Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Placebo-controlled Clinical Trial Comparing Fesoterodine to Placebo in Women Diagnosed With Urge Urinary Incontinence by the 3 Incontinence Questions (3IQ). Followed by a Multi-center Open Label Clinical Cohort Study of Long-term Effects of Treatment With Fesoterodine.
Brief Summary: Six hundred and thirty-six women diagnosed with urge urinary incontinence (UUI) by a three-item self-administered questionnaire (3IQ) will be randomized to 12 weeks of fesoterodine or matching placebo. The study will take place at up to 14 clinical sites in the US. All participants who complete the 12-week randomized trial will be offered open-label fesoterodine for an additional 9 months.

The hypothesis of the randomized controlled trial is that among women diagnosed with urge incontinence using the 3IQ, fesoterodine is more effective than placebo in reducing the mean number of urge incontinence episodes per day.


Options:
A: 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
B: Inclusion Criteria:

* Ambulatory females ≥ 18 years old
* Urge Urinary Incontinence (subject-reported) for ≥ 3 months prior to Screening (Visit 1)
* On the 3IQ: Response b to Question 3: During the last 3 months, did you leak urine most often: b. When you had the urge or the feeling that you needed to empty your bladder, but could not get to the toilet fast enough?
* On a 3-day bladder diary, documentation of an average of 1 UUI episode per 24 hours (3 UUI episodes in 3 days)
* Capability of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risk and benefits
* Ability to perform all procedures and tests required by the protocol
* Willingness to remain on stable medication regime for duration of the randomized controlled trial. Participants will be asked to not add new medications during the randomized controlled trial, such as diuretics and other medications which may affect their voiding pattern.

Exclusion Criteria:

* Any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active drug (fesoterodine fumarate) and its ingredients or any of the excipients, history of urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, toxic megacolon, fistula or a hole in your bladder or rectum, birth defect leading to urine leakage, and urine leakage starting in childhood.
* Clinically significant hepatic or renal disease.
* Neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease.
* Symptomatic pelvic organ prolapse defined as participant report of feeling or seeing a bulge outside the vagina within the past 3 months.
* History of lower urinary tract/pelvic surgery (e.g. surgery for incontinence in the past 5 years, surgery in the past 6 months for prolapse or hysterectomy), intra-vesical therapy (botox), and/or bulk injections within the past 6 months.
* A known history of interstitial cystitis or a significant pain component associated with OAB symptoms, uninvestigated hematuria, urogenital cancer, interstitial or external radiation to the pelvis or external genitalia.
* Urinary tract infection (UTI) as shown by the results of the urinalysis at screening or recurrent urinary tract infection (RUTIs) defined as treatment for UTI \>3 times in the last year.
* Use of any electrostimulation, bladder training, or pelvic floor exercises (with certified incontinence practitioners) within 4 weeks of Screening.
* Received study medication in any previous fesoterodine clinical trial.
* Prior failure for either efficacy or tolerability of ≥ 2 OAB medications in the last year. (failure: inadequate symptom control after two medications for a minimum of one month each)
* Has been treated within 2 weeks prior to Screening and/or is currently being treated with: - Any drug treatment for overactive bladder, including antimuscarinic OAB medications.
* Any drugs with significant anticholinergic and antispasmodic effects (see exception for tricyclic antidepressants below)
* Has started treatment with tricyclic antidepressants or estrogens within 4 weeks prior to Screening and/or is not on a stable dose.
* Intermittent or unstable use of diuretics. Treatment with diuretics initiated within 2 weeks prior to baseline is not permitted.
* Treatment with potent CYP3A4 inhibitors, such as clarithromycin, ketoconazole, and itraconazole within 2 weeks prior to Screening.
* Administration of medications capable of inducing hepatic enzyme metabolism or transport (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John's Wort) in the past 30 days.
* Previously received any investigational drug within 30 days prior to trial entry.
* Alcohol and/or any other drug abuse in the opinion of the investigator.
* Participants who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant within 3 months after the completion of the trial.
* Participants that have been pregnant (\> 20 weeks gestation) in the previous 6 months.
* Participants of childbearing potential who are heterosexually active but unwilling or unable to use an adequate form of contraception to prevent pregnancy during the study. Reliable contraceptive methods may include intrauterine devices (IUD), contraceptive pills of combination type, hormonal implants, injectable contraceptives or latex condoms with a spermicide.
* Participants who have any medical (including known history of major hematological, renal, cardiovascular, or hepatic abnormalities) or psychological condition or social circumstances that would impair their ability to participate reliably in the trial, or those who may increase the risk to themselves or others by participating.
* Participants who, in the opinion of the investigator, are not likely to complete the trial for whatever reason.
C: Inclusion Criteria:

