A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.
Condition: Urologic Diseases; Urinary Bladder, Overactive; Urinary Bladder Diseases
MeSH terms: Urinary Bladder, Overactive; Urologic Diseases; Urinary Bladder Diseases
Intervention: Mirabegron; Solifenacin succinate
Intervention description: 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: 1887.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vesitrim; Frequency; Urgency; Urgency incontinence; Urinary incontinence; Overactive Bladder (OAB); Micturition; Mirabegron; YM178; Vesicare; Solifenacin

Summary:

      The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50
      mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied
      with their treatment due to lack of efficacy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is willing and able to complete the micturition diary and questionnaires
             correctly

          -  Subject has symptoms of OAB (urinary frequency and urgency with or without urgency
             incontinence) for at least 3 months

          -  Subject is currently or has previously received at least one antimuscarinic agent
             intended to treat their OAB. The last antimuscarinic must have been taken for at least
             4 weeks and taken within 6 months prior to the Screening Visit

        Exclusion Criteria:

          -  Female subject is breastfeeding, pregnant, intends to become pregnant during the
             study, or of childbearing potential is sexually active and not practicing a highly
             reliable method of birth control

          -  Subject has neurogenic bladder

          -  Subject has significant stress incontinence or mixed stress/urgency incontinence where
             stress is the predominant factor as determined by the investigator (for female
             subjects confirmed by a cough provocation test)

          -  Subject has an indwelling catheter or practices intermittent self-catheterization

          -  Subject has diabetic neuropathy

          -  Subject has evidence of a symptomatic urinary tract infection, chronic inflammation
             such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or
             previous or current malignant disease of the pelvic organs

          -  Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe
             ulcerative colitis, toxic megacolon, myasthenia gravis or any other medical condition
             which makes the use of anticholinergics contraindicated

          -  The subject is currently receiving or has a history of treatment with intravesical
             botulinum toxin (cosmetic use is acceptable) or resiniferatoxin within 9 months prior
             to screening

          -  Subject receives non-drug treatment including electro-stimulation therapy (with the
             exception of a bladder training program or pelvic floor exercises which started more
             than 30 days prior to screening)

          -  Subject has moderate to severe hepatic impairment

          -  Subject has severe renal impairment or end stage renal disease

          -  Subject has severe uncontrolled hypertension

          -  Subject has a clinically significant abnormal electrocardiogram (ECG) or has a known
             history of QT prolongation or currently taking medication known to prolong the QT
             interval

          -  Subject has a known or suspected hypersensitivity to solifenacin, mirabegron or any of
             the inactive ingredients

          -  Subject has a concurrent malignancy or history of cancer (except noninvasive skin
             cancer) within the last 5 years prior to screening

          -  Subject has been treated with an experimental device within 30 days or received an
             experimental agent within the longer of 30 days or five half-lives

          -  Subject is using prohibited medications which cannot be stopped safely at the
             Screening Visit. Subject is excluded if using restricted medications not meeting
             protocol-specified criteria

          -  Subject's last antimuscarinic treatment was solifenacin