This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder
Condition: Urinary Bladder Overactive; Urinary Bladder Diseases\Urologic Diseases; Overactive Bladder; Urgency Incontinence
MeSH terms: Urinary Bladder, Overactive; Urologic Diseases; Urinary Bladder Diseases
Intervention: Solifenacin succinate; Mirabegron; Placebo to match solifenacin succinate; Placebo to match mirabegron
Intervention description: Oral tablet; Oral tablet; Oral tablet; Oral tablet
Intervention MeSH terms: Mirabegron; Solifenacin Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3527.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Combination Therapy; Mirabegron; Overactive Bladder; Urgency; Urinary Incontinence; Nocturia; Solifenacin Succinate

Summary:

      The purpose of this study was to examine how well two medicines (solifenacin succinate and
      mirabegron) combined work compared to each medicine alone in the treatment of bladder
      problems.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject was willing and able to complete the micturition diary and questionnaires
             correctly and able to measure his/her vital signs at home at stipulated time points,
             using the device provided by the study personnel, and to adequately record the
             readings;

          -  Subject had symptoms of "wet" OAB (urinary frequency and urgency with incontinence)
             for at least 3 months;

        Exclusion Criteria:

          -  Subject had significant PVR volume (> 150 mL);

          -  Subject had a neurological cause for detrusor overactivity (e.g. neurogenic bladder,
             diabetic neuropathy with autonomic component or bladder involvement, or systemic or
             central neurological disease such as multiple sclerosis and Parkinson's disease with
             autonomic component or bladder involvement). An autonomic component could be inferred
             when autonomic functions were affected, including heart rate, blood pressure,
             perspiration and digestion.

          -  Subject had an indwelling catheter or practices intermittent self catheterization.

          -  Subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis,
             symptomatic bladder stones or any previous or current radiation cystitis.

          -  Subject had received intravesical treatment in the past 12 months with e.g., botulinum
             toxin, resiniferatoxin, capsaicin.

          -  Subject had moderate to severe hepatic impairment

          -  Subject had severe renal impairment

          -  Subject had a clinically significant abnormal ECG

          -  Subject had a concurrent malignancy or history of cancer (except noninvasive skin
             cancer) within the last 5 years prior to screening.

          -  Subject had an average QTcF interval > 450 ms for males or > 470 ms for females based
             on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g.,
             family history of long QT syndrome, hypokalaemia).

          -  Subject had severe hypertension, which is defined as a sitting average systolic blood
             pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.