition diary period.

  • Main Inclusion at Randomization (Visit 3):

    1. Subject experiences at least 1 incontinence episode during the 3-day micturition diary period and wishes to increase their treatment for OAB symptoms.

Exclusion criteria

Exclusion Criteria:

  • Main Exclusion at Screening:

    1. Subject in the opinion of the investigator has Bladder Outlet Obstruction (BOO).
    2. Subject has significant Post-void residual (PVR) volume (PVR > 150 ml).
    3. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator
    4. Subject has an indwelling catheter or practices intermittent self catheterization.
    5. Subject has evidence of a UTI.
    6. Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs
    7. Subject has moderate to severe hepatic impairment
    8. Subject has severe renal impairment or End Stage Renal disease
    9. Subject has a clinically significant abnormal (ECG)
    10. Subject has a concurrent or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
    11. Subject has a interval > 450 ms for males or > 470 ms for females or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
    12. Subject has received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
    13. Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.

  • Main Exclusion at Randomization (visit 3):

    1. Subject has achieved 100% continence from Visit 2 to Visit 3 (no incontinence episodes are recorded in the 3 day diary administered for 3 days prior to Visit 3).
    2. Subject does not desire an increase in study medication.
    3. Subject has an average total daily urine volume > 3000ml as recorded in the micturition diary.
    4. Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.
    5. Subject has a clinically significant abnormal ECG
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
2,174 participants (actual)

Study arms

  • Experimental
    Combination (solifenacin + mirabegron)

    Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.

    Drug: mirabegron 25 mg · Drug: mirabegron 50 mg · Drug: solifenacin 5 mg · Drug: solifenacin 10 mg matching placebo

  • Active comparator
    Solifenacin 5 mg

    Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period

    Drug: solifenacin 5 mg · Drug: mirabegron 25 mg matching placebo · Drug: mirabegron 50 mg matching placebo · Drug: solifenacin 10 mg matching placebo

  • Active comparator
    Solifenacin 10 mg

    Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.

    Drug: solifenacin 10 mg · Drug: mirabegron 25 mg matching placebo · Drug: mirabegron 50 mg matching placebo · Drug: solifenacin 5 mg matching placebo

Interventions

  • Drugmirabegron 25 mg

    Mirabegron was supplied as the marketed formulation in the 25 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.

    Also known as: Betmiga, Myrbetriq, YM178, Betanis

  • Drugmirabegron 50 mg

    Mirabegron was supplied as the marketed formulation in the 50 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.

    Also known as: YM905, Vesitrim, Vesikur, Vesicare

  • Drugsolifenacin 5 mg

    Solifenacin was provided as the marketed formulation in the 5 mg strength. Medication was taken orally with a glass of water, with or without food.

    Also known as: Vesicare, Vesitrim, YM905, Vesikur

  • Drugsolifenacin 10 mg

    Solifenacin was provided as the marketed formulation in the 10 mg strength. Medication was taken orally with a glass of water, with or without food.

    Also known as: Vesicare, Vesitrim, YM905, Vesikur

  • Drugmirabegron 25 mg matching placebo

    Matching placebo of mirabegron OCAS 25 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

  • Drugmirabegron 50 mg matching placebo

    Matching placebo of mirabegron OCAS 50 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

  • Drugsolifenacin 5 mg matching placebo

    Matching placebo of solifenacin succinate 5 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

  • Drugsolifenacin 10 mg matching placebo

    Matching placebo of solifenacin succinate 10 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

06

What researchers measure

Primary outcomes

  1. Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours

    The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition in the baseline diary \& at least 1 micturition postbaseline \& reported at least 1 incontinence episode in the baseline diary. For participants who withdrew before EoT (week 12) and have no measurement available for that diary period, the Last Observation Carried Forward (LOCF) value during the double-blind study period was used as EoT value to derive the primary variable.

    Time frame: Baseline and end of treatment (up to 12 weeks)

Secondary outcomes

  1. Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours

    The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period.

    Time frame: Baseline and weeks 4, 8 & 12

  2. Change From Baseline in Mean Number of Micturitions Per 24 Hours

    The average number of micturitions (voluntary urinations (excluding incontinence only episodes)) per 24 hours was derived from number of micturitions recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period (excluding incontinence only episodes).

    Time frame: Baseline and weeks 4, 8 & 12

  3. Number of Incontinence Episodes Reported During the 3-Day Diary

    The number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from total number of incontinence episodes on valid diary days recorded during the 3-day micturition diary period.

    Time frame: Weeks 4, 8 and 12

  4. Change From Baseline in Mean Volume Voided (MVV) Per Micturition

    MVV per micturition was defined as MVV (mL) per micturition during last 3 days of the 3-day micturition diary period. MVV per micturition was calculated as the sum of each volume voided for each record with volume voided \> 0 on valid diary days divided by the total number of records with a volume voided \> 0 on valid diary days during the 3-day micturition diary period.

    Time frame: Baseline and weeks 4, 8 & 12

  5. Change From Baseline to EoT in Corrected Micturition Frequency (CMF)

    CMF was defined as the mean number of micturitions per 24 hours that participants would have at EoT if their fluid intake had remained unchanged since baseline. This was calculated by the MVV per Micturition at baseline multiplied by the mean number of micturitions per 24 hours at baseline divided by the MVV per micturition at EoT.

    Time frame: Baseline and EoT (up to 12 weeks)

  6. Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours

    UI was defined as the complaint of involuntary urine leakage accompanied by or immediately preceded by urgency. UI was measured using the Patient Perception of Intensity of Urgency Scale (PPIUS), a patient reported outcome validated 5-point categorical scale rating the degree of associated urinary urgency severity (0=No urgency, I felt no need to empty my bladder, but did so for other reasons. 1=Mild, I could postpone voiding as long as necessary, without fear of wetting myself. 2= Moderate, I could postpone voiding for a short while, without fear of wetting myself. 3=Severe, I could not postpone voiding, but had to rush to the toilet in order not to wet myself. 4=Urgency incontinence, I leaked before arriving to the toilet). One urgency incontinence episode was counted for each record of the diary in which the following occurred: incontinence episode or 'both' was recorded \& severity of urinary urgency recorded was 3 or 4.

    Time frame: Baseline and weeks 4, 8 & 12

  7. Number of UI Episodes Reported During the 3-Day Diary

    Number of UI episodes was calculated using the number of UI episodes recorded on valid diary days during the 3-day micturition diary period. NOTE: Only urgency incontinence episodes recorded on a valid diary day were counted.

    Time frame: Weeks 4, 8 and 12

  8. Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours

    An urgency episode was defined as the complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes (severity of 3 or 4) per 24 hours was defined as the average number of times a participant recorded an urgency episode (severity of 3 or 4) with or without incontinence per day during the 3-day micturition diary period. Measured using the PPIUS scale. This was calculated using the sum of each record with an urgency episode (severity of 3 or 4) recorded on a valid diary day divided by the number of valid diary days during the 3-day micturition diary period.

    Time frame: Baseline and weeks 4, 8 & 12

  9. Change From Baseline in Mean Number of Pads Per 24 Hours

    The mean number of pads per 24 hours was defined as the average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. This was calculated using the number of new pads used during valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period.

