- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06193395
Translation and Validation of the ICIQ-B in Danish
Translation and Validation of the ICIQ-B in Danish Men and Women With Pelvic Floor Disorders
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Exclusion criteria
• Cognitive disabilities that cause inability to complete a questionnaire
After translation of the questionnaire by an expert panel, the investigators will perform interviews, pretesting and test-retest. Healthcare professionals will inform patients about the study and hand out written patient information containing a QR-code and a weblink to access the questionnaire in REDCap (Research Electronic Data Capture). Informed consent will be given electronically. No physical examination will be performed as part of this study.
The hypotheses are that the ICIQ-B can discriminate between patients suffering from AI from patients without AI and that it will correlate moderately with a widely used AI score (St Marks score).
The investigators will evaluate content validity with floor and ceiling effect, structural validity of the three subscales, convergent validity (by correlating the ICIQ-B scores with the St. Marks score) and discriminant validity by comparing subscale scores between patients with and without known AI. The study will also evaluate reliability by evaluating internal consistency of the ICIQ-B subscales
Statistics Descriptive statistics will be used to show distribution of data about gender, age, and diagnoses. Analyses to compare groups will be performed using non-parametric statistical analyses. A level of significance with a p-value of ≤0.05 will be used. The analyses will be performed in SPSS.
Ethical considerations All participants will receive oral and written information about the study and sign an informed consent. Permission to perform the study is given from the Danish Data Protection Agency (VD-2020-04). The Regional Ethics committee confirmed that no permission from the committee was needed, since the study does not involve treatment of patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Herlev, Denmark, 2870
- Hanna Jangö
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria
- ≥ 18 years of age
- Fluency in Danish
- Referred to a pelvic floor clinic or to an outpatient clinic for a pelvic floor disorder or a routine follow-up Exclusion criteria
- Cognitive disabilities that cause inability to complete a questionnaire
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients referred due to Pelvic Floor Disorders including anal incontinence
all patients with PFDs are eligible
|
No intervention, only clinical testing of questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 15-30 minutes to complete the questionnaire (with or without interview-time included)
|
translation into Danish
|
15-30 minutes to complete the questionnaire (with or without interview-time included)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VD-2020-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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