A Study of the Efficacy and Safety of Vibegron (MK-4618) in Participants With Overactive Bladder (OAB) (MK-4618-008)
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Intervention: Vibegron; Tolterodine ER; Placebo matching vibegron; Placebo matching tolterodine ER
Intervention description: Participants received vibegron oral tablets at dosages of 3 mg, 15 mg, 50 mg, or 100 mg depending on their vibegron arm assignment, taken orally each morning.; Participants received one tolterodine ER 4 mg capsule, taken orally once a day.; Participants received placebo matching vibegron tablets, taken orally each morning.; Participants received placebo matching tolterodine ER capsule, taken orally each morning.
Intervention MeSH terms: Tolterodine Tartrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1395.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Overactive bladder; MK-4618; tolterodine

Summary:

      This is a 2-part study to assess if vibegron (MK-4618) reduces the number of daily urinations
      more effectively than placebo in participants with overactive bladder (OAB). The primary
      hypothesis of the base study is that administration of vibegron demonstrates a dose-related
      reduction, compared with placebo, in average number of daily micturitions in participants
      with OAB after 8 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  If participant is of reproductive potential, must agree to remain abstinent or use (or
             have his/her partner use) 2 acceptable methods of birth control within the projected
             duration of the study

          -  Clinical history of OAB for at least 3 months and meets either the OAB wet or OAB dry
             criteria

          -  Is able to read, understand and complete questionnaires and voiding diaries without
             assistance

          -  Is ambulatory and in good general physical and mental health

          -  No clinically significant electrocardiogram or laboratory abnormality

        Exclusion Criteria:

          -  If female, is currently pregnant or breast-feeding, or expecting to conceive within
             the projected duration of the study

          -  Evidence of diabetes insipidus, uncontrolled hyperglycemia or uncontrolled
             hypercalcemia

          -  Allergy, intolerance, or history of a significant clinical or laboratory adverse
             experience associated with any of the active or inactive components of tolterodine ER
             or vibegron (MK-4618) formulation; or has a history or active diagnosis of any
             condition contraindicated in the tolterodine ER prescribing label

          -  Has lower urinary tract pathology that could be responsible for urgency, frequency, or
             incontinence

          -  History of injury, surgery, or neurodegenerative diseases (e.g., multiple sclerosis)
             that could affect the lower urinary tract or its nerve supply

          -  History of continual urine leakage

          -  Surgery to correct stress urinary incontinence or pelvic organ prolapse within 6
             months

          -  Known history of elevated postvoid residual

          -  Bladder training or electrostimulation within 2 weeks or is planning to initiate
             either procedure during the study

          -  Active or recurrent (>6 episodes per year) urinary tract infections

          -  Current hematuria

          -  Required use of an indwelling catheter or requires intermittent catheterization

          -  History of fecal incontinence