A Study to Evaluate Tolerability and Patient Preference Between Myrbetriq® and Detrol® LA in Subjects With Overactive Bladder (OAB)

The study will comprise of two double-blind treatment periods with a wash-out period in
between.

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
incontinence) for greater than or equal to 3 months prior to Screening.

- Subject must be treatment-naïve to pharmaceutical agents for OAB.

- Female subject must not donate ova starting at Screening and throughout the study
period, and for 30 days after the final study drug administration.

- Male subject must not donate sperm starting at Screening and throughout the study
period and for at least 30 days after final study drug administration.

- Subject agrees not to participate in another interventional study from the time of
screening until the final study visit.

- Inclusion Criteria assessed at Visit 2 (Week 0) based on the 3-day micturition diary:

- Subject continues to meet all inclusion criteria of Visit 1.

- Subject must experience at least 3 episodes of urgency (grade 3 or 4) during the
3 day micturition diary.

- Subject must experience an average of greater than or equal to 8
micturitions/day on the 3 day micturition diary

Exclusion Criteria:

- Female subject who is lactating or is intending to breastfeed during the study period
and for 30 days after the final study visit.

- The subject has clinically significant bladder outlet obstruction (BOO) posing a risk
of urinary retention.

- Subject has significant stress incontinence or mixed stress/urgency incontinence
where stress is the predominant factor.

- Subject has evidence of Urinary Tract Infection (UTI) (urine culture greater than
100,000 cfu/mL) as assessed at Screening (Visit 1). The subject can be rescreened
after successful treatment of the UTI (confirmed by a laboratory result of negative
urine culture).

- Subject has a neurological cause for detrusor overactivity (e.g., neurogenic bladder,
diabetic neuropathy or systemic or central neurological disease such as multiple
sclerosis and Parkinson's disease).

- Subject has an indwelling catheter or practices intermittent self-catheterization.

- Subject has a chronic inflammatory condition such as interstitial cystitis, bladder
stones, previous pelvic radiation therapy, or previous or current malignant disease
of the pelvic organs (i.e., within the confines of the pelvis including the bladder
and rectum in both sexes and the uterus, ovaries, and fallopian tubes in females); or
of the lower gastrointestinal tract.

- Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe
colitis ulcerosa, toxic megacolon, myasthenia gravis, polio or any other medical
condition which makes the use of anticholinergics contraindicated.

- Subject has received intravesical injection in the past 12 months with botulinum
toxin, resiniferatoxin, or capsaicin.

- Subject has received invasive treatment including electro-stimulation therapy.

- Subject is receiving a bladder training program or pelvic floor exercises which
started or has changed less than 30 days prior to Screening.

- Subject has hepatic impairment defined as Child-Pugh Class A, B or C.

- Subject has severe renal impairment defined as creatinine clearance less than 30
mL/min. A subject with End Stage Renal Disease or undergoing dialysis is also not a
candidate for the study.

- Subject has severe uncontrolled hypertension, which is defined as a sitting systolic
blood pressure greater than or equal 180 mmHg and/or diastolic blood pressure greater
than or equal 110 mmHg.

- Subject has evidence of QT prolongation on electrocardiogram (ECG) defined as QTcF
greater than 450 msec for males, QTcF greater than 470 msec for females or a known
history of QT prolongation.

- Subject has a serum creatinine greater than 150 µmol/L, or aspartate aminotransferase
(AST) or alanine aminotransferase (ALT) greater than 2x upper limit of normal (ULN),
or γ-GT greater than 3x ULN and considered clinically significant.

- Subject has a hypersensitivity to any components of Myrbetriq (mirabegron), other
β-AR agonists, tolterodine or other antimuscarinic agents, or any of the inactive
ingredients.

- Subject has been treated with an experimental device within 30 days or received an
investigational agent within 30 days prior to Screening.

- Subject has a concurrent malignancy or history of any malignancy (within the past 5
years), except non-metastatic basal or squamous cell carcinoma of the skin that has
been treated successfully.

- Subject with current history of alcohol and/or drug abuse.

- Subject is involved in the conduct of the study as an employee of the Astellas group,
third party associated with the study, or the study site team.

- Exclusion Criteria assessed at Visit 2 (Week 0):

- Subject fulfills any exclusion criteria at Visit 1.