AzTrials
AzTrials

Anal IncontinenceNCT06423222

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)

An observational study of Anal Incontinence, run by University of Pecs at 1 site in Hungary.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Anal Incontinence
How many people
250 participants
Where
1 siteHungary
Study dates
22 Apr 2024to Jul 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • 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.

Who may be able to join

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

Who cannot join

  • Menopause
  • Irritable Bowel Syndrome (IBS)
  • Chron's disease
  • Ulcerative colitis
  • Developmental abnormalities at the level of the pelvic organs
  • Uninvestigated pelvic pain
Show all 11Show fewer
  • Malignant pelvic tumor
  • Radiotherapy involving the pelvis
  • Neurological diseases with muscle weakness
  • Parkinson's disease
  • Intellectual disability

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Márta Hock, PhD contact

+36-30-7213156

hock.marta@etk.pte.hu

Eszter Ambrus contact

eszterkaja@gmail.com

Hungary1 site, 1 recruiting

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

    Pécs, Baranya, H-7621

    Márta Hock, Phd, +36-30-7213156, hock.marta@etk.pte.hu

    Recruiting

Other trials in Hungary

About this study

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)

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.

Keywords
Anal Incontinence, Quality of Life, Physical Activity, Questionnaire
Medical subject headings
Encopresis, Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through study completion, an average of 3 years

  2. 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.

    Measured: Through study completion, an average of 3 years

  3. 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.

    Measured: Through study completion, an average of 3 years

Secondary outcomes (2)

  1. 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.

    Measured: Through study completion, an average of 3 years

  2. 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.

    Measured: Through study completion, an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2024
  2. Study start22 Apr 2024
  3. Primary completionJan 2026 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06423222
Sponsor's protocol ID
BM/5814-3/2024
Status last verified
May 2024
First submitted
5 May 2024
Last updated
21 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Anal Incontinence, run by University of Pecs at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Márta Hock, PhD (+36-30-7213156, hock.marta@etk.pte.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anal Incontinence Impact on Quality of Life (time frame: Through study completion, an average of 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06423222.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in