Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multi-Center, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Daily Dosing With Oxybutynin Topical Gel to Treat the Symptoms of Overactive Bladder With a 14-Week Open-Label Safety Extension
Brief Summary: A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.


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:

* Females and males, 18 years of older with overactive bladder symptoms

Exclusion Criteria:

* Treatable conditions that may cause urinary incontinence
* Medical conditions in which it would be unsafe to use an anti-cholinergic agent.
* The use of concomitant drugs that would confound the efficacy evaluation.
* The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.
C: Inclusion Criteria:

* Female outpatients 18 years or older.
* Overactive bladder symptoms (subject-reported) for greater than or equal to 3 months.
* Currently sexually active with a male partner.

Exclusion Criteria:

* Diagnosed or suspected interstitial cystitis, uninvestigated hematuria, urogenital cancer, and interstitial or external radiation to the pelvis or external genitalia or clinically significant bladder outlet obstruction.
* Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator.
* Treated with antimuscarinic/ anticholinergic medication, for any reason including OAB, within the last 3 months or are expected to start therapy during the study treatment period.
* Any drug for urgency urinary incontinence (UUI) initiated within the past 3 months prior to Visit 1, with the exception of estrogen (topical or systemic) as long as treatment is not initiated within 4 weeks prior to Visit 1 (screening)
D: Inclusion Criteria:

* Symptoms of Overactive Bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months
* Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion Criteria:

* Overactive Bladder caused by neurological condition
* Patient has predominance of stress incontinence
* Use of anticholinergics or other medications to treat OAB symptoms in the 7 days prior to screening
* Previous use of solifenacin
* History or evidence of pelvic or urological abnormality
* Previous use of any botulinum toxin of any serotype for any urological condition
* Previous use of any botulinum toxin of any serotype for any non-urological condition within 12 weeks of randomization
* Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis

Answer: B