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. Author manuscript; available in PMC: 2015 Dec 1.
Published in final edited form as: BJU Int. 2014 Aug 11;114(6):916–925. doi: 10.1111/bju.12778

Eligibility criteria for the Trans-Multidisciplinary Approaches to the Study of Chronic Pelvic Pain (MAPP) Epidemiology and Phenotyping Study

Inclusion criteria

  1. Has signed and dated the appropriate informed consent document:

    1. Has agreed to participate in the Trans-MAPP Epidemiology and Phenotyping Study procedures.

    2. Has given permission for use of DNA for genes related to the main goals of the study.

  2. Is 18 years of age or older.

  3. Reports a response of at least one on a 0-10 point scale assessing average pain, pressure, and discomfort associated with the bladder/prostate and/or pelvic region in the past two weeks.

  4. (Interstitial cystitis/bladder pain syndrome (IC/BPS) criteria for female and male participants) Reports 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.

    1. These IC/BPS symptoms must have been present for the majority of the time during any three months in the previous six months and;

    2. These IC/BPS symptoms must have been present for the majority of the time during the most recent three months.

  5. (Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) criteria for male participants) Reports pain or discomfort in any of the following: perineum, testicles, tip of penis, below the waist, with urination, with ejaculation, with bladder filling, or relieved by voiding.

    1. These CP/CPPS symptoms must have been present for the majority of the time during any three months in the previous six months.

Exclusion criteria

  1. Has an on-going symptomatic urethral stricture.

  2. Has an on-going neurological disease or disorder affecting the bladder or bowel fistula.

  3. Has a history of cystitis caused by tuberculosis, radiation therapy, or Cytoxan/cyclophosphamide therapy.

  4. Has undergone augmentation cystoplasty or cystectomy.

  5. Has an active autoimmune or infectious disorder (such as Crohn's disease or ulcerative colitis, lupus, rheumatoid arthritis, multiple sclerosis, or HIV).

  6. Has a history of cancer (with the exception of skin cancer).

  7. Has a current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g., dementia, psychosis, upcoming major surgery, etc.).

  8. Has severe cardiac, pulmonary, renal, or hepatic disease that, in the judgment of the study physician, would preclude participation in the study.

  9. [Male participants only] Has been diagnosed with unilateral orchalgia without pelvic symptoms.

  10. [Male participants only] Has a history of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, prostate cryo-surgery, or laser procedure.

Deferral criteria

  1. If the potential participant has had definitive treatment for acute epididymitis, urethritis, or vaginitis, he/she will be deferred for at least three months from resolution of symptoms.

  2. If the potential participant has a history of unevaluated hematuria, he/she will be deferred until the hematuria is evaluated.

  3. If the potential participant has an abnormal dipstick urinalysis confirming abnormal levels of nitrites and has a positive 48 hour urine culture, he/she will be deferred for three months.

  4. [Male participants only] If the potential participant has had a prostate biopsy or transurethral resection of the prostate (TURP) within the last three months, he will be deferred for three months following prostate biopsy or TURP.

  5. [Female participants only] If the potential participant has a positive urine pregnancy test, she will be deferred until after delivery.