Please select the eligibility criteria that correspond to the clinical trial below.
Title: Is the a Difference Between Rehabilitation Treatment, Pelvic Floor Muscle Training, Bladder Training and Anticholinergic Drug Treatment in UUI in the Long Term: A Study of Impairment, Quality of Life, and Cost Effectiveness
Brief Summary: * Urinary Urge Incontinence (UUI) is the involuntary urine loss associated with a strong sensation to void.
* UUI usually associated with reduced bladder capacity.
* The pathophysiology is unclear.
* Pelvic floor muscle dysfunction and detrusor instability have been suggested as possible mechanisms.
* Standard treatment includes anticholinergic medication and behavior modification.
* The study aims to compare the long term effectiveness of 4 different approaches to the treatment of women with Urge Urinary Incontinence (UUI):

  1. Pelvic Floor Rehabilitation (includes muscle training+behavioral intervention+bladder training)
  2. Pelvic Floor muscle training alone
  3. Bladder Training alone
  4. Drug treatment with Tolterodine.
* Study variables will include: impairment ratings, quality of life, and cost-effectiveness.
* This study addresses three issues:

  1. The long term efficacy and cost-effectiveness of the various treatment options.
  2. To identify the factors involved in determining the effectiveness of drug or behavioral therapy.
  3. The pathophysiology of UUI. By subdividing the rehabilitation group into 3 arms, we hope to shed light on the mechanism of dysfunction. A better response in one group will help localize the problem to pelvic floor muscles or to detrusor instability.


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:

* Symptoms of overactive bladder (OAB), including urinary frequency, urgency or urge incontinence, for greater than or equal to 3 months
* Urodynamic diagnosis of detrusor overactivity (DO)
* Either naïve to anti-muscarinic treatment (i.e. no prior history of use of anti-muscarinic agents) or 6-months anti-muscarinic treatment free (i.e. have had no anti-muscarinic treatment within 6 months) prior to the screening visit
* Bladder post-void residual volume of less than 30 ml
* Available to complete the study

Exclusion Criteria:

* History of stress urinary incontinence, urethral sphincter incompetence or neurogenic detrusor overactivity
* History, signs or symptoms suggestive of urinary tract infection (confirmed by positive urine analysis), obstruction or urogenital pro-lapse (greater than grade II)
* History of urinary tract operation within 6 months prior to screening
* Indwelling catheter or permanent catheter fitted
* History of pelvic area radiotherapy treatment
* Uncontrolled diabetes mellitus
* History of fibromyalgia
* Post-partum or breast-feeding within 3 months prior to screening visit
* Either pregnant or intends to become pregnant during the study or sexually active, of childbearing potential and is unwilling to utilize a reliable method of birth control (note: reliable methods are contraceptive pills of combination type, hormonal implants or injectable contraceptives)
* Positive pre-study hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus (HIV) result at time of screening
* History of drug and / or alcohol abuse at time of screening
* 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
* Undergoing hemodialysis or has severe renal impairment or moderate hepatic impairment or who are on treatment with a potent cytochrome p450 (CYP) 3A4 inhibitor, e.g. Ketoconazole
* Currently dosing with medication(s) intended to treat overactive bladder symptoms or has a history of non-drug treatment, such as electrical therapy, magnetic field stimulation, pelvic floor treatment or bladder training intended to treat overactive bladder symptoms within 6 months prior to screening, as described in the list of prohibited medications
* Currently receiving or has a history of treatment with alpha blockers, botulinum toxin (cosmetic use is acceptable), resiniferatoxin or pelvic floor muscle relaxants within 9 months prior to screening
* Participated in any clinical study less than or equal to 3 months prior to screening
C: Inclusion Criteria:

* Inclusion Criteria at Visit 1/Screening:

  * Subject has a Body Mass Index (BMI) of between 18 and 35 kg/m\^2 and a total body weight between 50 and 95 kg;
  * Subject is willing and able to complete the micturition diary and questionnaires correctly and is willing 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 has symptoms of overactive bladder (OAB; urinary frequency, urgency and/or urgency incontinence) for at least 3 months.
* Inclusion Criteria at Visit 3/Baseline:

  * Subject has experienced frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period (incontinence episode should not be counted as a micturition);
  * Subject must experience at least 1 episode of urgency (grade 3 or 4) per 24-hour period (with or without urgency incontinence) during the 3 day micturition diary period.

