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

机译:膀胱疼痛综合征:慢性盆腔疼痛女性的简单检查诊断方法的验证:BRaVADO研究方案

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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 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. Trial registration ISRCTN13028601
机译:背景膀胱疼痛综合征(BPS)是一种没有金标准诊断的疾病,由一系列症状和体征组成。膀胱充盈痛和膀胱壁压痛是两个基本临床特征,存在于许多患者中。这项研究将验证这些简单的BPS测试在慢性盆腔痛(CPP)妇女中的表现。方法/设计我们将在妇产科门诊就诊的原因不明的CPP妇女中进行前瞻性测试验证研究。将进行两项指标测试:病人在进行内部盆腔双手检查时报告的膀胱充盈疼痛和膀胱壁压痛。 BPS的最终诊断将由专家共识小组做出。我们将评估CPP妇女的指数测试率;评估指标测试与骨盆疼痛迫切性/频率(PUF)问卷结果之间的相关性;并使用多种分析方法确定指标测试的敏感性和特异性。假设需要BPS的50%患病率和80%的能力约152名受试者,但不包括讨论的敏感性。该测试验证研究的结果将用于识别某些体征和症状组合是否可以准确诊断BPS。试用注册ISRCTN13028601

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