Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy, Safety, and Tolerability of JNJ-42160443 in Subjects With Interstitial Cystitis/ Painful Bladder Syndrome
Brief Summary: The purpose of this study is to evaluate the analgesic efficacy, safety, and tolerability of JNJ-42160443 compared to placebo in patients with moderate to severe, chronic bladder pain from interstitial cystitis and/or painful bladder syndrome.


Options:
A: Inclusion Criteria:

* Be females, ≥18 and ≤75 years of age, who have consistently had symptoms of bladder pain in addition to urinary urgency and/or urinary frequency for more than 12 months
* Have had the diagnosis of interstitial cystitis for \> 6 months (pain for at least 12 months) but ≤15 years
* Have average daily pain score of at least 5 out of 10 on the 11-point Numerical Rating Scale \[NRS\] pain scale in the 9 days prior to baseline
* Have undergone a cystoscopy and have documented visible signs of bladder bleeding, lesions or glomerulation within the last 36 months prior to baseline.
* Subjects if of child bearing potential, must agree to avoid pregnancy and use medically acceptable method of contraception from screening visit and throughout the study.
* Must be capable of voiding independently

Exclusion Criteria:

* Pelvic floor pain (\>5 out of 10 on the 11-point NRS pain scale following a pelvic pain assessment)
* Have a body mass index \[BMI\] of \<18 kg/m2 or \>39 kg/m2
* Have had a urinary tract infection including bacterial cystitis within the past 30 days.
* Have greater than 1+ hematuria on dipstick test at screening from an unknown cause
* History of previous procedure(s) (augmentation cystoplasty, cystectomy, or cystolysis) that has affected bladder function
B: Inclusion Criteria:

* Patients with IC/PBS who have failed conventional treatments for at least 6 months will be enrolled.
* A diagnosis of IC/PBS has been established based on characteristic symptoms and cystoscopic findings of glomerulations, petechia, or mucosal fissures after hydrodistention.
* All patients have been treated with at least two types of treatment modalities including non-steroid anti-inflammatory drugs, oral pentosan polysulfate sodium (PPS), intravesical instillation of heparin, hyaluronic acid, or tricyclic antidepressant for at least 6 months but the symptoms remained unchanged or relapsed.

Exclusion Criteria:

* Exclusion criteria proposed by NIDDK
* Automatic exclusions:

  1. Age \<18 years old
  2. Benign or malignant bladder tumors
  3. Radiation cystitis Tuberculous cystitis
  4. Bacterial cystitis
  5. Vaginitis
  6. Cyclophosphamide cystitis
  7. Symptomatic urethral diverticulum
  8. Uterine, cervical, vaginal, or urethral cancer
  9. Active herpes
  10. Bladder or lower ureteral calculi
  11. Waking frequency \<5 times in 12 hours
  12. Nocturia \<2 times
  13. Symptoms relieved by antibiotics, urinary antiseptics, urinary analgesics (for example phenazopyridine hydrochloride)
  14. Duration \< 12 months
  15. Involuntary bladder contractions (urodynamics)
  16. Capacity \> 400ml, absence of sensory urgency
* Automatic inclusions:

  1.Hunner's ulcer
* Positive factors: (two positive factors are necessary for inclusion)

  1. Pain on bladder filling relieved by emptying
  2. Pain (suprapubic, pelvic, urethral, vaginal or peripheral)
  3. Glomerulations on endoscopy
  4. Decreased compliance on cystometrogram
  5. Bladder distention is defined arbitrarily as 80 cm water pressure for 1 minute
* Use of Anticholinergic drugs, for the treatment of lower urinary tract symptoms who have an effect.
* Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up.
* Patients with bladder outlet obstruction on enrollment.
* Patients with urinary retention, PVR≥150 ml.
* Patients with uncontrolled confirmed diagnosis of acute urinary tract infection.
* Patients have laboratory abnormalities at screening including:

  1. Alanine aminotransferase (ALT) \> 3 x upper limit of normal range
  2. Aspartate aminotransferase (AST) \> 3 x upper limit of normal range.
  3. Patients have abnormal serum creatinine level \> 2 x upper limit of normal range.
* Can not be used in the treatment of patients with transurethral catheter treatment.
* Pregnant and lactating women or women who intend to become pregnant during the study or have myasthenia gravis, Eaton Lambert syndrome.
* Patients with any other serious disease or condition considered by the investigator not suitable for entry into the trial.
* Patients participated investigational drug trial within 1 month before entering this study.
* Written informed consent has been obtained.
* Patient who did not complete the 3-day micturition diary according to the instruction.
* Intestinal bladder augmentation patients receive angioplasty for the treatment of overactive bladder.
C: Inclusion Criteria:

* Chronic pelvic pain (\>6 months) perceived to be related to the urinary bladder and accompanied by urinary symptoms such as frequent urination during the day and/or night, and/or urgency to void
* Total score of 8 or greater on the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)
* The mean of the average pain intensity scores at screening phase \>=5 (on a scale of 0 to 10)
* Medically stable

Exclusion Criteria:

* Urinary culture is positive for a urinary tract infection; Recent invasive therapy to the bladder
* History or current conditions indicating that the bladder pain can be caused by diagnoses other than IC/PBS (eg, pain caused by a confirmed or suspected neoplasm)
* History of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been successfully treated
* Women who are pregnant or breast-feeding
* A body mass index (BMI) of \>39 kg/m2
D: 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

Answer: C