title: Bladder pain syndrome: validation of simple tests for diagnosis in women with chronic pelvic pain: BRaVADO study protocol.
abstract: BACKGROUND
  Bladder pain syndrome (BPS), a condition with no gold standard diagnosis, comprises of a cluster of signs and symptoms. Bladder filling pain and bladder wall tenderness are two basic clinical features, present in a high number of sufferers. This study will validate the performance of these simple tests for BPS in women with chronic pelvic pain (CPP).
  
  
  METHODS
  We will conduct a prospective test validation study amongst women with unexplained CPP presenting to gynaecology outpatient clinics. Two index tests will be performed: patient reported bladder filling pain and bladder wall tenderness on internal pelvic bimanual examination. A final diagnosis of BPS will be made by expert consensus panel. We will assess the rates of index tests in women with CPP; evaluate the correlation between index tests and Pelvic Pain Urgency/ Frequency (PUF) questionnaire results; and determine index test sensitivity and specificity using a range of analytical methods. Assuming a 50% prevalence of BPS and an 80% power approximately 152 subjects will be required exclude sensitivity of < 55% at 70% sensitivity.
  
  
  CONCLUSIONS
  The results of this test validation study will be used to identify whether a certain combination of signs and symptoms can accurately diagnose BPS.
authors.affiliation: Women's Health Research Unit, Barts and the London School of Medicine, Queen Mary, University of London, 58 Turner Street, London E1 2AB, UK. s.a.tirlapur@qmul.ac.uk.
authors.forename: Seema A
authors.initials: SA
authors.lastname: Tirlapur
authors.forename: Lee
authors.initials: L
authors.lastname: Priest
authors.forename: Daniel
authors.initials: D
authors.lastname: Wojdyla
authors.forename: Khalid S
authors.initials: KS
authors.lastname: Khan
mesh_terms: D000293:Adolescent; D000328:Adult; D002985:Clinical Protocols; D018856:Cystitis, Interstitial / Q000175:diagnosis*; D005260:Female; D006801:Humans; D017699:Pelvic Pain / Q000175:diagnosis*; D011446:Prospective Studies; D011795:Surveys and Questionnaires