Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Pregabalin for the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Brief Summary: The purpose of this study is to determine whether pregabalin is an effective treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome.


Options:
A: Inclusion Criteria:

* female and male patients who have failed to respond to previous therapies for interstitial cystitis/painful bladder syndrome
* male patients who have failed to respond to previous therapies for chronic prostatitis/chronic pelvic pain syndrome

Exclusion Criteria:

* neurologic disorder affecting bladder
* bladder cancer, prostate cancer, or urethral cancer
B: Inclusion criteria:

* Informed consent to participate in study.
* Have had a single negative prostate biopsy within 6 months prior to enrollment in study.
* Have a PSA (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or a PSA between 3.0 and 10 if over age 60.
* Ability and will to participate in study for 4 years.

Exclusion criteria:

* More than one previous negative prostate biopsy.
* History of prostate cancer.
* Previous prostate surgery.
* Inability to urinate requiring the need of a catheter during the previous 2 years.
* Any condition (other than benign prostatic hypertrophy) which may result in urinary symptoms or changes in urine flow rate.
* Cancer within previous 5 years (other than basal or squamous cell cancers of the skin).
* Any unstable serious medical condition.
* Use within the past 12 months of finasteride (Proscar or Propecia), dutasteride (Avodart), testosterone, or drugs that can block the action of male hormones.
C: Inclusion Criteria:

* Participant has signed and dated the appropriate Informed Consent document.
* Participant must have had symptoms of discomfort or pain in the pelvic region for at least a three (3) month period within the last six (6) months.

Exclusion Criteria:

* Participant has continued evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 and ≤ 100,000 CFU/ml in mid-stream urine (VB2), as demonstrated by repeat culture obtained no less than seven (7) days post antibiotic treatment.
* Participant has a calculated creatinine clearance of \<60 mL/min.
* Participant has a platelet count \<100,000/mm3.
* Participant is allergic to antiepileptic/antiseizure medications.
* Participant has a known allergy or sensitivity to pregabalin (Lyrica®).
* Participant is taking thiazolidinedione antidiabetic agents (i.e. rosiglitazone and pioglitazone).
* Participant has New York Heart Association Class III or IV congestive heart failure.
* Participant has a history of thrombocytopenia, or a bleeding diathesis.
* Participant has a history of prostate, bladder or urethral cancer.
* Participant has a history of alcohol abuse.
* Participant has inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome).
* Participant has undergone pelvic radiation or systemic chemotherapy.
* Participant has undergone intravesical chemotherapy.
* Participant has been treated with intravesical BCG.
* Participant has unilateral orchalgia without other pelvic symptoms.
* Participant has an active urethral stricture.
* Participant has a neurological disease or disorder affecting the bladder.
* Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
D: Inclusion Criteria:

* Male, at least 18 years of age
* Has a total NIH-CPSI total score of 15
* Has a NIH-CPSI pain score of 8
* Has had pain in the pelvic region for at least 3 months prior to screening

Exclusion Criteria:

* Has previously participated in a Watson study with silodosin
* Has previously received α-blocked therapy for chronic prostatitis/chronic pelvic pain syndrome or is currently receiving α-blocked therapy for any condition
* Has experience ≥2 urinary tract infections within the previous 12 months
* Has any medical condition that in the opinion of the investigator precludes safe participation in the study
* Has any medical condition that could confound the efficacy evaluation
* Is receiving ketoconazole, or other known potent inhibitors of cytochrome P450 3A4 or any medication in the opinion of the investigator that precludes safe participation in the study
* Is receiving any medication that in the opinion of the investigator that could confound the efficacy evaluation
* Has participated in a study involving the administration of an investigational agent within the past 30 days

Answer: C