Skip to main content
Clinical Trials/NCT06423222
NCT06423222
Recruiting
Not Applicable

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)

University of Pecs1 site in 1 country250 target enrollmentApril 22, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anal Incontinence
Sponsor
University of Pecs
Enrollment
250
Locations
1
Primary Endpoint
Adaptation, validity and reliability of the Hungarian version of the International Consultation on Incontinence Modular Questionnaire-Bowels (ICIQ-B)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 22, 2024
End Date
July 2027
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • Global Quality of Life(Through study completion, an average of 3 years)
  • Additional pelvic floor symptoms(Through study completion, an average of 3 years)

Study Sites (1)

Loading locations...

Similar Trials