    Time frame: Baseline and weeks 4, 8 & 12

  10. Number of Pads Used During the 3-Day Diary

    The number of pads used was defined as the number of times a participant recorded a new pad used during the 3-day micturition diary period. This was calculated using the sum of each record with new pad checked. Only records with new pad checked on a valid diary day were counted.

    Time frame: Weeks 4, 8 and 12

  11. Change From Baseline in Mean Number of Nocturia Episodes

    Mean number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) while sleeping during the 3-day diary period, divided by the number of valid diary days during the diary period. Night time episode of incontinence only was not considered a nocturia episode. Nocturia episodes were counted for each micturition record which occurred between the date/time of going to bed with intention to sleep and the date/time of getting up with intention to stay awake on a valid diary day \& which was accompanied by a sleep interruption. Nocturia only determined for those who were not night-shift workers.

    Time frame: Baseline and weeks 4, 8 & 12

  12. Number of Nocturia Episodes Reported Over 3-Day Diary

    The number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) during sleeping time during the 3-day micturition diary period. This was calculated using the sum of each nocturia episode recorded on valid diary days during the 3-day micturition diary period.

    Time frame: Weeks 4, 8 and 12

  13. Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility

    The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

    Time frame: Baseline and EoT (up to 12 weeks)

  14. Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care

    The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

    Time frame: Baseline and EoT (up to 12 weeks)

  15. Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities

    The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

    Time frame: Baseline and EoT (up to 12 weeks)

  16. Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort

    The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

    Time frame: Baseline and EoT (up to 12 weeks)

  17. Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression

    The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

    Time frame: Baseline and EoT (up to 12 weeks)

  18. Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score

    The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity).

    Time frame: Baseline and weeks 4, 8 & 12

  19. Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score

    The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

    Time frame: Baseline and weeks 4, 8 & 12

  20. Change From Baseline in OAB-q HRQL Subscale Score: Coping

    The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

    Time frame: Baseline and weeks 4, 8 & 12

  21. Change From Baseline in OAB-q HRQL Subscale Score: Concern

    The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

    Time frame: Baseline and weeks 4, 8 & 12

  22. Change From Baseline in OAB-q HRQL Subscale Score: Sleep

    The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

    Time frame: Baseline and weeks 4, 8 & 12

  23. Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction

    The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

    Time frame: Baseline and weeks 4, 8 & 12

  24. Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score

    The TS-VAS rated participant satisfaction with treatment on a scale from 0 (No, not at all) to 10 (Yes, completely).

    Time frame: Baseline and weeks 4, 8 & 12

  25. Change From Baseline in Patient Perception Bladder Control (PPBC) Score

    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. PPBC score: 1-no problem, 2- some very minor problems, 3-some minor problems, 4-moderate problems, 5-severe problems, 6-many severe problems.

    Time frame: Baseline and weeks 4, 8 & 12

  26. Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC)

    The PGIC was a 2-part questionnaire, assessing both the change in the participant's overall condition (Patient Impression in General Health (PIBS)) and change in bladder condition since the start of the study (Patient Impression in General Health (PIGH)) (from very much worse to very much improved). The CGIC was a single questionnaire assessing the participant's change in bladder condition since the beginning of the study (Clinician Impression in Bladder Symptoms (CIBS)).

    Time frame: End of treatment (up to 12 weeks)

  27. Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours

    Incontinence was defined as any involuntary leakage of urine.

    Time frame: Weeks 4, 8 and 12

  28. Percentage of Participants With Zero Incontinence Episodes Postbaseline

    Incontinence was defined as any involuntary leakage of urine.

    Time frame: Weeks 4, 8 and 12

  29. Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline

    Micturitions were defined as voluntary urinations (excluding incontinence only episodes).

    Time frame: Weeks 4, 8 and 12

  30. Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score

    The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity).

    Time frame: Weeks 4, 8 and 12

  31. Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score

    HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

    Time frame: Weeks 4, 8 and 12

  32. Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC

    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.

    Time frame: Weeks 4, 8 and 12

  33. Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC

    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.

    Time frame: Weeks 4, 8 and 12

  34. Number of Participants With Adverse Events (AEs)

    AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures \& which does not necessarily have a causal relationship with this treatment. Treatment-Emergent Adverse Event (TEAE) referred to an adverse event which started or worsened in the period from first double-blind medication intake until 30 days after the last double-blind medication intake.

    Time frame: From first dose of double blind treatment until 30 days after last dose (up to 16 weeks)

  35. Change From Baseline in Post Void Residual (PVR) Volume

    PVR Volume was assessed by bladder scan.

    Time frame: Baseline and weeks 4, 8 & 12

07

Results

Posted Oct 9, 2017
Limitations and caveats
One participant was randomized to the Combination arm, but actually received Solifenacin 10 mg. In terms of actual treatment received, the participant was allocated to the solifenacin 10 mg arm.

Participant flow

This multicenter study was conducted at 281 centers globally. Randomization was stratified by sex, age group (\< 65, ≥ 65 years), 4-week incontinence episode reduction group (\< 50%, ≥ 50%) and geographic region.

Participant flow — Overall Study
MilestoneCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Started727728719
Treated with double-blind drug725728719
Completed678679680
Not completed494939
Withdrew: Adverse event131113
Withdrew: Lost to follow-up421
Withdrew: Randomized no double-blind drug received101
Withdrew: Discontinued (no eot page)200
Withdrew: Miscellaneous020
Withdrew: Protocol violation220
Withdrew: Lack of efficacy132
Withdrew: Withdrawal by subject262922

Outcome measures

PrimaryChange From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours

The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition in the baseline diary \& at least 1 micturition postbaseline \& reported at least 1 incontinence episode in the baseline diary. For participants who withdrew before EoT (week 12) and have no measurement available for that diary period, the Last Observation Carried Forward (LOCF) value during the double-blind study period was used as EoT value to derive the primary variable.

Time frame:
Baseline and end of treatment (up to 12 weeks)
Reported as:
Least squares mean · incontinence episodes
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
incontinence episodesCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours-1.8 ± 0.08-1.53 ± 0.08-1.67 ± 0.08
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · stratified rank ANCOVA · p = =0.001 (P values for pairwise comparisons were from the stratified rank ANCOVA model. P \< 0.05 indicated superiority in favor of treatment group with the largest improvement.) · Least squares (ls) means: -0.26 · 95% CI -0.47 to -0.05
SecondaryChange From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours

The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period.

Time frame:
Baseline and weeks 4, 8 & 12
Reported as:
Least squares mean · incontinence episodes
Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours
incontinence episodesCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 4-1.24 ± 0.07-0.91 ± 0.07-1.12 ± 0.07
Week 8-1.68 ± 0.07-1.29 ± 0.07-1.49 ± 0.07
Week 12-1.81 ± 0.08-1.57 ± 0.08-1.67 ± 0.08
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · stratified rank ANCOVA · p = <0.001 (P values for pairwise comparisons are from the stratified rank ANCOVA model. P \< 0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.33 · 95% CI -0.52 to -0.14
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · stratified rank ANCOVA · p = <0.001 (P values for pairwise comparisons are from the stratified rank ANCOVA model. P \< 0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.39 · 95% CI -0.60 to -0.18
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · stratified rank ANCOVA · p = =0.001 (P-values for pairwise comparisons are from the stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.25 · 95% CI -0.46 to -0.03
SecondaryChange From Baseline in Mean Number of Micturitions Per 24 Hours

The average number of micturitions (voluntary urinations (excluding incontinence only episodes)) per 24 hours was derived from number of micturitions recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period (excluding incontinence only episodes).

