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临床试验/NCT06193395
NCT06193395已完成不适用

Translation and Validation of the ICIQ-B in Danish Men and Women With Pelvic Floor Disorders

Hanna Jangö2 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
238
试验地点
2
主要终点
Meaningful answers to single items and scores (ICIQ-B) in patients with and without anal incontinence and ability to discrimiante between groups of patients with and without anal incontinence

研究概览

简要总结

There are no validated scores in Danish revealing symptoms related to anal incontinence (AI). The International Consultation on Incontinence Questionnaire-Bowel (ICIQ-B) is an internationally recommended questionnaire that contains 21 items of which 17 are scored in three subscales: Bowel pattern; Bowel control and Quality of life. The aim was to translate and validate the ICIQ-B into Danish. The translation will be performed by a multidisciplinary team and the investigators will perform cognitive interviews and online testing of the questionnaire. The study only involves testing of a questionnaire and will not interfere with patient treatment.

详细描述

Background Anal incontinence (AI) is defined as the "complaint of involuntary loss of feces or flatus" and can significantly impact quality of life. Population studies have shown that 8-9% of adults suffer from AI with an equal distribution among men and women. There are different Patient Reported Outcome Measures (PROMs) regarding AI, but "the International Consultation on Incontinence Questionnaire Anal Incontinence Symptoms and Quality of Life Module" (ICIQ-B), first published in 2011, involved patients in the development of the questionnaire. The ICIQ-B is recommended by the International Consultation of Incontinence for both research and clinical use. There are no validated PROMs regarding AI in Danish, and therefore, the aim of this study was to translate and validate the ICIQ-B in Danish patients with pelvic floor disorders (PFD) with and without known AI.

Material and methods The ICIQ-B score contains 21 items and 17 of the 21 items are scored items. Each item is scored in an ordinal scale and each item contains a bother score rated on a numeric rank scale (NRS). The scored items are divided into three subscales covering: Bowel pattern (0-21), bowel control (0-28) and Quality of life (0-26) with a higher score indicating more symptoms.

We will recruit respondents from outpatient clinics in three hospitals in Denmark.

Inclusion criteria

  • ≥ 18 years of age
  • Fluency in Danish
  • Referred to a pelvic floor clinic or to an outpatient clinic for a PFD or a routine follow-up

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Meaningful answers to single items and scores (ICIQ-B) in patients with and without anal incontinence and ability to discrimiante between groups of patients with and without anal incontinence

时间窗: 15-30 minutes to complete the questionnaire (with or without interview-time included)

translation into Danish

次要结局

未报告次要终点

研究者

发起方
Hanna Jangö
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hanna Jangö

MD, PhD, Associate Professor

Herlev Hospital

研究点 (2)

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