Table 1.

Inclusion and exclusion criteria

Inclusion criteria:

(1) males or females at least 18 years of age

(2) ability to provide written, informed consent

(3) a response of at least 1 on a pain, pressure or discomfort scale (0 to 10) perceived to be related to the bladder/prostate and/or pelvic region

(4) fulfilled one of the following MAPP symptom criteria (IC/BPS and/or CP/CPPS):

To meet the MAPP IC/BPS symptom criteria, males* or females had to report an unpleasant sensation of pain, pressure or discomfort, perceived to be related to the bladder and/or pelvic region, associated with lower urinary tract symptoms. The IC/BPS symptoms must be present for the majority of the time during any 3 months in the previous 6 months, and have been present for the majority of the time during the most recent 3 months.

To meet the MAPP CP/CPPS symptom criteria (males* only), males had to report pain or discomfort in any of the 8 Male Genitourinary Pain Index (GUPI) pain domains. In addition, these CP/CPPS symptoms had to have been present for the majority of the time during any 3 months in the previous 6 months.

*Males may enter the MAPP study through IC/BPS and/or CP/CPPS symptom criteria.

Exclusion criteria:

(1) on-going symptomatic urethral stricture, (2) on-going neurological disease or disorder affecting the bladder, (3) bowel fistula, (4) a history of cystitis caused by tuberculosis, radiation therapy, or cytoxan/cyclophosphamide therapy, (5) augmentation cystoplasty or cystectomy, (6) a history of cancer except skin cancer, (7) active Crohn's disease, ulcerative colitis, systemic lupus erythematosis, rheumatoid arthritis, multiple sclerosis, human immunodeficiency virus infection, (8) current major psychiatric disorder or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery), (9) severe cardiac, pulmonary, renal, or hepatic disease that in the physician's judgment would preclude participation. Males were also excluded for: (10) unilateral orchalgia without pelvic symptoms, (11) history of transurethral microwave thermotherapy, transurethral needle ablation or balloon dilation of the prostate, prostate cryosurgery, or laser prostate procedure.

Deferral criteria:

(1) definitive treatment for acute epididymitis, urethritis or vaginitis in the past 3 months, (2) unevaluated hematuria, (3) a history of prostate biopsy or transurethral resection of the prostate in the past 3 months, (4) positive urine pregnancy test.