Abstract
BackgroundBladder 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/designWe 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.DiscussionThe results of this test validation study will be used to identify whether a certain combination of signs and symptoms can accurately diagnose BPS.Trial registrationISRCTN13028601
Highlights
Bladder pain syndrome (BPS), a condition with no gold standard diagnosis, comprises of a cluster of signs and symptoms
The results of this test validation study will be used to identify whether a certain combination of signs and symptoms can accurately diagnose BPS
Regular data monitoring committee meetings will be scheduled with a group of independent experts. The results of this test validation study will be used to identify whether a certain combination of signs and symptoms can accurately predict the diagnosis of BPS
Summary
Bladder pain syndrome (BPS), a condition with no gold standard diagnosis, comprises of a cluster of signs and symptoms. This study will validate the performance of these simple tests for BPS in women with chronic pelvic pain (CPP). The condition has a large impact on sexual function and quality of life [6]. It has an unknown aetiology and imprecise characterisation, which makes it difficult to accurately. The most commonly reported symptoms are bladder/ pelvic pain, urgency, frequency and nocturia but this symptom cluster is present in several other urinary conditions. Yes. Is there a single reference standard providing adequate classification?. No the reference standard be available in all study participants?
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