Please select the eligibility criteria that correspond to the clinical trial below.
Title: Solifenacin in the Treatment of Urgency Symptoms of Overactive Bladder in a Rising Dose, Randomized, Placebo-controlled, Double-blind Trial
Brief Summary: Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose increase. Primary efficacy assessment of OAB symptoms by patient diaries.


Options:
A: Inclusion Criteria:

* Male
* Community-dwelling
* Veteran
* Self-reported urgency
* Self-reported frequent urination
* Mean of \> 8 voids per 24-hour day on bladder diary
* Able to come to clinic

Exclusion Criteria:

* Urologic surgery in the past 6 months
* Nonambulatory (unless has independent transfer skills)
* Flow rate \< 5mL at baseline and \< 10mL/sec after run-in (on simple uroflowmetry)
* Post-void residual urine volume \> 250mL at baseline and \> 150mL after run-in (on bladder ultrasound)
* Continual leakage
* Urinary tract infection (growth of \> 100,000 colonies per ml of a urinary pathogen on urine culture). May be reconsidered after treatment and negative culture.
* Fecal impaction
* Poorly controlled diabetes (glycosylated hemoglobin \>9 within last 3 months)
* Hematuria on microscopic examination in the absence of infection
* Any unstable medical condition (particularly: decompensated congestive heart failure, malignant arrhythmias, unstable angina)

  -- Impaired mental status (\< 24 on Folstein's Mini-Mental State Exam)
* Narrow angle glaucoma
* Gastric retention (by medical history)
* Hypersensitivity to tamsulosin or oxybutynin
* Current use of anticholinergic agents for detrusor instability. May be reconsidered after 2-week wash-out.
* If on diuretic, dose has not been stable for at least three months
* Sleep apnea, unless surgically corrected
B: Inclusion Criteria:

* Written informed consent has been obtained
* Subjects with neurogenic detrusor overactivity due to:

  * Multiple sclerosis(MS)(EDSS≤8) or
  * Spinal cord injury(SCI)(partial or complete lesions)
* MS or SCI symptoms should be stable for \>= 6 months
* Neurogenic detrusor overactivity symptoms should be stable for \>= 6 months
* Subject is willing and able to perform clean, intermittent, catheterization, if required
* Subject is willing and able to take study medication in compliance with the protocol

Exclusion Criteria:

* Subjects with neurogenic detrusor overactivity due to Parkinson's or cerebrovascular disease
* Subjects with Sjögren's Syndrome or any similar symptoms
* Subjects with 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
* Subjects with stress incontinence or mixed incontinence where stress is the predominant factor as determined by the investigator
* Subjects with evidence of pressure sores \>= grade 2
* Subjects with a history of bladder sphincterotomy
* Subjects with known history of vesico-ureteral reflux without upper urinary tract infection
* Any clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study or includes a history of acute urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony), severe gastrointestinal conditions (including toxic megacolon or ulcerative colitis), myasthenia gravis, narrow angle glaucoma or shallow anterior chamber
* Subjects undergoing hemodialysis
* Subjects with severe hepatic impairment
* Concurrent use of drugs intended to treat symptoms of overactive bladder
* Use of antidepressants or muscle relaxants which have not been administered at a constant dose for \>= 3 months
* Use of non-drug treatment intended to treat overactive bladder symptoms including electrostimulation therapy, botulinum toxin and vanilloids therapy in the six months prior to the commencement of the study
* Use of permanent, indwelling catheters
* Known or suspected hypersensitivity to solifenacin succinate, oxybutynin hydrochloride, other anti cholinergics or lactose
* Concomitant use of a strong CYP3A4 inhibitor, e.g. ketoconazole
* Pregnant women, women who intend to become pregnant during the study, women of childbearing potential who are sexually active and practicing an unreliable method of birth control or women who will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants and injectable contraceptives
* Participation in any clinical study within 30 days of randomization, or the limit set by national law, whichever is longer
* Employees of the Astellas Group, third parties associated with the study, or the study site
* Subjects with maximum bladder capacity \>= 400ml at visit 2
C: 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
D: 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

Answer: C