Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
238 participants
INTERVENTIONAL
2020-10-01
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients referred due to Pelvic Floor Disorders including anal incontinence
all patients with PFDs are eligible
Questionnaire
No intervention, only clinical testing of questionnaire
Interventions
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Questionnaire
No intervention, only clinical testing of questionnaire
Eligibility Criteria
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Inclusion Criteria
* Fluency in Danish
Exclusion Criteria
ALL
No
Sponsors
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Hanna Jangö
OTHER
Responsible Party
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Hanna Jangö
MD, PhD, Associate Professor
Locations
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Hanna Jangö
Herlev, , Denmark
Countries
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Other Identifiers
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VD-2020-04
Identifier Type: -
Identifier Source: org_study_id
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