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Recruiting NCT06423222

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)

Observational Anal Incontinence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Anal Incontinence. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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)

Overview

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.

Primary outcome measures

  • Anal Incontinence Impact on Quality of Life [Time frame: Through study completion, an average of 3 years]
  • Anal Incontinence Impact on 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) [Time frame: Through study completion, an average of 3 years]
Secondary outcome measures (2)
  • Additional pelvic floor symptoms [Time frame: Through study completion, an average of 3 years]
  • Global Quality of Life [Time frame: Through study completion, an average of 3 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

Hungary · 1 center
  • Doctoral School of Health Sciences, Faculty of Health Sciences, University of Pécs — Pécs

Identifiers

NCT: NCT06423222 · BM/5814-3/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