Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects With Symptoms of Overactive Bladder
Brief Summary: The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.


Options:
A: Inclusion Criteria:

* Subject has signed informed consent.
* Females at least 21 years of age
* Five or more urge urinary incontinence episodes on a three-day voiding diary. Urge incontinence episodes will be determined based on voiding diary and subject indication of coincident urge symptoms, allowing self-characterization of incontinence type.
* Urge predominant (urge \>50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary.
* Demonstrated ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization in the event that this would be required.
* Request for treatment for urge urinary incontinence. The patient may have tried other non-pharmacologic treatments for urge incontinence, such as supervised behavioral therapy, supervised physical therapy, unsupervised physical therapy, supervised biofeedback, and transvaginal electrical stimulation.
* Subject has undergone 3-week washout period if subject were on anticholinergic therapy prior to enrollment.
* Subject is able to complete all study related items and interviews.

Exclusion Criteria:

* Any previous therapy with trospium chloride, solifenacin, or darifenacin
* Failed three or more anticholinergic drugs.
* Contraindication to anticholinergic therapy, specifically with solifenacin or trospium.
* Current symptomatic urinary tract infection that has not resolved prior to randomization.
* Uncontrolled narrow-angle glaucoma
* Gastric retention
* Baseline need for intermittent self catheterization
* PVR \>150ml on 2 occasions with void(s) of greater than 150ml
* Surgical treatment for stress incontinence (sling, Burch or urethral injection) or pelvic organ prolapse recommended or planned at enrollment by study investigator(s).
* Any prior intra-detrusor botulinum toxin A injections
* Previous or currently implanted neuromodulation (sacral or tibial).
* Surgically altered detrusor muscle, such as augmentation cystoplasty.
* Known allergy to botulinum toxin A.
* Women with known neurologic disease believed to potentially affect urinary function (Multiple sclerosis, spinal cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease).
* Known allergy to lidocaine.
* Currently pregnant or lactating patients or patients planning pregnancy within the next year.
* Sexually active premenopausal women with a uterus who have either not had a tubal ligation or are not on a medically approved form of contraception for at least 3 months prior to and throughout the duration of the study.
* Cystoscopic findings that preclude injection, in the opinion of the investigator.
* Current or prior bladder malignancy.
* In the opinion of the investigator, inability to understand diary instructions and complete 3-day voiding diary.
* Subjects who are on anticoagulant therapy,excluding aspirin
* Subject has been previously diagnosed with interstitial cystitis or chronic pelvic pain syndrome.
* Subjects with hematuria who have not undergone a clinically appropriate evaluation.
* Subjects taking aminoglycosides at the time of injection.
* Serum creatinine level greater than twice the upper limit of normal within the previous year.
* Two or more hospitalizations for medical conditions in the previous year.
* Plans to move out of area in the next 6 months.
B: Inclusion Criteria:

* Subject is willing and able to complete the micturition diary and questionnaires correctly
* Subject has symptoms of overactive bladder (urinary frequency and urgency with or without urge incontinence) for ≥ 3 months
* Subject experiences frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
* Subject must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence, during the 3-day micturition diary period

Exclusion Criteria:

* Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
* Subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
* Subject has an indwelling catheter or practices intermittent self-catheterization
* Subject has diabetic neuropathy
* Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
* Subject receives non-drug treatment including electro-stimulation therapy
* Subject has severe hypertension
* Subject has a known or suspected hypersensitivity to tolterodine, other anticholinergics, YM178, other beta-adrenoreceptor (ß-AR) agonists, or lactose or any of the other inactive ingredients
* Subject has been treated with any investigational drug or device within 30 days (90 days in the UK)
* Subject had an average total daily urine volume \> 3000 mL as recorded in the 3-day micturition diary period
* Subject has serum creatinine \>150 umol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2x upper limit of normal range (ULN), or gamma glutamyl transferase (γ-GT) \> 3x ULN
* Subject has a clinically significant abnormal electrocardiogram (ECG)
C: Inclusion Criteria:

* Mean urinary frequency of \>=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2)
* Mean number of micturition related urgency episodes \>=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating \>=3)
* Mean number of micturition related nocturnal urgency episodes \>=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of \>3 recorded in the bed time section of the bladder diary)

Exclusion Criteria:

* A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia
* Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.
D: Inclusion Criteria:

* Female 50 or older
* Diagnosis of OAB (ICS definition)
* English literacy
* Ability to swallow oral medication
* Cognitive ability to give consent

Exclusion Criteria:

* Dementia/Depression/Delirium
* Current anticholinergic use (requires 2 week washout period)
* Current cholinesterase
* Urinary or gastric retention
* Severe decreased gastrointestinal motility
* Uncontrolled narrow-angle glaucoma
* Myasthenia gravis
* Diagnosis fo renal impairment (creatinine clearance \<30 mL/min)

Answer: B