Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder
Brief Summary: The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.


Options:
A: Inclusion Criteria:

* Adult overactive bladder (OAB) patients who present with OAB symptoms, including urinary frequency \>= 8 per day and urgency urinary incontinence \>=1 per day

Exclusion Criteria:

* Patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention.
* Patients with significant hepatic and renal disease or other significant unstable diseases.
* OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
B: 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.
C: Inclusion Criteria:

* Subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
* Subject had symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months;

Exclusion Criteria:

* Subject had significant PVR volume (\> 150 mL);
* Subject had a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and Parkinson's disease with autonomic component or bladder involvement). An autonomic component could be inferred when autonomic functions were affected, including heart rate, blood pressure, perspiration and digestion.
* Subject had an indwelling catheter or practices intermittent self catheterization.
* Subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis.
* Subject had received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
* Subject had moderate to severe hepatic impairment
* Subject had severe renal impairment
* Subject had a clinically significant abnormal ECG
* Subject had a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
* Subject had an average QTcF interval \> 450 ms for males or \> 470 ms for females based on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
* Subject had severe hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.
D: Inclusion Criteria:

* Patient is willing and able to complete the micturition diary correctly.
* Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for \>= 3 months
* At least 3 episodes of urgency with or without incontinence in last 3 days
* At least three episodes of urgency with or without incontinence (PPIUS grade 3 or 4) during the 3-day micturition diary period
* Patient must experience frequency of micturition on average \>= 8 times per 24-hour period during the 3-day micturition diary period

Exclusion Criteria:

* Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practising an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants and injectable or patch contraceptives
* Clinically significant outflow obstruction (at the discretion of the investigator)
* Significant post void residual volume (PVR\>200ml)
* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
* Patient with indwelling catheters or practising intermittent self-catheterisation
* 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
* Hypersensitivity to solifenacin or to any of the excipients, uncontrolled narrow angle glaucoma, myasthenia gravis, urinary or gastric retention, severe renal impairment (GFR ≥30 ml/min), moderate or severe hepatic impairment, chronic intestinal disease, megacolon, requirement for dialysis, concomitant use of a strong CYP3A4 inhibitor, e.g. ketoconazole
* Non drug OAB treatment such as bladder-training, biofeedback and pelvic floor exercises are permissible if established at least 4 weeks prior to study start and intended to be continued throughout the study; electrostimulation therapy is not permissible at any time
* Use of drugs intended to treat urinary incontinence
* Diabetic neuropathy
* Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial
* Participation in any clinical trial within 30 days prior to randomisation
* Employees of the Yamanouchi Group, third parties associated with the study, or the study site
* Patient who did not complete the micturition diary according to the instructions

Answer: C