A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB)

Inclusion Criteria

• Has a history of OAB for at least 3 months prior to the Screening Visit.
• Meets either the OAB Wet or OAB Dry criteria.

Exclusion Criteria

Urology Medical History

• Patient had an average total daily urine volume > 3000 mL in the past 6 months or during the 14-day Run-in Period.
• Has lower urinary tract pathology that could, in the opinion of the Investigator, be responsible for urgency, frequency, or incontinence.
• Has a history of surgery to correct stress urinary incontinence, pelvic organ prolapse, or procedural treatments for BPH within 6 months of Screening.
• Has current history or evidence of Stage 2 or greater pelvic organ prolapse (prolapse extends beyond the hymenal ring).
• Patient is currently using a pessary for the treatment of pelvic organ prolapse.
• Has a known history of elevated post-void residual volume defined as greater than 150 mL.
• Has undergone bladder training or electrostimulation within 28 days prior to Screening or plans to initiate either during the study.
• Has an active or recurrent (> 3 episodes per year) urinary tract infection by clinical symptoms or pre-defined laboratory criteria.
• Has a requirement for an indwelling catheter or intermittent catheterization.
• Has received an intradetrusor injection of botulinum toxin within 9 months prior to Screening.
• Has uncontrolled hyperglycemia (defined as fasting blood glucose > 150 mg/dL or 8.33 mmol/L and/or non-fasting blood glucose > 200 mg/dL or 11.1 mmol/L) or, if in the opinion of the Investigator, is uncontrolled.
• Has evidence of diabetes insipidus.
• Is pregnant, breast-feeding, or is planning to conceive within the projected duration of the study.
• Has a concurrent malignancy or history of any malignancy within 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
• Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mmHg and/or diastolic blood pressure of ≥ 100 mmHg) or has a resting heart rate (by pulse) > 100 beats per minute.
• Has narrow angle glaucoma (primary open angle glaucoma is not excluded).
• Has a history of cerebral vascular accident, transient ischemic attack, unstable angina, myocardial infarction, coronary artery interventions (e.g., coronary artery bypass grafting or percutaneous coronary interventions [e.g., angioplasty, stent insertion]), or neurovascular interventions (e.g., carotid artery stenting) within 6 months prior to the Screening Visit. Has a known history of liver disease.
• Has a history of injury, surgery, or neurodegenerative diseases (e.g., multiple sclerosis, Parkinson's) that could affect the lower urinary tract or its nerve supply.
• Has hematuria, including microscopic hematuria according to pre-defined criteria.
• Has clinically significant electrocardiogram (ECG) abnormality.
• Has alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome).
• Has an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2.
• Has an allergy, intolerance, or a history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of the vibegron formulation or tolterodine formulation.
• Is currently participating or has participated in a study with an investigational compound or device within 28 days prior to signing informed consent, or has participated in any previous study with vibegron.