Translation and Validation of the ICIQ-B in Danish

NCT06193395 | Completed

• 1 other identifier: VD-2020-04
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Anal Incontinence; Pelvic Floor Disorders; Quality of Life; Anal Sphincter Tear

Outcome Measures

Primary Outcomes (1)

• 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

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

Study Arms (1)

Patients referred due to Pelvic Floor Disorders including anal incontinence

EXPERIMENTAL

all patients with PFDs are eligible

Other: Questionnaire

Interventions

Questionnaire OTHER

No intervention, only clinical testing of questionnaire

Patients referred due to Pelvic Floor Disorders including anal incontinence

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age
• Fluency in Danish

You may not qualify if:

• Cognitive disabilities that cause inability to complete a questionnaire

Sponsors & Collaborators

• Hanna Jangö: lead

Study Sites (1)

Hanna Jangö

Herlev, 2870, Denmark

Location

MeSH Terms

Conditions

Encopresis; Pelvic Floor Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: January 5, 2024
• Study Start: October 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)