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)

NCT06423222 | Recruiting

• 1 other identifier: BM/5814-3/2024
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Incontinence

Keywords

Anal Incontinence; Quality of Life; Physical Activity; Questionnaire

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Through study completion, an average of 3 years

Secondary Outcomes (2)

• Additional pelvic floor symptoms

  Through study completion, an average of 3 years

• Global Quality of Life

  Through study completion, an average of 3 years

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

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

Pécs, Baranya, H-7621, Hungary

RECRUITING

MeSH Terms

Conditions

Encopresis; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Márta Hock, PhD

  University of Pécs Faculty of Health Sciences

  STUDY DIRECTOR

• Eszter Ambrus

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Márta Hock, PhD

CONTACT

+36-30-7213156; hock.marta@etk.pte.hu

Eszter Ambrus

CONTACT

eszterkaja@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 21, 2024
• Study Start: April 22, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)