* Patients over 18 years suffering from overactive bladder (OAB) for more than 3 months

Exclusion Criteria:

* Pregnant and breastfeeding women
* Any medical condition or need for co-medication which interferes with the drug under investigation (YM178) or the comparator (tolterodine)
D: Inclusion Criteria:

* The subject has mild cognitive impairment as determined by mini-mental state examination (MMSE) ≥ grade 24
* The subject conforms to the Stockholm criteria for mild cognitive impairment as assessed by the investigator
* The subject has a body mass index (BMI) between 18.0 to 30.0 kg/m2 inclusive
* The subject is available to complete the study

Exclusion Criteria:

* The subject has moderate or severe cognitive impairment as determined by MMSE criteria at screening, ≤ grade 23
* The subject has depression as determined by Geriatric Depression Scale (GDS) short form ≥ 5 at screening
* The subject has a history of urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow angle glaucoma or shallow anterior chamber or deemed to be at risk for these conditions
* The subject is undergoing hemodialysis or has severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor, e.g. Ketoconazole
* The subject has uncontrolled diabetes mellitus
* The subject has a positive pre-study hepatitis B surface antigen, hepatitis C antibody or HIV result at time of screening
* The subject has a history of drug and / or alcohol abuse at time of screening
* The subject has an average weekly alcohol intake of greater than 21 units (male) or 14 units (female) within ≤ 3 months prior to screening (1 unit is 270cc of beer, 40cc of spirits or 125cc of wine)
* The subject has a history of smoking more than 10 cigarettes (or the equivalent amount of tobacco) per day within ≤ 3 months prior to screening
* The subject has a history of known or suspected hypersensitivity to solifenacin succinate, oxybutynin hydrochloride, other anti-cholinergics or lactose, to any component of the dosage form
* The subject has taken any unstable doses of prescribed medication within ≤ 1 month prior to screening or over-the-counter medicine (including vitamins and herbal remedies) within 48 hours prior to the first study day, which in the opinion of the Investigator, will interfere with the study procedures or compromise safety
* The subject is currently dosing with medication(s) intended to treat overactive bladder symptoms or has history of non-drug treatment intended to treat overactive bladder symptoms within ≤ 3 months prior to screening
* The subject has any clinically significant abnormality following Investigator review of the physical examination
* The subject has any clinically significant abnormality following the Investigator's review of the ECG
* The subject has mobility impairment that precludes the assessment of postural stability
* The subject has any clinically significant abnormal heart rate or blood pressure measurements, at the screening visit (dBP \> 90mmHg, sBP \> 160mmHg or HR \< 40bpm or \> 100bpm)
* The subject has any clinically significant abnormality following Investigator's review of the biochemistry \& hematology results which, in the opinion of the Investigator, contraindicates their participation
* The subject has donated blood or plasma within ≤ 3 months prior to screening or more than 500ml or 1 unit of blood or plasma within ≤ 6 months prior to screening
* The subject, may find it difficult to adhere to the provisions of treatment and observation specified in the protocol
* The subject has participated in any clinical study within ≤ 3 months prior to screening
* The subject has any clinical condition, diagnosis, symptomatology or ongoing investigation, which, contraindicates their participation
* The subject is an employee of Astellas Pharma, Cognitive Drug Research, and any other third party related to the study site

Answer: B