Tirlapur Seema A, Priest Lee, Wojdyla Daniel, Khan Khalid S
Women's Health Research Unit, Barts and the London School of Medicine, Queen Mary, University of London, 58 Turner Street, London E1 2AB, UK.
Reprod Health. 2013 Dec 4;10(1):61. doi: 10.1186/1742-4755-10-61.
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.
The results of this test validation study will be used to identify whether a certain combination of signs and symptoms can accurately diagnose BPS.
膀胱疼痛综合征（BPS）是一种尚无金标准诊断方法的疾病，由一系列体征和症状组成。膀胱充盈疼痛和膀胱壁压痛是两个基本临床特征，在大量患者中存在。本研究将验证这些简单检查对慢性盆腔疼痛（CPP）女性患者BPS的诊断效能。
方法/设计：我们将对到妇科门诊就诊的不明原因CPP女性患者进行一项前瞻性检查验证研究。将进行两项指标检查：患者自述的膀胱充盈疼痛和盆腔双合诊时的膀胱壁压痛。最终诊断将由专家共识小组做出。我们将评估CPP女性患者中指标检查的发生率；评估指标检查与盆腔疼痛尿急/频率（PUF）问卷结果之间的相关性；并使用一系列分析方法确定指标检查的敏感性和特异性。假设BPS患病率为50%，检验效能为80%，约需152名受试者以排除敏感性低于55%时70%的敏感性。
本检查验证研究的结果将用于确定某些体征和症状的特定组合是否能准确诊断BPS。
