Please select the eligibility criteria that correspond to the clinical trial below.
Title: A PHASE 2, 16 WEEK, MULTICENTER, RANDOMIZED, DOUBLE BLIND PLACEBO CONTROLLED, PARALLEL GROUP PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PF-04383119 FOR THE TREATMENT OF PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS
Brief Summary: The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis.


Options:
A: Inclusion Criteria:

* Male and female adults at least 18 years of age;
* Moderate to severe interstitial cystitis, with a mean pain intensity score above a pre-defined level.

Exclusion Criteria:

* Less than 6 months since onset of interstitial cystitis symptoms;
* History of recurrent urinary tract infections, or genitourinary cancer;
* History of hepatitis B, C or human immunodeficiency virus (HIV);
* Use of certain drugs given into the bladder up to 1 month prior to study entry.
B: Inclusion Criteria:

* longer than 6 months of bladder pain syndrome/interstitial cystitis with Hunner Lesion(s) during cystoscopy

Exclusion Criteria:

* Pregnancy
* neurologic diseases
* urinary tract infections
* bladder outlet obstruction
* previous pelvic radiotherapy
C: Inclusion Criteria:

* Female
* Age 18 to 85 years
* History of patient self-reported of IC/BPS symptoms for at least 6 months.
* Using an approved method of birth control, or surgically sterile, or of non-child bearing age with no menstrual period for the past 12 months
* Must be willing to not start any new medication known to affect bladder or muscle function, and to ideally remain on a stable dose of all other medications through the secondary endpoint.

Exclusion Criteria:

* Active urethral or ureteral calculi, urethral diverticulum, history of pelvic radiation therapy, tuberculous cystitis, bladder cancer, carcinoma in situ (bladder), urethral cancer
* Hunner's lesions found on screening cystoscopy
* Prior investigational or therapeutic bladder instillations for IC/BPS symptoms within the past 3 months
* Lactation, pregnancy, or refusal of medically approved/reliable birth control in women of child-bearing potential.
* Pain, frequency, and/or urgency symptoms only present during menses
* Clinically confirmed urinary tract infection at time of screening
* Participant unable to tolerate insertion of one or two vaginal examining fingers (e.g. Vulvar allodynia)
* Participant had prior course of physical therapy (PT) that included internal (vaginal and/or rectal) manual therapy with connective tissue manipulation by physical therapist for the same symptoms within the past 3 months (prior treatment by therapist with biofeedback, electrical stimulation, or pelvic floor exercises is not exclusionary)
* Participant in the opinion of the investigator has a relevant neurologic disorder that affects bladder and/or neuromuscular function
* Participant has/reports any severe, debilitating or urgent concurrent, medical condition
* Participant has a potentially significant pelvic pathology or abnormality on examination or prior imaging, including prolapse beyond the hymenal ring, pelvic mass, etc., that in the investigators' judgment, could cause or contribute to the clinical symptoms, or require treatment
* Any other condition which, in the investigator's judgment, may increase risk to subject's welfare
* Participation in an investigational trial that uses a study treatment less than 6 months from the date of the screening visit

Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.
D: Inclusion Criteria:

1. Adults with age of 20 years old or above
2. Patients with symptoms of unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six months duration, in the absence of infection or other identifiable causes
3. Patients has received cystoscopy and ruled out other bladder lesion
4. Free of active urinary tract infection
5. Free of bladder outlet obstruction on enrollment
6. Free of overt neurogenic bladder dysfunction and limitation of ambulation
7. Patient or his/her legally acceptable representative has signed the written informed consent form

Exclusion Criteria:

1. Patients had received intravesical hyaluronic acid treatment in recent 3 months, or intravesical Botox injection in recent 12 months Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
2. Patients with bladder outlet obstruction on enrollment
3. Patients with PVR \>100 ml
4. Patients with uncontrolled confirmed diagnosis of acute urinary tract infection
5. Patients have laboratory abnormalities at screening including: alanine aminotransferase (ALT)\> 3 x upper limit of normal range, and aspartate aminotransferase (AST) \> 3 x upper limit of normal range
6. Patients have abnormal serum creatinine level \> 2 x upper limit of normal range
7. Female patients who is pregnant, lactating, or with child-bearing potential without contraception
8. Patients with any other serious disease considered by the investigator not in the condition to enter the trial
9. Patients had received intravesical treatment for IC within recent 1 month
10. Patients had participated investigational drug trial within 1 month before entering this study
11. Patients with coagulopathy

Answer: A