An observational study in Anal Incontinence, sponsored by University of Pecs. Recruiting at 1 site in Hungary. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by University of Pecs · Observational
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.
312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.
This study's planned enrollment of 250 is above the median of 100 across 79 observational studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →University of Pecs is the lead sponsor of 100 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
We plan to include subjects who are female, over the age of 18, under the age of 50 and who have given birth at least once before.
Exclusion Criteria:
Anal Incontinence Impact on Quality of Life
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.
Time frame: Through study completion, an average of 3 years
Anal Incontinence Impact on Physical Activity
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.
Time frame: Through study completion, an average of 3 years
Adaptation, validity and reliability of the Hungarian version of the International Consultation on Incontinence Modular Questionnaire-Bowels (ICIQ-B)
Evaluating with statistical analysis the content/face validity, internal consistency, construct validity, test-retest reproducibility, discriminant validity and convergent validity.
Time frame: Through study completion, an average of 3 years
Additional pelvic floor symptoms
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.
Time frame: Through study completion, an average of 3 years
Global Quality of Life
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.
Time frame: Through study completion, an average of 3 years
Plan to share: No
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