## Protocol Section
### Identification Module
**NCT ID:** NCT06423222

**Brief Title:** 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)

**Official 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)

#### Organization Study ID Info
**ID:** BM/5814-3/2024
#### Organization
**Class:** OTHER
**Full Name:** University of Pecs
### Status Module
#### Completion Date
**Date:** 2027-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-22

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-05
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Pecs

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Anal Incontinence

**Keywords:**

- Anal Incontinence

- Quality of Life

- Physical Activity

- Questionnaire

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 250

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Anal Incontinence Impact on Quality of Life

**Time Frame:** Through study completion, an average of 3 years

**Description:** 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.

**Measure:** Anal Incontinence Impact on Physical Activity

**Time Frame:** Through study completion, an average of 3 years

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

**Measure:** 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

#### Secondary Outcomes

**Description:** 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.

**Measure:** Additional pelvic floor symptoms

**Time Frame:** Through study completion, an average of 3 years

**Description:** 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.

**Measure:** Global Quality of Life

**Time Frame:** Through study completion, an average of 3 years

### Eligibility Module

**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
* Intellectual disability

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hock.marta@etk.pte.hu

**Name:** Márta Hock, PhD

**Phone:** +36-30-7213156

**Role:** CONTACT

**Contact 2:**

**Email:** eszterkaja@gmail.com

**Name:** Eszter Ambrus

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Pécs

**Contacts:**

***Contact 1:***

- **Email:** hock.marta@etk.pte.hu

- **Name:** Márta Hock, Phd

- **Phone:** +36-30-7213156

- **Role:** CONTACT

**Country:** Hungary

**Facility:** Doctoral School of Health Sciences, Faculty of Health Sciences, University of Pécs

**State:** Baranya

**Status:** RECRUITING

**Zip:** H-7621

#### Overall Officials

**Official 1:**

**Affiliation:** University of Pécs Faculty of Health Sciences

**Name:** Márta Hock, PhD

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Doctoral School of Health Sciences, Faculty of Health Sciences, University of Pécs, Pécs, Hungary

**Name:** Eszter Ambrus

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012002

- Term: Rectal Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M8381

- Name: Fecal Incontinence

- Relevance: HIGH

- As Found: Anal Incontinence

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: HIGH

- As Found: Quality of Life

### Condition Browse Module - Meshes

- ID: D000005242

- Term: Fecal Incontinence

### Misc Info Module

- Version Holder: 2024-05-31
