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

Inclusion Criteria:

1. Has a history of OAB for at least 3 months prior to the Screening Visit.

2. Meets either the OAB Wet or OAB Dry criteria.

Exclusion Criteria:

Urology Medical History

1. Patient had an average total daily urine volume > 3000 mL in the past 6 months or
during the 14-day Run-in Period.

2. Has lower urinary tract pathology that could, in the opinion of the Investigator, be
responsible for urgency, frequency, or incontinence.

3. Has a history of surgery to correct stress urinary incontinence, pelvic organ
prolapse, or procedural treatments for BPH within 6 months of Screening.

4. Has current history or evidence of Stage 2 or greater pelvic organ prolapse (prolapse
extends beyond the hymenal ring).

5. Patient is currently using a pessary for the treatment of pelvic organ prolapse.

6. Has a known history of elevated post-void residual volume defined as greater than 150
mL.

7. Has undergone bladder training or electrostimulation within 28 days prior to Screening
or plans to initiate either during the study.

8. Has an active or recurrent (> 3 episodes per year) urinary tract infection by clinical
symptoms or pre-defined laboratory criteria.

9. Has a requirement for an indwelling catheter or intermittent catheterization.

10. Has received an intradetrusor injection of botulinum toxin within 9 months prior to
Screening.

11. 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.

12. Has evidence of diabetes insipidus.

13. Is pregnant, breast-feeding, or is planning to conceive within the projected duration
of the study.

14. 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.

15. 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.

16. Has narrow angle glaucoma (primary open angle glaucoma is not excluded).

17. 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.

18. 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.

19. Has hematuria, including microscopic hematuria according to pre-defined criteria.

20. Has clinically significant electrocardiogram (ECG) abnormality.

21. 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).

22. Has an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2.

23. 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.

24. 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.