Clinically Important Differences for Pain and Urinary Symptoms in Urological Chronic Pelvic Pain Syndrome: A MAPP Network Study.
Clinically Important Differences for Pain and Urinary Symptoms in Urological Chronic Pelvic Pain Syndrome: A MAPP Network Study.
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泌尿科慢性盆腔疼痛综合征中疼痛和泌尿症状的临床重要差异：MAPP 网络研究。
DOI：
10.1097/ju.0000000000003394
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发表时间：
2023
期刊：
影响因子：
--
通讯作者：
Gupta,P
中科院分区：
文献类型：
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作者：
Stephens-Shields,AlisaJ;Lai,HHenry;Landis,JRichard;Kreder,Karl;Rodriguez,LarissaV;Naliboff,BruceD;Afari,Niloofar;Sutcliffe,Siobhan;Moldwin,Robert;Griffith,JamesW;Clemens,JQuentin;Bradley,CatherineS;Quallich,Susan;Gupta,P
目的间质性膀胱炎/膀胱疼痛综合征和慢性前列腺炎/慢性盆腔疼痛综合征（统称为泌尿科慢性盆腔疼痛综合征）的症状异质性导致难以确定适当的临床试验终点。我们确定了两种主要症状测量（盆腔疼痛严重程度和泌尿系统症状严重程度）的临床重要差异，并评估亚组差异。材料和方法慢性盆腔疼痛症状模式研究的多学科方法研究纳入了患有泌尿科慢性盆腔疼痛综合征的个体。我们通过将 3 至 6 个月内盆腔疼痛严重程度和泌尿系统症状严重程度的变化与使用回归和受试者工作特征曲线进行的总体反应评估的显着改善联系起来，定义了临床上重要的差异。我们评估了绝对变化和百分比变化的临床重要差异，并通过性别诊断、Hunner 病变的存在、疼痛类型、疼痛广泛性和基线症状严重程度检查了临床重要差异的差异。结果 -4 的绝对变化在所有患者中盆腔疼痛严重程度方面具有临床重要意义，但临床重要差异估计因疼痛类型、Hunner 病变的存在和基线严重程度而异。盆腔疼痛严重程度的临床重要差异百分比变化估计在各亚组中更加一致，范围为 30% 至 57%。仅患有慢性前列腺炎/慢性盆腔疼痛综合征的女性参与者的泌尿症状严重程度的绝对变化临床重要差异为-3，而男性参与者的绝对变化为-2。基线严重程度较高的患者需要症状明显减轻才能感觉改善。在基线症状较低的参与者中，估计的临床重要差异的准确性较低。 结论 盆腔疼痛严重程度降低 30%-50% 是泌尿科慢性盆腔疼痛综合征未来治疗试验的一个有临床意义的终点。对于男性和女性参与者分别定义泌尿症状严重程度的临床重要差异更合适。
PurposeSymptom heterogeneity in interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome, collectively termed urological chronic pelvic pain syndrome, has resulted in difficulty in defining appropriate clinical trial endpoints. We determine clinically important differences for 2 primary symptom measures, pelvic pain severity and urinary symptom severity, and evaluate subgroup differences.Materials and MethodsThe Multidisciplinary Approach to the Study of Chronic Pelvic Pain Symptom Patterns Study enrolled individuals with urological chronic pelvic pain syndrome. We defined clinically important differences by associating changes in pelvic pain severity and urinary symptom severity over 3 to 6 months with marked improvement on a global response assessment using regression and receiver operating characteristic curves. We evaluated clinically important differences for absolute and percent change and examined differences in clinically important differences by sex-diagnosis, presence of Hunner lesions, pain type, pain widespreadness, and baseline symptom severity.ResultsAn absolute change of −4 was clinically important in pelvic pain severity among all patients, but clinically important difference estimates differed by pain type, presence of Hunner lesions, and baseline severity. Pelvic pain severity clinically important difference estimates for percent change were more consistent across subgroups and ranged from 30% to 57%. The absolute change urinary symptom severity clinically important difference was −3 for female participants and −2 for male participants with chronic prostatitis/chronic pelvic pain syndrome only. Patients with greater baseline severity required larger decreases in symptoms to feel improved. Estimated clinically important differences had lower accuracy among participants with low baseline symptoms.ConclusionsA reduction of 30%-50% in pelvic pain severity is a clinically meaningful endpoint for future therapeutic trials in urological chronic pelvic pain syndrome. Urinary symptom severity clinically important differences are more appropriately defined separately for male and female participants.