Time frame:
Baseline and weeks 4, 8 & 12
Reported as:
Least squares mean · micturitions
Change From Baseline in Mean Number of Micturitions Per 24 Hours
micturitionsCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 4-0.95 ± 0.07-0.69 ± 0.07-0.79 ± 0.07
Week 8-1.36 ± 0.08-0.94 ± 0.08-1.00 ± 0.08
Week 12-1.63 ± 0.08-1.16 ± 0.09-1.11 ± 0.08
EoT-1.59 ± 0.08-1.14 ± 0.08-1.12 ± 0.08
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.010 (P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.26 · 95% CI -0.47 to -0.06
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.42 · 95% CI -0.65 to -0.19
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.47 · 95% CI -0.70 to -0.23
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.45 · 95% CI -0.67 to -0.22
SecondaryNumber of Incontinence Episodes Reported During the 3-Day Diary

The number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from total number of incontinence episodes on valid diary days recorded during the 3-day micturition diary period.

Time frame:
Weeks 4, 8 and 12
Reported as:
Mean · incontinence episodes
Number of Incontinence Episodes Reported During the 3-Day Diary
incontinence episodesCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 45.81 ± 0.306.68 ± 0.316.41 ± 0.33
Week 84.55 ± 0.305.43 ± 0.305.28 ± 0.32
Week 124.03 ± 0.294.56 ± 0.284.62 ± 0.31
EoT4.25 ± 0.294.87 ± 0.284.72 ± 0.31
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Mixed Effects Poisson · p = =0.005 (p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.) · Rate ratio: 0.87 · 95% CI 0.79 to 0.96
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Mixed Effects Poisson · p = <0.001 (p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.) · Rate ratio: 0.75 · 95% CI 0.66 to 0.86
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Mixed Effects Poisson · p = =0.021 (p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.) · Rate ratio: 0.82 · 95% CI 0.70 to 0.97
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Mixed Effects Poisson · p = =0.014 (p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.) · Rate ratio: 0.82 · 95% CI 0.71 to 0.96
SecondaryChange From Baseline in Mean Volume Voided (MVV) Per Micturition

MVV per micturition was defined as MVV (mL) per micturition during last 3 days of the 3-day micturition diary period. MVV per micturition was calculated as the sum of each volume voided for each record with volume voided \> 0 on valid diary days divided by the total number of records with a volume voided \> 0 on valid diary days during the 3-day micturition diary period.

Time frame:
Baseline and weeks 4, 8 & 12
Reported as:
Least squares mean · mL
Change From Baseline in Mean Volume Voided (MVV) Per Micturition
mLCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 415.06 ± 1.5511.20 ± 1.5514.99 ± 1.55
Week 825.21 ± 1.8914.02 ± 1.8721.08 ± 1.86
Week 1229.54 ± 2.0617.16 ± 2.0820.99 ± 2.04
EoT28.05 ± 1.9716.52 ± 1.9720.30 ± 1.97
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.078 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: 3.86 · 95% CI -0.43 to 8.16
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: 11.19 · 95% CI 5.98 to 16.40
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: 12.38 · 95% CI 6.65 to 18.12
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: 11.52 · 95% CI 6.06 to 16.99
SecondaryChange From Baseline to EoT in Corrected Micturition Frequency (CMF)

CMF was defined as the mean number of micturitions per 24 hours that participants would have at EoT if their fluid intake had remained unchanged since baseline. This was calculated by the MVV per Micturition at baseline multiplied by the mean number of micturitions per 24 hours at baseline divided by the MVV per micturition at EoT.

Time frame:
Baseline and EoT (up to 12 weeks)
Reported as:
Least squares mean · micturitions
Change From Baseline to EoT in Corrected Micturition Frequency (CMF)
micturitionsCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Change From Baseline to EoT in Corrected Micturition Frequency (CMF)-0.96 ± 0.10-0.52 ± 0.10-0.71 ± 0.10
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.003 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.44 · 95% CI -0.73 to -0.16
SecondaryChange From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours

UI was defined as the complaint of involuntary urine leakage accompanied by or immediately preceded by urgency. UI was measured using the Patient Perception of Intensity of Urgency Scale (PPIUS), a patient reported outcome validated 5-point categorical scale rating the degree of associated urinary urgency severity (0=No urgency, I felt no need to empty my bladder, but did so for other reasons. 1=Mild, I could postpone voiding as long as necessary, without fear of wetting myself. 2= Moderate, I could postpone voiding for a short while, without fear of wetting myself. 3=Severe, I could not postpone voiding, but had to rush to the toilet in order not to wet myself. 4=Urgency incontinence, I leaked before arriving to the toilet). One urgency incontinence episode was counted for each record of the diary in which the following occurred: incontinence episode or 'both' was recorded \& severity of urinary urgency recorded was 3 or 4.

Time frame:
Baseline and weeks 4, 8 & 12
Reported as:
Least squares mean · UI episodes
Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours
UI episodesCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 4-1.26 ± 0.07-0.91 ± 0.07-1.14 ± 0.07
Week 8-1.70 ± 0.07-1.25 ± 0.07-1.45 ± 0.07
Week 12-1.84 ± 0.07-1.58 ± 0.07-1.62 ± 0.07
EoT-1.82 ± 0.07-1.54 ± 0.07-1.63 ± 0.07
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · stratified rank ANCOVA · p = <0.001 (P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.35 · 95% CI -0.54 to -0.17
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · stratified rank ANCOVA · p = <0.001 (P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.45 · 95% CI -0.65 to -0.25
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · stratified rank ANCOVA · p = =0.004 (P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.26 · 95% CI -0.47 to -0.05
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · stratified rank ANCOVA · p = =0.003 (P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.27 · 95% CI -0.47 to -0.07
SecondaryNumber of UI Episodes Reported During the 3-Day Diary

Number of UI episodes was calculated using the number of UI episodes recorded on valid diary days during the 3-day micturition diary period. NOTE: Only urgency incontinence episodes recorded on a valid diary day were counted.

Time frame:
Weeks 4, 8 and 12
Reported as:
Mean · UI episodes
Number of UI Episodes Reported During the 3-Day Diary
UI episodesCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 44.96 ± 0.275.86 ± 0.295.50 ± 0.30
Week 83.55 ± 0.254.76 ± 0.274.50 ± 0.30
Week 123.10 ± 0.243.78 ± 0.253.91 ± 0.30
EoT3.33 ± 0.244.00 ± 0.253.96 ± 0.29
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Mixed Effects Poisson · p = =0.003 (p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.) · Rate ratio: 0.85 · 95% CI 0.76 to 0.94
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Mixed Effects Poisson · p = <0.001 (p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.) · Rate ratio: 0.74 · 95% CI 0.63 to 0.86
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Mixed Effects Poisson · p = =0.038 (p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.) · Rate ratio: 0.83 · 95% CI 0.69 to 0.99
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Mixed Effects Poisson · p = =0.022 (p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.) · Rate ratio: 0.82 · 95% CI 0.69 to 0.97
SecondaryChange From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours

An urgency episode was defined as the complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes (severity of 3 or 4) per 24 hours was defined as the average number of times a participant recorded an urgency episode (severity of 3 or 4) with or without incontinence per day during the 3-day micturition diary period. Measured using the PPIUS scale. This was calculated using the sum of each record with an urgency episode (severity of 3 or 4) recorded on a valid diary day divided by the number of valid diary days during the 3-day micturition diary period.

