Bladder pain syndrome: validation of simple tests for diagnosis in women with chronic pelvic pain: BRaVADO study protocol

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Colleges, School and Institutes


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/DESIGN: 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.

DISCUSSION: The results of this test validation study will be used to identify whether a certain combination of signs and symptoms can accurately diagnose BPS.


Original languageEnglish
Pages (from-to)61
JournalReproductive Health
Issue number1
Publication statusPublished - 2013


  • Adolescent, Adult, Clinical Protocols, Cystitis, Interstitial, Female, Humans, Pelvic Pain, Prospective Studies, Questionnaires