膀胱抗毒蕈碱药物和意外肠漏 (BAMA)
治疗双尿失禁女性急迫性尿失禁的抗毒蕈碱药物(达非那新用于治疗双尿失禁女性)
研究概览
详细说明
急迫性尿失禁 (UUI) 和大便失禁 (FI) 是两种非常普遍的盆底疾病,会对生活质量 (QOL) 产生负面影响。 在患有急迫性尿失禁 (UUI) 的女性中,8-20% 的人也患有尿失禁。
UUI 和 FI 的初始管理包括行为疗法,有或没有药物管理。 FI 的一线管理包括饮食、液体和纤维摄入量调整(A 级)、止泻药(B 级)和锻炼以加强和提高对肛门括约肌的认识(C 级)。 如果这些措施在 8-12 周后症状仍未改善,则应考虑进一步调查,然后再转向更具侵入性的治疗方案,例如填充剂、括约肌成形术或骶神经刺激。
除了纤维和止泻药外,具有抗毒蕈碱作用的药物(例如天仙子胺和三环类抗抑郁药)也常用于治疗 FI 和 IBS-D。 在这种情况下,抗毒蕈碱药物通过阻断结肠毒蕈碱乙酰胆碱受体发挥作用,导致平滑肌松弛、肠道蠕动降低和结肠转运时间延长。
对于患有 UUI 的膀胱过度活动症 (OAB) 患者,可以将抗毒蕈碱药物或 β3-肾上腺素受体激动剂药物添加到行为疗法中作为一线,以优化症状控制和 QOL (Gormley 2015)。 在接受 UUI 治疗的患者中,便秘通常被视为抗毒蕈碱药物的不良副作用,不同药物的便秘发生率不同。 非选择性抗毒蕈碱药物,如非索罗定 (Toviaz®) 和托特罗定 (Detrol®) 可能不太可能引起便秘,而较新的 M2 或 M3 选择性药物,如达非那新 (Enablex®)、索利芬新 (Vesicare®) 或 trospium ( Sanctura ®) 可能更容易便秘。 达非那新以最高的便秘率而著称——7.5 毫克剂量高达 15%,15 毫克剂量高达 21%。
虽然目前没有证据表明在患有双重尿失禁(特别是 UUI 和 FI)的患者中使用一种特定的抗毒蕈碱药物,但许多提供者在这种情况下使用更便秘的抗毒蕈碱药物作为治疗。 以稀便为主的 FI 患者可能会因结肠传输时间减慢、排便更结实而从便秘副作用中获益,从而改善与肠道相关的 QOL。 之前只有一项研究检查了 OAB 的抗毒蕈碱药物对肠道相关 QOL 的影响。 在这项描述性研究中,对 90 名接受抗毒蕈碱药物治疗 OAB 的患者进行了随访,以测量 ePAQ(电子个人评估问卷)评分的变化。 研究人员报告说,治疗后三到六个月,与肠道相关的 QOL 显着改善。 作者没有具体说明治疗前的诊断、症状或抗毒蕈碱治疗的细节。
虽然据传抗毒蕈碱药物是双重尿失禁患者的有效一线药物,但仍需要更多证据。 因此,我们研究的目的是观察针对 UUI 的标准抗毒蕈碱治疗对双重失禁女性大便失禁症状的影响。 研究人员将比较患者报告的大便失禁症状在选择接受 UUI 标准护理医疗管理和抗毒蕈碱药物达非那新的双重失禁女性治疗前后的症状。
假设:在双尿失禁患者中,使用达非那新 7.5mg 治疗急迫性尿失禁将在 8 周时改善 FI 症状的严重程度8周
次要目标:
次要目标 #1:使用 7 天排便日记来表征治疗后 FI 频率的变化、生活质量的变化(大便失禁生活质量 (FIQOL) 总分和子量表分数的变化),并使用 Patient全球改善印象 (PGI-I) 衡量次要目标 #2:描述双尿失禁患者抗毒蕈碱药物的依从性和副作用。
次要目标 #3:使用 OAB 问卷简表 (OAB-q SF) 描述抗毒蕈碱药物对双重尿失禁患者 OAB 症状困扰和生活质量的影响
研究类型
注册 (实际的)
联系人和位置
学习地点
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Alabama
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Birmingham、Alabama、美国、35233
- UAB Kirklin Clinic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
纳入标准:
- 到 UAB 泌尿妇科和失禁诊所就诊并同时发生 UUI 和 FI 的女性 ≥18 岁
- 愿意完成所有与学习相关的项目
排除标准:
- 严重便秘、粪便嵌塞或溢流性大便失禁
- 炎症性肠病、结直肠癌、脊髓损伤、多发性硬化症、中风、重症肌无力
- 感染性腹泻
- 烦人的 SUI(在 UDI-3 上定义为“中度”或更烦人)
- 计划在研究期间接受手术的患者
- 研究期间怀孕或打算怀孕的患者
- 有抗毒蕈碱药物禁忌症的患者(即 闭角型青光眼)
- 在过去 14 天内使用不稳定或不断变化的纤维或麻醉剂剂量的患者
- 每天服用超过 2mg 洛哌丁胺的患者(服用超过 2mg 的患者需要 2 周的清除期)
- 目前正在服用急迫性尿失禁药物的患者(这些患者还需要 2 周的清除期)
- 在研究期间接受骨盆底物理治疗师治疗的患者
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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FI 症状严重程度的变化
大体时间:8周
|
通过问卷和排便日记进行测量 所使用的问卷是测量大便失禁严重程度的 Vaizey 量表。 最低分数为 0(完全失禁;最佳),最高分数为 24(完全失禁;更差)。 没有分量表。 排便日记是对患者每次排便的为期一周的记录。 没有标准化的评分或量表。 |
8周
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
治疗后 FI 频率的变化
大体时间:8周
|
通过排便日记测量 排便日记是对患者每次排便的为期一周的记录。 没有标准化的评分或量表。 |
8周
|
合作者和调查者
合作者
调查人员
- 首席研究员:Lindsay M Kissane, MD、University of Alabama at Birmingham
出版物和有用的链接
一般刊物
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- Abrams P, Andersson KE, Birder L, Brubaker L, Cardozo L, Chapple C, Cottenden A, Davila W, de Ridder D, Dmochowski R, Drake M, Dubeau C, Fry C, Hanno P, Smith JH, Herschorn S, Hosker G, Kelleher C, Koelbl H, Khoury S, Madoff R, Milsom I, Moore K, Newman D, Nitti V, Norton C, Nygaard I, Payne C, Smith A, Staskin D, Tekgul S, Thuroff J, Tubaro A, Vodusek D, Wein A, Wyndaele JJ; Members of Committees; Fourth International Consultation on Incontinence. Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourol Urodyn. 2010;29(1):213-40. doi: 10.1002/nau.20870. No abstract available.
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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