Time frame:
Baseline and weeks 4, 8 & 12
Reported as:
Least squares mean · urgency episodes
Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
urgency episodesCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 4-1.84 ± 0.09-1.39 ± 0.09-1.74 ± 0.10
Week 8-2.64 ± 0.10-2.00 ± 0.10-2.29 ± 0.10
Week 12-2.97 ± 0.11-2.44 ± 0.11-2.55 ± 0.11
EoT-2.95 ± 0.10-2.41 ± 0.10-2.54 ± 0.11
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.45 · 95% CI -0.72 to -0.19
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.64 · 95% CI -0.93 to -0.35
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.52 · 95% CI -0.82 to -0.22
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.54 · 95% CI -0.83 to -0.25
SecondaryChange From Baseline in Mean Number of Pads Per 24 Hours

The mean number of pads per 24 hours was defined as the average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. This was calculated using the number of new pads used during valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period.

Time frame:
Baseline and weeks 4, 8 & 12
Reported as:
Least squares mean · pads
Change From Baseline in Mean Number of Pads Per 24 Hours
padsCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 4-1.12 ± 0.07-0.86 ± 0.07-1.04 ± 0.07
Week 8-1.50 ± 0.07-1.17 ± 0.08-1.36 ± 0.08
Week 12-1.65 ± 0.07-1.38 ± 0.07-1.43 ± 0.07
EoT-1.66 ± 0.07-1.35 ± 0.07-1.43 ± 0.07
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.008 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.26 · 95% CI -0.46 to -0.07
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.002 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.34 · 95% CI -0.55 to -0.13
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.006 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.28 · 95% CI -0.47 to -0.08
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.002 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.31 · 95% CI -0.51 to -0.12
SecondaryNumber of Pads Used During the 3-Day Diary

The number of pads used was defined as the number of times a participant recorded a new pad used during the 3-day micturition diary period. This was calculated using the sum of each record with new pad checked. Only records with new pad checked on a valid diary day were counted.

Time frame:
Weeks 4, 8 and 12
Reported as:
Mean · pads
Number of Pads Used During the 3-Day Diary
padsCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 44.80 ± 0.285.69 ± 0.365.41 ± 0.29
Week 83.64 ± 0.244.71 ± 0.374.50 ± 0.29
Week 123.23 ± 0.224.13 ± 0.284.07 ± 0.28
EoT3.29 ± 0.224.27 ± 0.284.17 ± 0.29
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Mixed Effects Poisson · p = =0.545 (p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.) · Rate ratio: 0.97 · 95% CI 0.87 to 1.08
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Mixed Effects Poisson · p = =0.010 (p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.) · Rate ratio: 0.82 · 95% CI 0.70 to 0.95
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Mixed Effects Poisson · p = =0.007 (p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.) · Rate ratio: 0.79 · 95% CI 0.67 to 0.94
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Mixed Effects Poisson · p = =0.003 (p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.) · Rate ratio: 0.78 · 95% CI 0.66 to 0.92
SecondaryChange From Baseline in Mean Number of Nocturia Episodes

Mean number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) while sleeping during the 3-day diary period, divided by the number of valid diary days during the diary period. Night time episode of incontinence only was not considered a nocturia episode. Nocturia episodes were counted for each micturition record which occurred between the date/time of going to bed with intention to sleep and the date/time of getting up with intention to stay awake on a valid diary day \& which was accompanied by a sleep interruption. Nocturia only determined for those who were not night-shift workers.

Time frame:
Baseline and weeks 4, 8 & 12
Reported as:
Least squares mean · nocturia episodes
Change From Baseline in Mean Number of Nocturia Episodes
nocturia episodesCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 4-0.28 ± 0.03-0.27 ± 0.03-0.29 ± 0.03
Week 8-0.37 ± 0.03-0.35 ± 0.03-0.37 ± 0.03
Week 12-0.46 ± 0.03-0.38 ± 0.03-0.41 ± 0.03
EoT-0.43 ± 0.03-0.37 ± 0.03-0.41 ± 0.03
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.836 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.01 · 95% CI -0.10 to 0.08
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.617 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.02 · 95% CI -0.12 to 0.07
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.134 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.07 · 95% CI -0.17 to 0.02
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.174 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.) · Ls means: -0.06 · 95% CI -0.16 to 0.03
SecondaryNumber of Nocturia Episodes Reported Over 3-Day Diary

The number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) during sleeping time during the 3-day micturition diary period. This was calculated using the sum of each nocturia episode recorded on valid diary days during the 3-day micturition diary period.

Time frame:
Weeks 4, 8 and 12
Reported as:
Mean · nocturia episodes
Number of Nocturia Episodes Reported Over 3-Day Diary
nocturia episodesCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 43.63 ± 0.123.59 ± 0.123.58 ± 0.12
Week 83.33 ± 0.123.35 ± 0.123.32 ± 0.12
Week 123.12 ± 0.133.26 ± 0.123.23 ± 0.12
EoT3.16 ± 0.123.28 ± 0.113.19 ± 0.12
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Mixed Effects Poisson · p = =0.993 (p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.) · Rate ratio: 1.00 · 95% CI 0.93 to 1.08
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Mixed Effects Poisson · p = =0.736 (p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.) · Rate ratio: 0.99 · 95% CI 0.90 to 1.07
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Mixed Effects Poisson · p = =0.121 (p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.) · Rate ratio: 0.93 · 95% CI 0.85 to 1.02
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Mixed Effects Poisson · p = =0.172 (p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.) · Rate ratio: 0.94 · 95% CI 0.86 to 1.03
SecondaryNumber of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility

The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

Time frame:
Baseline and EoT (up to 12 weeks)
Reported as:
Number · participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility
participantsCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
No problems -> no problems409370374
No problems -> slight problems333536
No problems -> moderate problems141111
No problems -> severe problems074
No problems -> extreme problems010
No problems -> no data245
Slight problems -> no problems525860
Slight problems -> slight problems434640
Slight problems -> moderate problems152816
Slight problems -> severe problems133
Slight problems -> extreme problems000
Slight problems -> no data200
Moderate problems -> no problems243625
Moderate problems -> slight problems251823
Moderate problems -> moderate problems282840
Moderate problems -> severe problems237
Moderate problems -> extreme problems010
Moderate problems -> no data100
Severe problems -> no problems782
Severe problems -> slight problems677
Severe problems -> moderate problems171111
Severe problems -> severe problems121014
Severe problems -> extreme problems000
Severe problems -> no data110
Extreme problems -> no problems322
Extreme problems -> slight problems100
Extreme problems -> moderate problems111
Extreme problems -> severe problems100
Extreme problems -> extreme problems000
Extreme problems -> no data000
No data -> no problems4913
No data -> slight problems241
No data -> moderate problems033
No data -> severe problems000
No data -> extreme problems000
No data -> no data100
SecondaryNumber of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care

