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NCT Number: NCT06423222

Anal Incontinence and Its Impact on Quality of Life and Physical Activity Among Hungarian Women and the Hungarian Language Validation of the International Consultation on Incontinence Modular Questionnaire-Bowels (ICIQ-B)

The aim of the study is to assess the prevalence of anal incontinence among Hungarian women who have given birth at least once before, and to examine the impact of anal incontinence on the quality of life and physical activity of these women. A further aim of our study is to adapt the Hungarian version of the International Consultation on Incontinence Modular Questionnaire - Bowels (ICIQ-B) and to assess its validity and reliability.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Doctoral School of Health Sciences, Faculty of Health Sciences, University of Pécs

Pécs, Baranya, H-7621, Hungary

Location status: Recruiting

Location contact

Márta Hock, Phd

CONTACT

[email protected]

+36-30-7213156

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have given birth at least once before
  • Native Hungarian language

Exclusion criteria

  • Menopause
  • Irritable Bowel Syndrome (IBS)
  • Chron's disease
  • Ulcerative colitis
  • Developmental abnormalities at the level of the pelvic organs
  • Uninvestigated pelvic pain
  • Malignant pelvic tumor
  • Radiotherapy involving the pelvis
  • Neurological diseases with muscle weakness
  • Parkinson's disease
  • Intellectual disability

Treatment and study plan

Primary outcomes

  1. Anal Incontinence Impact on Quality of Life

    Time frame: Through study completion, an average of 3 years

    Assessing with questionnaire: International Consultation on Incontinence Modular Questionnaire-Bowels (ICIQ-B). The ICIQ-B is a patient-completed questionnaire to assess the symptoms and impact on quality of life (QoL) of anal incontinence (including flatus incontinence). The ICIQ-B consists of 21 items, divided into three domains: Bowel pattern (1 - 21), bowel control (0 - 28), Quality of life (0 - 26). Seventeen items are scored items and the remaining four are unscored. Higher scores indicate more symptoms.

  2. Anal Incontinence Impact on Physical Activity

    Time frame: Through study completion, an average of 3 years

    Assessing with questionnaire: Global Physical Activity Questionnaire (GPAQ). The Global Physical Activity Questionnaire was developed by WHO to monitor physical activity in countries. It collects information from 16 questions (P1-P16) on participation in physical activity in three domains (Workplace activity, Travel to and from places, Leisure activities) and sedentary behavior. Metabolic equivalent (MET) values are applied to the time variables according to the intensity of the activity (moderate or high). The application of MET values to activity levels allows the calculation of total physical activity.

  3. Adaptation, validity and reliability of the Hungarian version of the International Consultation on Incontinence Modular Questionnaire-Bowels (ICIQ-B)

    Time frame: Through study completion, an average of 3 years

    Evaluating with statistical analysis the content/face validity, internal consistency, construct validity, test-retest reproducibility, discriminant validity and convergent validity.

Secondary outcomes

  1. Additional pelvic floor symptoms

    Time frame: Through study completion, an average of 3 years

    Assessing with questionnaire: The Hungarian version of the Australian Pelvic Floor Questionnaire (APFQ-H). The APFQ-H consists of four domains: bladder function (15 items), bowel function (12 items), prolapse symptoms (5 items) and sexual function (10 items). Thirty-eight of the items assess pelvic floor symptoms and four questions assess the bother caused by symptoms in each domain. Most items in the questionnaire use a 4-point scoring system. The score obtained for each domain ranges from 0 to 10. The sum of the subscores in the four domains gives the APFQ-H global score. The higher the score, the more severe the pelvic floor symptoms.

  2. Global Quality of Life

    Time frame: Through study completion, an average of 3 years

    Assessing with questionnaire: Hungarian WHOQOL-BREF. The WHOQOL-BREF is a self-administered questionnaire that contains 26 questions about an individual's health and well-being over the previous two weeks. Answers to the questions are given on a Likert scale of 1-5. The WHOQOL-BREF covers four domains (physical health, psychological, social relationships, environment). Scores in each of the 4 domains are converted into a scale ranging from 0 to 100. A score of 0 represents the worst possible health status, while a score of 100 represents the best possible health status for that domain.

Study contacts

Contact information is provided by the study sponsor or research team.

Eszter Ambrus

CONTACT

[email protected]

Márta Hock, PhD

CONTACT

[email protected]

+36-30-7213156

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Official study title

Prevalence of Anal Incontinence and Its Impact on Quality of Life and Physical Activity Among Hungarian Women Who Have Given Birth, and the Hungarian Language Validation of the International Consultation on Incontinence Modular Questionnaire-Bowels (ICIQ-B)

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 21, 2024
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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