Please select the eligibility criteria that correspond to the clinical trial below.
Title: URGE-PD: A Multi-site, Double-blind, Randomized, Placebo Controlled Trial of Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease
Brief Summary: This study will assess the effectiveness of solifenacin succinate (VESIcare) in reducing symptoms of overactive bladder in Parkinson's disease (PD) patients.


Options:
A: 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)
B: Inclusion Criteria:

* Ambulatory male or female subject ≥ 18 years of age 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 PPBC ≥3

Exclusion Criteria:

* Evidence of chronic urologic inflammation such as interstitial cystitis and bladder stones; uncontrolled narrow angle glaucoma; urinary or gastric retention
* Recurrent urinary tract infection (UTI) of \> 3 episodes within the last 3 months or evidence of a urinary tract infection at Baseline Visit (Visit 2)
* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
* History of renal or hepatic impairment(2 x Upper Limit of Normal(ULN) values in parameters and considered clinically significant by the investigator
* History of diagnosed gastrointestinal obstruction disease
* Subject has a known diagnosis or history of carcinoma (including prostate cancer) except non metastatic basal or squamous cell carcinoma of the skin that has been successfully treated or previous pelvis radiation within the past five years
* Known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics
C: Inclusion Criteria:

* Overactive bladder syndrome

Exclusion Criteria:

* Less than 8 micturitions in 24 hours
D: Inclusion Criteria:

* complaints of urinary leakage \> 3 in last month (not stress incontinence)
* functionally independent subjects

Exclusion Criteria:

* urinary tract infection
* urogenital prolapse
* unstable diabetes
* neurological or psychiatric disease
* narrow angle glaucoma
* after colposuspension or sling surgery
* Mini Mental State Examination \<24

Answer: A