The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

Time frame:
Baseline and EoT (up to 12 weeks)
Reported as:
Number · participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care
participantsCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
No problems -> no problems548541548
No problems -> slight problems282625
No problems -> moderate problems0147
No problems -> severe problems302
No problems -> extreme problems000
No problems -> no data654
Slight problems -> no problems372532
Slight problems -> slight problems232422
Slight problems -> moderate problems979
Slight problems -> severe problems100
Slight problems -> extreme problems000
Slight problems -> no data001
Moderate problems -> no problems12167
Moderate problems -> slight problems995
Moderate problems -> moderate problems11712
Moderate problems -> severe problems022
Moderate problems -> extreme problems000
Moderate problems -> no data000
Severe problems -> no problems750
Severe problems -> slight problems222
Severe problems -> moderate problems212
Severe problems -> severe problems141
Severe problems -> extreme problems000
Severe problems -> no data000
Extreme problems -> no problems000
Extreme problems -> slight problems010
Extreme problems -> moderate problems000
Extreme problems -> severe problems100
Extreme problems -> extreme problems000
Extreme problems -> no data000
No data -> no problems61417
No data -> slight problems020
No data -> moderate problems000
No data -> severe problems000
No data -> extreme problems000
No data -> no data100
SecondaryNumber of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities

The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

Time frame:
Baseline and EoT (up to 12 weeks)
Reported as:
Number · participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities
participantsCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
No problems -> no problems397384379
No problems -> slight problems383042
No problems -> moderate problems121911
No problems -> severe problems141
No problems -> extreme problems001
No problems -> no data433
Slight problems -> no problems758178
Slight problems -> slight problems464537
Slight problems -> moderate problems121615
Slight problems -> severe problems113
Slight problems -> extreme problems010
Slight problems -> no data012
Moderate problems -> no problems293525
Moderate problems -> slight problems222028
Moderate problems -> moderate problems221821
Moderate problems -> severe problems334
Moderate problems -> extreme problems100
Moderate problems -> no data210
Severe problems -> no problems9812
Severe problems -> slight problems751
Severe problems -> moderate problems769
Severe problems -> severe problems579
Severe problems -> extreme problems000
Severe problems -> no data000
Extreme problems -> no problems200
Extreme problems -> slight problems100
Extreme problems -> moderate problems310
Extreme problems -> severe problems100
Extreme problems -> extreme problems000
Extreme problems -> no data000
No data -> no problems51115
No data -> slight problems141
No data -> moderate problems011
No data -> severe problems000
No data -> extreme problems000
No data -> no data100
SecondaryNumber of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort

The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

Time frame:
Baseline and EoT (up to 12 weeks)
Reported as:
Number · participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort
participantsCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
No pain -> no pain299290283
No pain -> slight pain456251
No pain -> moderate pain121417
No pain -> severe pain392
No pain -> extreme pain001
No pain -> no data443
Slight pain -> no pain798281
Slight pain -> slight pain586455
Slight pain -> moderate pain281731
Slight pain -> severe pain025
Slight pain -> extreme pain120
Slight pain -> no data002
Moderate pain -> no pain393621
Moderate pain -> slight pain373639
Moderate pain -> moderate pain343039
Moderate pain -> severe pain748
Moderate pain -> extreme pain010
Moderate pain -> no data210
Severe pain -> no pain7410
Severe pain -> slight pain1274
Severe pain -> moderate pain111616
Severe pain -> severe pain1049
Severe pain -> extreme pain011
Severe pain -> no data000
Extreme pain -> no pain410
Extreme pain -> slight pain011
Extreme pain -> moderate pain101
Extreme pain -> severe pain611
Extreme pain -> extreme pain100
Extreme pain -> no data000
No data -> no pain4811
No data -> slight pain134
No data -> moderate pain152
No data -> severe pain000
No data -> extreme pain000
No data -> no data100
SecondaryNumber of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression

The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

Time frame:
Baseline and EoT (up to 12 weeks)
Reported as:
Number · participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression
participantsCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Not anxious -> not anxious322300307
Not anxious -> slightly anxious433943
Not anxious -> moderately anxious111715
Not anxious -> severely anxious223
Not anxious-> extremely anxious000
Not anxious -> no data433
Slightly anxious -> not anxious1079990
Slightly anxious -> slightly anxious566069
Slightly anxious -> moderately anxious131123
Slightly anxious -> severely anxious122
Slightly anxious -> extremely anxious000
Slightly anxious -> no data122
Moderately anxious -> not anxious363834
Moderately anxious -> slightly anxious364033
Moderately anxious -> moderately anxious222617
Moderately anxious -> severely anxious371
Moderately anxious -> extremely anxious031
Moderately anxious -> no data000
Severely anxious -> not anxious1088
Severely anxious -> slightly anxious955
Severely anxious -> moderately anxious6611
Severely anxious -> severely anxious587
Severely anxious -> extremely anxious030
Severely anxious -> no data000
Extremely anxious -> not anxious141
Extremely anxious -> slightly anxious211
Extremely anxious -> moderately anxious423
Extremely anxious -> severely anxious411
Extremely anxious -> extremely anxious121
Extremely anxious -> no data100
No data -> not anxious51311
No data -> slightly anxious025
No data -> moderately anxious111
No data -> severely anxious000
No data -> extremely anxious000
No data -> no data100
SecondaryChange From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity).

Time frame:
Baseline and weeks 4, 8 & 12
Reported as:
Least squares mean · units on a scale
Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score
units on a scaleCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 4-16.68 ± 0.65-13.79 ± 0.65-15.82 ± 0.65
Week 8-22.86 ± 0.68-18.36 ± 0.69-19.34 ± 0.69
Week 12-27.90 ± 0.71-22.31 ± 0.71-24.09 ± 0.71
EoT-26.89 ± 0.69-21.93 ± 0.70-23.59 ± 0.70
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.002 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: -2.89 · 95% CI -4.68 to -1.10
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: -4.50 · 95% CI -6.40 to -2.60
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: -5.59 · 95% CI -7.56 to -3.62
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: -4.96 · 95% CI -6.88 to -3.04
SecondaryChange From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

Time frame:
Baseline and weeks 4, 8 & 12
Reported as:
Least squares mean · units on a scale
Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score
units on a scaleCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 412.95 ± 0.5911.03 ± 0.5912.44 ± 0.59
Week 817.58 ± 0.6315.26 ± 0.6314.60 ± 0.64
Week 1221.40 ± 0.6617.91 ± 0.6717.72 ± 0.66
EoT20.78 ± 0.6517.63 ± 0.6517.40 ± 0.65
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.021 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 1.92 · 95% CI 0.29 to 3.55
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.010 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 2.31 · 95% CI 0.56 to 4.06
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 3.49 · 95% CI 1.65 to 5.33
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 3.15 · 95% CI 1.35 to 4.95
SecondaryChange From Baseline in OAB-q HRQL Subscale Score: Coping

