Please select the eligibility criteria that correspond to the clinical trial below.
Title: An International Phase 3, Randomized, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder
Brief Summary: This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in patients with OAB.


Options:
A: Inclusion Criteria:

* Ambulatory 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 OAB-questionnaire

Exclusion Criteria:

* Patient has stress or mixed incontinence
* Patient has Benign Prostatic Hyperplasia with severe lower urinary tract symptoms based on IPSS score
* Patient has uncontrolled Diabetes Mellitus Type II Patient has Diabetes Insipidus, UTI
* Patient has history of interstitial cystitis, painful bladder syndrome, or chronic pelvic pain
* Patient has a history of stroke, seizures, or major neurological disorders
* Patient has a history of fecal incontinence and or continual urine leakage
* Patient has had surgery to correct stress urinary incontinence or pelvic organ prolapse within 6 months of study start
* Patient received bladder training of electrostimulation within 2 weeks of study start
* Patient requires a catheter
* Patient is taking medications that cannot be stopped for the duration of the trial including certain anticholinergics or smooth muscle relaxants
* Patient began taking tricyclic antidepressants, serotonin/norepinephrine reuptake inhibitors, calcium channel blockers, ephedrine/pseudoephedrine, or diuretic therapy less than 8 weeks before study start
* Patient has been on hormone replacement therapy for less than 12 weeks at study start
* Patient must take medication for arrhythmia, contraindicated for Solifenacin or Gabapentin
* Patient has multiple and/or severe allergies to foods and drugs
* Patient regularly uses any illegal drugs
B: Inclusion Criteria:

1. Outpatients with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria.
2. Age 40 years to 80 years.
3. Stable dose of antiparkinsonian medication 4 weeks prior to study entry.
4. Patients must score 1.0 to 3.0 on the Modified Hoehn and Yahr scale.
5. Women of child-bearing potential must use a reliable method of contraception.
6. Must be experiencing symptoms of overactive bladder according to the ICS definition of a minimum voiding 8 or more times/24 hours and a daily average of at least 1 episode of urgency and/or urinary incontinence (urge incontinence predominately as measured by 3IQ diary) per 24 hours during a 3-day micturition diary period. Patients must have documentation of OAB within the last 6 months.
7. The patient must have evidence of PSA less than or equal to 4 (males only) within the last 12 months (obtained from primary care physician).
8. The patient must have had a bladder scan within six months of the screening visit. This scan uses ultrasound technology to measure residual fluid levels in the bladder after urination. This scan must document post void residual of 200 mls or less. A bladder scan printout or a note documenting these findings must be provided before baseline.
9. Clearance from the patient's internist or primary care health provider who has examined the patient within the last 6 months.

Exclusion Criteria:

1. Any illness that in the investigator's opinion preclude participation in this study.
2. Pregnancy or lactation.
3. Concurrent participation in another clinical study.
4. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam scores less than 27).
5. Legal incapacity or limited legal capacity.
6. History of prostate cancer or Transurethral resection of the prostate (TURP) (males only).
7. Presence of severe renal disease. BUN 50% greater than normal (normal BUN levels should be within a range of 5 to 20 mg/ d L and creatinine between .7 and 1.4 mg/ d L). Labs within the past 12 months will be requested from the patient's health care provider or urologist. If labs are not available within this time-frame or if results are abnormal, labs will be obtained as part of the screening visit.
8. Presence of major hepatic impairment (cirrhosis, viral hepatitis, nonalcoholic steatohepatitis, Wilson's disease, or Hemochromotosis).
9. Currently taking ketaconazole (anti-fungal) or any CYP3A4 inhibitor such as itraconazole, ritonavir, nelfinavir, clarithromycin, or nefazadone.
10. Any history of bladder outflow obstruction or gastrointestinal obstructive disorders.
11. History of narrow angle glaucoma.
12. Patients who have undergone pelvic radiation at any time.
13. Currently taking any of the following medications:

    * Antiarrhythmics: flecainide (Almarytm, Apocard, Ecrinal, Flécaine), digoxin (Lanoxin, Digitek, Lanoxicaps)
    * Antipsychotics: thioridazine (Mellaril, Novorizadine, Thioril)
    * Tricyclic anti-depressants: amitriptyline (Elavil, Tryptanol, Endep, Elatrol, Tryptizol, Trepiline, Laroxyl), amoxapine (Asendin, Asendis, Defanyl, Demolox, Moxadil), clomipramine (Anafranil), desipramine (Norpramin, Pertofrane), imipramine (Antideprin, Deprenil, Deprimin, Deprinol, Depsonil, Dynaprin, Eupramin, Imipramil, Irmin, Janimine, Melipramin, Surplix, Tofranil), nortriptyline (Aventyl, Pamelor, Nortrilen), protriptyline (Vivactil), trimipramine (Stangyl, Surmontil, Rhotrimine)
    * Psychotropics: doxepin (Aponal, Adapine, Sinquan, Sinequan)
    * Anticholinergics/Antispasmodics: trihexyphenidyl (Artane, Aparkan), benztropine (Cogentin), oxybutynin (Ditropan, Ditropan XL, Lyrinel XL, Oxytrol), darifenacin (Enablex), emepronium, flavoxate (Urispas), meladrazine, propiverine, solifenacin (Vesicare), tolterodine (Detrol, Detrol LA), trospium (Sanctura)
    * Selective Serotonin-Norepinephrine Reuptake Inhibitors (SNRI): duloxetine (Cymbalta, Yentreve), Venlafaxine (Effexor, Effexor XR)
    * Arylalkylamines: pseudoephedrine (Sudafed)
    * Anti-androgen: bicalutamide (Casodex, Cosudex, Calutide, Kalumid), finasteride (Proscar, Propecia, Fincar, Finpecia, Finax, Finast, Finara, Finalo, Prosteride, Gefina, Finasterid IVAX), dutasteride (Avodart, Avidart, Avolve, Duagen, Dutas, Dutagen, Duprost), Zoladex (goserelin acetate), Eulexin (flutamide), Lupron (leuprolide acetate)
    * Antihypertensives: prazosin (Minipress, Vasoflex, Hypovase)
    * Estrogens (Menest, Premarin, Premarin IV)
    * Acetylcholinesterase inhibitors (rivastigmine (Exelon), galantamine, (Reminyl, donepezil (Aricept), Tacrine.
    * Memantine (Namenda)
14. Urinary obstruction in male PD patients as diagnosed by a urologist
15. Active urinary tract infection.
16. Patients with a history of chronic severe constipation (by self report)
C: 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.
D: Inclusion Criteria:

* Symptoms of overactive bladder (described as urinary urgency, with or without urge incontinence, usually with frequency and nocturia for more than 6 months
* Bladder wall thickness of 5mm or more

Exclusion Criteria:

* Treatment in the previous four weeks with an anticholinergic drug or any drug for the treatment of overactive bladder.
* Significant stress incontinence - Urinary tract infection or a history of intermittent urinary tract infections (more than four episodes in the last two years).
* Conditions considered significant by the investigator (e.g. cystocoele, significant bladder prolapse, bladder stone, indwelling catheter etc)

Answer: C