Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase III Study of YM178 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients With Overactive Bladder
Brief Summary: The purpose of the study is to evaluate the effect of YM178 in patients with overactive bladder for 12-week administration.


Options:
A: Inclusion Criteria:

* Patient with symptoms of overactive bladder for at least 24 weeks before initiation of the pre-investigational period
* Patient capable of walking to the lavatory without assistance and measuring the urine volume by him/herself
* Patient with an average frequency of micturition of 8 or more times per 24-hour period
* Written informed consent has been obtained

Exclusion Criteria:

* Patients without experience of urge incontinence before informed consent
* Patients given a clear diagnosis of stress incontinence
* Patients with transient symptoms suspected of overactive bladder (drug induced, psychogenic, etc)
* Patients complicated with urinary tract infection, urinary stones, and/or interstitial cystitis
* Patients with a previous history of recurrent urinary tract infection
* Patients complicated with or with a history of bladder tumor or prostatic tumor
* Patients confirmed to have a post-void residual volume of ≥ 100 mL or with a clinically significant lower urinary tract obstructive disease
* Patients given medication for the treatment of lower urinary tract obstructive disease within 4 weeks before the pre-investigational period
* Patients with an indwelling catheter or practicing intermittent self-catheterization
* Patients given radiotherapy influencing urethral functions, or thermotherapy for benign prostatic hyperplasia
* Patients given surgical therapy which may influence urethral functions within 24 weeks before the pre-investigational period
* Patients with uncontrolled hypertension or with a pulse rate ≥ 110 bpm or \< 50 bpm
* Patients with polyuria exceeding 3000 mL in mean daily urine volume
* Patients meeting any of the following in the examinations

  * Patients with abnormal electrocardiogram judged inappropriate as subjects by the ECG Evaluation Committee
  * Patients with AST (GOT) or ALT (GPT) 2.5 times higher than the upper limit of the normal range (or 100 IU/L)
  * Patients with a blood creatinine level ≥ 2.0 mg/dL
B: 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.
C: Inclusion Criteria:

1. Patients who are 20 years old or over with overactive bladder
2. Total number of urinary incontinence episodes per week is 5 or over
3. Mean number of micturition per day is 8 or over
4. Mean number of urinary urgency episodes per day is 1 or over
5. Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

1. Patients with genuine stress incontinence
2. Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection
3. Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study
4. Patients suffering from complications for which anticholinergics are contraindicated
5. Other exlcusion criteria as specified in the study protocol
D: Inclusion Criteria:

* Ambulatory male or female subject ≥ 18 years of age and able to use the toilet without difficulty
* History of OAB symptoms for ≥ 3 months
* An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary
* Subjects are bothered by symptoms as reflected by PPBC ≥3

Exclusion Criteria:

* Evidence of chronic urologic inflammation such as interstitial cystitis and bladder stones; uncontrolled narrow angle glaucoma; urinary or gastric retention
* Recurrent urinary tract infection (UTI) of \> 3 episodes within the last 3 months or evidence of a urinary tract infection at Baseline Visit (Visit 2)
* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
* History of renal or hepatic impairment(2 x Upper Limit of Normal(ULN) values in parameters and considered clinically significant by the investigator
* History of diagnosed gastrointestinal obstruction disease
* Subject has a known diagnosis or history of carcinoma (including prostate cancer) except non metastatic basal or squamous cell carcinoma of the skin that has been successfully treated or previous pelvis radiation within the past five years
* Known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics

Answer: A