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

Time frame:
Baseline and weeks 4, 8 & 12
Reported as:
Least squares mean · units on a scale
Change From Baseline in OAB-q HRQL Subscale Score: Coping
units on a scaleCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 415.17 ± 0.6812.27 ± 0.6814.25 ± 0.68
Week 820.82 ± 0.7417.47 ± 0.7416.87 ± 0.74
Week 1225.16 ± 0.7820.45 ± 0.7820.20 ± 0.78
EoT24.48 ± 0.7520.19 ± 0.7619.90 ± 0.76
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.003 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 2.90 · 95% CI 1.02 to 4.78
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 3.35 · 95% CI 1.29 to 5.40
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 4.71 · 95% CI 2.55 to 6.87
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 4.29 · 95% CI 2.20 to 6.39
SecondaryChange From Baseline in OAB-q HRQL Subscale Score: Concern

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

Time frame:
Baseline and weeks 4, 8 & 12
Reported as:
Least squares mean · units on a scale
Change From Baseline in OAB-q HRQL Subscale Score: Concern
units on a scaleCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 413.79 ± 0.6811.85 ± 0.6813.82 ± 0.69
Week 818.87 ± 0.7016.36 ± 0.7115.88 ± 0.71
Week 1222.85 ± 0.7419.24 ± 0.7519.67 ± 0.74
Week EoT22.28 ± 0.7219.00 ± 0.7319.28 ± 0.73
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.044 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 1.94 · 95% CI 0.05 to 3.83
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.012 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 2.50 · 95% CI 0.55 to 4.46
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 3.61 · 95% CI 1.54 to 5.67
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 3.28 · 95% CI 1.27 to 5.29
SecondaryChange From Baseline in OAB-q HRQL Subscale Score: Sleep

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

Time frame:
Baseline and weeks 4, 8 & 12
Reported as:
Least squares mean · units on a scale
Change From Baseline in OAB-q HRQL Subscale Score: Sleep
units on a scaleCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 411.58 ± 0.6811.04 ± 0.6811.16 ± 0.69
Week 816.18 ± 0.7114.57 ± 0.7113.72 ± 0.71
Week 1220.00 ± 0.7417.74 ± 0.7416.84 ± 0.74
Week EoT19.16 ± 0.7217.30 ± 0.7316.55 ± 0.73
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.575 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 0.54 · 95% CI -1.35 to 2.43
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.109 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 1.61 · 95% CI -0.36 to 3.58
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.032 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 2.26 · 95% CI 0.20 to 4.32
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.069 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 1.86 · 95% CI -0.15 to 3.87
SecondaryChange From Baseline in OAB-q HRQL Subscale Score: Social Interaction

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

Time frame:
Baseline and weeks 4, 8 & 12
Reported as:
Least squares mean · units on a scale
Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction
units on a scaleCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 49.58 ± 0.597.85 ± 0.598.95 ± 0.59
Week 811.93 ± 0.6010.84 ± 0.6010.16 ± 0.60
Week 1214.70 ± 0.6112.08 ± 0.6111.98 ± 0.61
EoT14.39 ± 0.6011.91 ± 0.6011.72 ± 0.61
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.037 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 1.73 · 95% CI 0.10 to 3.36
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.199 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 1.09 · 95% CI -0.57 to 2.76
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.003 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 2.62 · 95% CI 0.92 to 4.31
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.004 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 2.48 · 95% CI 0.81 to 4.15
SecondaryChange From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score

The TS-VAS rated participant satisfaction with treatment on a scale from 0 (No, not at all) to 10 (Yes, completely).

Time frame:
Baseline and weeks 4, 8 & 12
Reported as:
Least squares mean · units on a scale
Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score
units on a scaleCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 41.2 ± 0.10.8 ± 0.11.1 ± 0.1
Week 81.5 ± 0.11.2 ± 0.11.3 ± 0.1
Week 121.9 ± 0.11.4 ± 0.11.6 ± 0.1
EoT1.8 ± 0.11.4 ± 0.11.6 ± 0.1
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 0.4 · 95% CI 0.2 to 0.6
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.019 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 0.3 · 95% CI 0.0 to 0.5
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 0.5 · 95% CI 0.3 to 0.7
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = =0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: 0.4 · 95% CI 0.2 to 0.6
SecondaryChange From Baseline in Patient Perception Bladder Control (PPBC) Score

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. PPBC score: 1-no problem, 2- some very minor problems, 3-some minor problems, 4-moderate problems, 5-severe problems, 6-many severe problems.

Time frame:
Baseline and weeks 4, 8 & 12
Reported as:
Least squares mean · units on a scale
Change From Baseline in Patient Perception Bladder Control (PPBC) Score
units on a scaleCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 4-0.9 ± 0.0-0.6 ± 0.0-0.7 ± 0.0
Week 8-1.2 ± 0.0-1.0 ± 0.0-1.0 ± 0.0
Week 12-1.5 ± 0.0-1.2 ± 0.0-1.3 ± 0.0
EoT-1.5 ± 0.0-1.2 ± 0.0-1.3 ± 0.0
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: -0.2 · 95% CI -0.4 to -0.1
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: -0.2 · 95% CI -0.4 to -0.1
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: -0.3 · 95% CI -0.4 to -0.2
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · ANCOVA · p = <0.001 (P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.) · Ls means: -0.3 · 95% CI -0.4 to -0.1
SecondaryNumber of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC)

The PGIC was a 2-part questionnaire, assessing both the change in the participant's overall condition (Patient Impression in General Health (PIBS)) and change in bladder condition since the start of the study (Patient Impression in General Health (PIGH)) (from very much worse to very much improved). The CGIC was a single questionnaire assessing the participant's change in bladder condition since the beginning of the study (Clinician Impression in Bladder Symptoms (CIBS)).

Time frame:
End of treatment (up to 12 weeks)
Reported as:
Number · participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC)
participantsCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
PIBS Very Much Improved227152171
PIBS Much Improved257264284
PIBS Minimally Improved135170152
PIBS No Change255556
PIBS Minimally Worse7114
PIBS Much Worse446
PIBS Very Much Worse011
PIGH Very Much Improved144104108
PIGH Much Improved239236244
PIGH Minimally Improved143147146
PIGH No Change113142160
PIGH Minimally Worse142310
PIGH Much Worse144
PIGH Very Much Worse112
CIBS Very Much Improved184118141
CIBS Much Improved311316329
CIBS Minimally Improved141164155
CIBS No Change235640
CIBS Minimally Worse485
CIBS Much Worse435
CIBS Very Much Worse334
SecondaryPercentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours

Incontinence was defined as any involuntary leakage of urine.

Time frame:
Weeks 4, 8 and 12
Reported as:
Number · percentage of participants
Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
percentage of participantsCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 452.543.349.0
Week 866.957.661.8
Week 1272.464.066.9
EoT71.263.166.6
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = <0.001 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.48 · 95% CI 1.19 to 1.84
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = <0.001 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.57 · 95% CI 1.25 to 1.98
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = =0.001 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.54 · 95% CI 1.21 to 1.95
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = <0.001 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.51 · 95% CI 1.20 to 1.90
SecondaryPercentage of Participants With Zero Incontinence Episodes Postbaseline

Incontinence was defined as any involuntary leakage of urine.

