Anal IncontinenceNCT06193395
Translation and Validation of the ICIQ-B in Danish
A study testing Questionnaire in people with Anal Incontinence and Pelvic Floor Disorders, run by Hanna Jangö at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anal Incontinence, Pelvic Floor Disorders, Quality of Life
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translation and Validation of the ICIQ-B in Danish Men and Women With Pelvic Floor Disorders
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.
Read the 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.
- Being tested
- Questionnaire
- Medical subject headings
- Encopresis, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
No intervention, only clinical testing of questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Patients referred due to Pelvic Floor Disorders including anal incontinence | Experimental | all patients with PFDs are eligible Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
translation into Danish
Measured: 15-30 minutes to complete the questionnaire (with or without interview-time included)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Oct 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanna Jangö
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hanna Jangö, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193395
- Sponsor's protocol ID
- VD-2020-04
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of the ICIQ-B in Danish Men and Women With Pelvic Floor Disorders
- ClinicalTrials.gov ID
- NCT06193395
- Acronym / sponsor ID
- VD-2020-04
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Hanna JangöUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred due to Pelvic Floor Disorders including anal incontinence | Experimental | Other: Questionnaireall patients with PFDs are eligible |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireNo intervention, only clinical testing of questionnaire | Other | Patients referred due to Pelvic Floor Disorders including anal incontinence |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Anal Incontinence and Pelvic Floor Disorders, run by Hanna Jangö at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.