Exclusion Criteria:

* Exclusion Criteria at Visit 1/Screening:

  * Subject is breastfeeding, pregnant or intends to become pregnant during the study. The pregnancy test (Beta Human Chorionic Gonadotropin in serum) at Screening must be negative in women of childbearing potential;
  * Female subjects of childbearing potential and not using a highly effective method of birth control during the study and for 30 days after final study drug administration.
  * Male subjects (unless surgically sterile) with female spouses/partners who are of childbearing potential, and not using a barrier method of contraception during the study and for 30 days after final study drug administration. In addition, female spouses/partners of male subjects and who are of childbearing potential should also use a highly effective method of birth control during the study and for 30 days after final study drug administration. Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly.
  * Subject has significant post-void residual (PVR) volume (\> 150 mL);
  * Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the Investigator (for female subjects confirmed by the cough provocation test);
  * Subject has a neurological cause for detrusor overactivity;
  * Subject has an indwelling catheter or practices intermittent self-catheterization;
  * Subject has diabetic neuropathy;
  * Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs;
  * Subject has had previous lower urinary tract or pelvic floor surgery (except cystoscopy);
  * Subject has had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin;
  * Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis or Crohn's Disease, toxic megacolon, myasthenia gravis or any other condition which makes the use of anticholinergics contraindicated;
  * Subject has clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Screening, such as myocardial infarction, uncontrolled angina, significant ventricular arrhythmias, heart failure and stroke;
  * Subject is receiving current non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to Screening);
  * Subject is using medications intended to treat OAB or prohibited medications.
  * Subject has known or suspected hypersensitivity to solifenacin succinate, mirabegron or any of their excipients;
  * Subject has any significant neurological disease or defect affecting bladder function (e.g., neurogenic bladder, systemic or central neurological disease such as multiple sclerosis \[MS\] and Parkinson's disease);
  * Subject has severe hypertension which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or an average diastolic blood pressure ≥ 110 mmHg;
* Exclusion Criteria at Visit 2/Placebo Run-In:

  * Subject has evidence of a urinary tract infection (UTI) (urine culture containing \> 100,000 cfu/mL). The subject can be enrolled into the study after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture). However, the subject must be re screened if the initial screening visit was \> 28 days;
  * Subject has a QT interval \> 450 ms or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia) or is on drug treatment known to be associated with QT prolongation;
  * Subject has clinically significant abnormalities on the 12 lead electrocardiogram (ECG);
  * Subject has serum creatinine \> 150 µmol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2x upper limit of normal (ULN), gamma-glutamyltransferase (γ-GT) \> 3x ULN, or total bilirubin \> 2x ULN, as assessed in Screening samples;
* Exclusion Criteria at Visit 3/Baseline:

  * Subject had an average total daily urine volume \> 3000 mL as recorded in the micturition diary period;
  * Subject has severe hypertension which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or an average diastolic blood pressure ≥ 110 mmHg.
D: Inclusion Criteria:

* At least 1 urinary urgency episode/24h (on average) documented in a 3-day patient diary in the screening phase with or without urge incontinence, and usually with frequency and nocturia, described as OAB
* Patients may be included if they were never exposed to anticholinergic agents specified for the treatment of OAB. Patients may also be included if they have previously been treated with FDA-approved anticholinergic agents for the treatment of OAB such as oxybutynin chloride and are no longer receiving such treatment for a minimum of 14 days immediately preceding entry into the study. These previously treated patients must present at the investigative site on no anticholinergic agents and with the desire to receive treatment for OAB. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.
* Patients having urgency with or without urge incontinence accompanied by frequency of ≥8 episodes per 24 hours, and/or nocturia, for a period of ≥3 months prior to screening.

Exclusion Criteria:

* Previous treatment with darifenacin
* Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for \<3 months
* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the Investigator
* Evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
* Clinically significant outflow obstruction (benign prostatic hyperplasia) as determined by the Investigator

Answer: A