Time frame:
Weeks 4, 8 and 12
Reported as:
Number · percentage of participants
Percentage of Participants With Zero Incontinence Episodes Postbaseline
percentage of participantsCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 423.520.022.1
Week 840.431.634.3
Week 1247.339.540.7
EoT46.037.940.2
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = =0.119 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.24 · 95% CI 0.95 to 1.63
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = <0.001 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.56 · 95% CI 1.23 to 1.98
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = =0.002 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.44 · 95% CI 1.14 to 1.82
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = =0.001 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.47 · 95% CI 1.17 to 1.84
SecondaryPercentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline

Micturitions were defined as voluntary urinations (excluding incontinence only episodes).

Time frame:
Weeks 4, 8 and 12
Reported as:
Number · percentage of participants
Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline
percentage of participantsCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 421.018.720.2
Week 828.122.426.3
Week 1231.424.828.0
EoT30.225.027.7
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = =0.305 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.15 · 95% CI 0.88 to 1.50
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = =0.014 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.37 · 95% CI 1.06 to 1.76
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = =0.012 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.37 · 95% CI 1.07 to 1.76
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = =0.036 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.29 · 95% CI 1.02 to 1.64
SecondaryPercentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity).

Time frame:
Weeks 4, 8 and 12
Reported as:
Number · percentage of participants
Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score
percentage of participantsCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 467.958.261.9
Week 877.266.469.1
Week 1283.572.175.4
EoT81.771.774.6
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = =0.001 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.49 · 95% CI 1.18 to 1.88
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = <0.001 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.69 · 95% CI 1.31 to 2.18
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = <0.001 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.96 · 95% CI 1.47 to 2.61
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = <0.001 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.75 · 95% CI 1.34 to 2.30
SecondaryPercentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score

HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

Time frame:
Weeks 4, 8 and 12
Reported as:
Number · percentage of participants
Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score
percentage of participantsCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 452.644.548.1
Week 863.654.853.8
Week 1270.560.860.4
EoT68.660.660.1
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = =0.003 (p\<0.05 indicates superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.44 · 95% CI 1.14 to 1.82
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = =0.001 (p\<0.05 indicates superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.51 · 95% CI 1.18 to 1.93
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = <0.001 (p\<0.05 indicates superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.64 · 95% CI 1.27 to 2.13
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = =0.001 (p\<0.05 indicates superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.50 · 95% CI 1.17 to 1.91
SecondaryPercentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC

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.

Time frame:
Weeks 4, 8 and 12
Reported as:
Number · percentage of participants
Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC
percentage of participantsCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 461.152.156.3
Week 870.162.164.6
Week 1277.970.472.7
EoT76.569.571.9
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = =0.003 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.42 · 95% CI 1.13 to 1.79
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = =0.004 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.44 · 95% CI 1.12 to 1.84
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = =0.003 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.50 · 95% CI 1.15 to 1.96
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = =0.006 (p\<0.05 indicated superiority in favor of treatment group with highest response.) · Odds ratio (or): 1.43 · 95% CI 1.11 to 1.84
SecondaryPercentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC

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.

Time frame:
Weeks 4, 8 and 12
Reported as:
Number · percentage of participants
Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC
percentage of participantsCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 426.621.621.6
Week 839.531.531.8
Week 1251.839.843.8
EoT49.839.143.2
Statistical analysis
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = =0.065 · Odds ratio (or): 1.28 · 95% CI 0.99 to 1.66
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = =0.004 · Odds ratio (or): 1.41 · 95% CI 1.11 to 1.79
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = <0.001 · Odds ratio (or): 1.64 · 95% CI 1.30 to 2.07
  • Combination (Solifenacin + Mirabegron) vs Solifenacin 5 mg · Regression, Logistic · p = <0.001 · Odds ratio (or): 1.55 · 95% CI 1.24 to 1.94
SecondaryNumber of Participants With Adverse Events (AEs)

AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures \& which does not necessarily have a causal relationship with this treatment. Treatment-Emergent Adverse Event (TEAE) referred to an adverse event which started or worsened in the period from first double-blind medication intake until 30 days after the last double-blind medication intake.

Time frame:
From first dose of double blind treatment until 30 days after last dose (up to 16 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs)
ParticipantsCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
AEs260241283
Drug-related AEs141125161
Serious Adverse Events (SAEs)131015
Drug-related SAEs103
AEs Leading to Perm. Disc. of Study Drug111111
Drug-related AEs Leading to Perm. Disc. of Drug9109
Deaths000
SecondaryChange From Baseline in Post Void Residual (PVR) Volume

PVR Volume was assessed by bladder scan.

Time frame:
Baseline and weeks 4, 8 & 12
Reported as:
Mean · mL
Change From Baseline in Post Void Residual (PVR) Volume
mLCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Week 41.545 ± 40.3132.821 ± 38.5887.308 ± 72.122
Week 82.245 ± 38.3471.117 ± 36.4707.232 ± 60.096
Week 126.356 ± 51.0672.337 ± 42.1476.552 ± 48.505
EoT5.478 ± 51.5953.046 ± 43.4997.354 ± 54.121

Adverse events

Collected over From first dose of double blind treatment until 30 days after last dose (up to 16 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Combination (Solifenacin + Mirabegron)—13/725 (1.8%)43/725 (5.9%)
Solifenacin 5 mg—10/728 (1.4%)41/728 (5.6%)
Solifenacin 10 mg—15/719 (2.1%)68/719 (9.5%)
Most frequent serious events
Showing 10 of 41
Most frequent serious events
EventCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Acute myocardial infarctionCardiac disorders0/7250/7281/719
Abdominal painGastrointestinal disorders0/7250/7281/719
Non-cardiac chest painGeneral disorders1/7250/7281/719
Hepatic painHepatobiliary disorders0/7250/7281/719
Liver disorderHepatobiliary disorders0/7250/7281/719
AppendicitisInfections and infestations1/7251/7281/719
Femur fractureInjury, poisoning and procedural complications0/7250/7281/719
ArthroscopyInvestigations0/7250/7281/719
ColonoscopyInvestigations0/7250/7281/719
Fracture painMusculoskeletal and connective tissue disorders0/7250/7281/719
Most frequent other events
Most frequent other events
EventCombination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mg
Dry mouthGastrointestinal disorders43/72541/72868/719

Baseline characteristics

Age, Continuous
Age, Continuous(Year)Combination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mgTotal
Mean58.2 ± 13.156.9 ± 13.557.4 ± 13.257.5 ± 13.3
Sex: Female, Male
Sex: Female, Male(Participants)Combination (Solifenacin + Mirabegron)Solifenacin 5 mgSolifenacin 10 mgTotal
Female6046046001808
Male123124119366
08

