Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi-Center, Double-Blind, Placebo-Controlled Investigation of Silodosin in the Treatment of Subjects With Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Brief Summary: The primary objective is to compare the efficacy of silodosin 4 and 8 mg once daily with placebo in the treatment of subjects with moderate to severe abacterial chronic prostatitis/chronic pelvic pain syndrome during a 12 week treatment period. The secondary objective is to compare the safety of silodosin 4 and 8 mg once daily with placebo.


Options:
A: Inclusion Criteria:

* Diagnosis of category IIIa of IIIb chronic prostatitis
* NIH-CPSI (National Institute of Health Chronic Prostatitis Symptom Index) score ≥ 15

Exclusion Criteria:

* Urinary tract infection or uropathogen within the past 12 months
* Serious medical problems
* NIH consensus exclusion criteria13 (presence of active urethritis, urogenital cancer, urinary tract disease, functionally significant urethral stricture, neurological disease affecting the bladder, etc.)
* Drug therapy that might affect lower urinary tract functions within the past 3 months
B: 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
C: Inclusion Criteria:

* Participant has signed and dated the appropriate Informed Consent document.
* Participant is male.
* Participant is at least 18 years of age.
* Participant has had symptoms of discomfort or pain in the pelvic region for at least a six-week interval at the time of presentation.
* Symptoms bothersome enough to prompt a physician visit have been present for two years or less.

Exclusion Criteria:

* Participant has evidence of facultative Gram negative or enterococcus with a value of greater than or equal to 1000 colony forming units (CFU) /ml in mid-stream urine (VB2).
* Participant has previously received alfuzosin (Uroxatral®), tamsulosin hydrochloride (Flomax®), doxazosin mesylate (Cardura®), terazosin hydrochloride (HCL) (Hytrin®), or other alpha-adrenergic receptor blockers for symptoms of CP/CPPS or within the past two years for any other reason.
* Participant has a history of prostate, penile, testicular, bladder, or urethral cancer or has undergone pelvic radiation, systemic chemotherapy, or intravesical chemotherapy.
* Participant has a history of moderate or severe hepatic impairment, severe renal sufficiency, severe or unstable cardiovascular (i.e. prolonged QT), respiratory, hematological, endocrinological, neurological or other somatic disorders.
* Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture, or neurological disease or disorder affecting the bladder.
* Participant has uninvestigated, significant hematuria.
* Participant has undergone transurethral prostatectomy (TURP), transurethral incision of the prostate (TUIP), transurethral Incision or Resection of the Bladder Neck (TUIBN), transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation of the prostate, open prostatectomy or any other prostate surgery or treatment such as cryotherapy or thermal therapy.
* Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
* Participant is currently taking exclusionary medications such as potent CYP3A4 inhibitors (i.e. ketoconazole, itraconazole, or ritonavir) or erythromycin.
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: D