Functional Outcomes of the Miami Pouch Continent Cutaneous Urinary Diversion: A Quality of Life Study (MiaDIG)
Functional Urinary and Digestive Outcomes After Miami Pouch: A Quality-of-Life Study (MIADIG)
The Miami Pouch is a continent cutaneous urinary diversion using the plicated right colon and the ileocecal valve as a catheterizable continent stoma. Despite its long history, functional outcomes remain poorly reported, with no consensus on continence definition or standardized assessment tools.
This single-center cross sectional cohort study evaluates functional outcomes in patients who underwent Miami Pouch urinary diversion at Hôpital Lyon Sud (Hospices Civils de Lyon, France) between 2015 and 2025. Patients were identified through institutional medical coding (PMSI) and contacted by telephone to complete validated patient-reported outcome measures.
The primary objective is to assess stomal continence using the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF).
Hypothesis: The Miami Pouch provides acceptable long-term stomal continence with limited impact on digestive function.
研究概览
地位
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Théo ARBER, MD
- 电话号码：+33 04 72 67 88 37
- 邮箱：Theo.Arber@chu-lyon.fr
研究联系人备份
- 姓名：Cyril VITARD, MD
- 电话号码：+33 04 72 67 88 37
- 邮箱：Cyril.vitard@chu-lyon.fr
学习地点
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Pierre-Bénite、法国、69310
- Hôpital Lyon Sud
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接触：
- Théo ARBER, MD
- 电话号码：+33 04 72 67 88 37
- 邮箱：Theo.Arber@chu-lyon.fr
-
接触：
- Cyril VITARD, MD
- 电话号码：+33 04 72 67 88 37
- 邮箱：Cyril.vitard@chu-lyon.fr
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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
Consecutive patients who underwent Miami Pouch continent cutaneous urinary diversion at the Urology Department of Hôpital Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France, between 2015 and 2025. 35 patients estimation.
Patients identification through institutional surgical coding (PMSI) and contacted by phone for study participation
描述
Inclusion Criteria:
- Adult patients aged 18 years or older
- Miami Pouch continent cutaneous urinary diversion performed at Lyon Sud Hospital (HCL) between January 2015 and December 2025
- Minimum postoperative follow-up of 6 months
- No opposition to participation in the study
Exclusion Criteria:
- Patient deceased at time of study contact
- Patient unreachable or unavailable after three contact attempts
- Opposition to participation or to personal data processing
- Postoperative follow-up of less than 6 months
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：CROSS_SECTIONAL
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Miami pouch
Adult patients who underwent Miami Pouch continent cutaneous urinary diversion at the Urology Department of Hôpital Lyon Sud (HCL) between 2015 and 2025, with a minimum postoperative follow-up of 6 months |
Patients completed four validated questionnaires by telephone: the ICIQ-SF (urinary symptom frequency and impact), the SF-Qualiveen (urinary quality of life in neurogenic and non-neurogenic patients), a modified 20-item Gastrointestinal Quality of Life Index (digestive quality of life), and the Bristol Stool Scale (stool consistency) Patients performed a self-administered 24-hour stomal pad test at home. Absorbent pads were weighed before and after placement over the stoma. Total pad weight gain (grams) over 24 hours was used as an objective measure of stomal urinary leakage. |
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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Stomal Continence Rate
大体时间：6 months post-surgery
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Stomal continence classified into three categories based on ICIQ-SF questionnaire :
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6 months post-surgery
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合作者和调查者
调查人员
- 首席研究员：ARBER Théo, MD、Hospices Civils de Lyon
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
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
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 69HCL26_0869
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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