Study locations

219 sites
  • Genova Clinical Research
    Tucson, Arizona 85704, United States
  • Associated Pharmaceutical Research Center, Inc.
    Buena Park, California 90620, United States
  • The American Institute of Research
    Los Angeles, California 90017, United States
  • Bayview Research Group
    Valley Village, California 91607, United States
  • Meridien Research
    Brooksville, Florida 33016, United States
  • Innovative Research of West FL
    Clearwater, Florida 33756, United States
  • Best Quality Research Inc.
    Hialeah, Florida 33016, United States
  • Palmetto Professional Research
    Hialeah, Florida 33016, United States
  • Urology Center of Central Florida
    Kissimmee, Florida 34741, United States
  • Meridien Research
    Tampa, Florida 33606, United States
  • Stedman Clinical Trials
    Tampa, Florida 33613, United States
  • Private Practice
    West Palm Beach, Florida 33407, United States
  • Meridian Clinical Research, LLC
    Savannah, Georgia 31406, United States
  • Herman Clinical Research
    Suwanee, Georgia 30024, United States
  • North Idaho Urology
    Coeur d'Alene, Idaho 83814, United States
  • First Urology, PSC
    Jeffersonville, Indiana 47130, United States
  • Deaconess Gateway Health Center
    Newburgh, Indiana 47630, United States
  • MedStar Health Research Institute
    Hyattsville, Maryland 20782, United States
  • Bay State Clinical Trials, Inc.
    Watertown, Massachusetts 02472, United States
  • Beyer Research
    Kalamazoo, Michigan 49009, United States
  • Quality Clinical Research
    Omaha, Nebraska 68114, United States
  • Albuquerque Clinical Trials, Inc.
    Albuquerque, New Mexico 87102, United States
  • Brooklyn Urology Research Group
    Brooklyn, New York 11215, United States
  • Advanced Urology Centers of New York
    Garden City, New York 11530, United States
  • Premier Medical Group of the Hudson Valley PC
    Kingston, New York 12401, United States
  • Premier Medical Group of the Hudson Valley PC
    Poughkeepsie, New York 12601, United States
  • PMG Research of Raleigh, dba PMG Research of Cary
    Cary, North Carolina 27518, United States
  • Alliance Urology Specialists
    Greensboro, North Carolina 27403, United States
  • Wake Research Associates LLC
    Raleigh, North Carolina 27612, United States
  • PMG Research of Winston-Salem, LLC
    Winston-Salem, North Carolina 27103, United States
  • The Urology Group
    Cincinnati, Ohio 45212, United States
  • Providence Health Partners
    Dayton, Ohio 45439, United States
  • The Clinical Trial Center
    Jenkintown, Pennsylvania 19046, United States
  • Health Concepts
    Rapid City, South Dakota 57702, United States
  • Jean Brown Research
    Salt Lake City, Utah 84124, United States
  • Alexandria Clinical Research
    Alexandria, Virginia 22304, United States
  • Site: 37402
    Yerevan, Armenia
  • Site: 37403
    Yerevan, Armenia
  • Site: 37405
    Yerevan, Armenia
  • Site: 61006
    Adelaide, Australia
  • Site: 61001
    Kogarah, Sydney, Australia
  • Site: 61016
    Victoria, Australia
  • Site: 43008
    Graz, Austria
  • Site: 43001
    Innsbruck, Austria
  • Site: 43006
    Innsbruck, Austria
  • Site: 43007
    Linz, Austria
  • Site: 43002
    Vienna, Austria
  • Site: 43004
    Vienna, Austria
  • Site: 43005
    Vienna, Austria
  • Site: 43010
    Vienna, Austria
  • Site: 43011
    Vienna, Austria
  • Site: 43012
    Vienna, Austria
  • Site: 43003
    Wels, Austria
  • Site: 32007
    Anderlecht, Belgium
  • Site: 32013
    Deurne, Belgium
  • Site: 32009
    Edegem, Belgium
  • Site: 32003
    Gent, Belgium
  • Site: 32005
    Gent, Belgium
  • Site: 32015
    Kortrijk, Belgium
  • Site: 32008
    Liege, Belgium
  • Site: 32014
    Roeselare, Belgium
  • Site: 15001
    Barrie, Canada
  • Site: 15009
    Bathurst, Canada
  • Site: 15006
    Brampton, Canada
  • Site: 15015
    Granby, Canada
  • Site: 15014
    Kelowna, Canada
  • Site: 15007
    Kitchener, Canada
  • Site: 15019
    Sherbrooke, Canada
  • Site: 15012
    Toronto, Canada
  • Site: 15013
    Toronto, Canada
  • Site: 15018
    Victoriaville, Canada
  • Site: 15016
    Victoria, Canada
  • Site: 15047
    Victoria, Canada
  • Site: 42015
    Brno, Czechia
  • Site: 42020
    Melnik, Czechia
  • Site: 42018
    Nachod, Czechia
  • Site: 42004
    Plzen, Czechia
  • Site: 42021
    Plzen, Czechia
  • Site: 42016
    Prague 1, Czechia
  • Site: 42008
    Prague, Czechia
  • Site: 42017
    Praha 2, Czechia
  • Site: 42007
    Praha 4, Czechia
  • Site: 42022
    Praha 4, Czechia
  • Site: 45008
    Aarhus N, Denmark
  • Site: 45003
    Frederiksberg, Denmark
  • Site: 45009
    Herlev, Denmark
  • Site: 45011
    Odense C, Denmark
  • Site: 35804
    Helsinki (hus), Finland
  • Site: 35805
    Tampere, Finland
  • Site: 33018
    Bordeaux Cedex, France
  • Site: 33017
    Marseille, France
  • Site: 99502
    T'bilisi, Georgia
  • Site: 49008
    Bad Ems, Germany
  • Site: 49022
    Berlin, Germany
  • Site: 49021
    Hagenow, Germany
  • Site: 49011
    Halle (Saale), Germany
  • Site: 49004
    Hamburg, Germany
  • Site: 49018
    Henningsdorf, Germany
  • Site: 49009
    Hettstedt, Germany
  • Site: 49017
    Koblenz, Germany

Showing the first 100 of 219 sites across 31 countries. Choose a country and city above to see the rest.

09

References and documents

Publications

  • Gibson W, MacDiarmid S, Huang M, Siddiqui E, Stolzel M, Choudhury N, Drake MJ. Treating Overactive Bladder in Older Patients with a Combination of Mirabegron and Solifenacin: A Prespecified Analysis from the BESIDE Study. Eur Urol Focus. 2017 Dec;3(6):629-638. doi: 10.1016/j.euf.2017.08.008. Epub 2017 Sep 12. PubMed 28916436 ↗
  • Drake MJ, Chapple C, Esen AA, Athanasiou S, Cambronero J, Mitcheson D, Herschorn S, Saleem T, Huang M, Siddiqui E, Stolzel M, Herholdt C, MacDiarmid S; BESIDE study investigators. Efficacy and Safety of Mirabegron Add-on Therapy to Solifenacin in Incontinent Overactive Bladder Patients with an Inadequate Response to Initial 4-Week Solifenacin Monotherapy: A Randomised Double-blind Multicentre Phase 3B Study (BESIDE). Eur Urol. 2016 Jul;70(1):136-145. doi: 10.1016/j.eururo.2016.02.030. Epub 2016 Mar 8. PubMed 26965560 ↗

Individual participant data

Plan to share: Yes — Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

Access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Data sharing details ↗ · www.clinicaltrials.astellas.com

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01908829
Lead sponsor
Astellas Pharma Europe Ltd.
Responsible party
Sponsor
First posted
Jul 26, 2013
Start date
Jul 10, 2013
Primary completion
Nov 24, 2014
Completion
Nov 25, 2014
Results posted
Oct 9, 2017
Last update
Oct 31, 2024

Study contacts

Clinical Study Manager
study director · Astellas Pharma Europe Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Mirabegron · Solifenacin

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Urinary Bladder, Overactive →

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