NCT05618184

Brief Summary

The aim of this study is to assess the prevalence of urinary incontinence among Hungarian women. In addition to that, we aim evaluate the health related quality of life among Hungarian women with urinary incontinence and to culturally adapt the following questionnaires for the Hungarian population: Incontinence Impact Questionnaire - Short Form (IIQ-7) and King's Health Questionnaire (KHQ).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 8, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2024

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

November 8, 2022

Last Update Submit

December 8, 2024

Conditions

Keywords

Quality of life

Outcome Measures

Primary Outcomes (3)

  • International Consultation of Incontinence Questionnaire - Short Form

    The International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF) will be used to gather information about the symptoms of urinary incontinence. It contains six questions. The total score can range from 0 to 21, with higher scores suggesting more severe symptoms.

    Baseline

  • King's Health Questionnaire

    The King's Health Questionnaire (KHQ) will be used to measure the impact of urinary incontinence on the subject's health related quality of life. It assesses quality of life in nine different domains of life. Each domain is scored separately ranging from 0 (best) to 100 (worst).

    Baseline

  • Incontinence Impact Questionnaire short form

    The Incontinence Impact Questionnaire short form (IIQ-7) will be also used to measure the impact of urinary incontinence on the subject's health related quality of life. It is comprised of seven questions. The total score ranges from 0 to 21, with higher scores indicating more severe symptoms and worse quality of life.

    Baseline

Secondary Outcomes (1)

  • Short-Form-36

    Baseline

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women aged 18 years or older who are able to read and write Hungarian.

You may qualify if:

  • Woman
  • Age 18 and above
  • Providing consent to participate
  • Ability to read and write Hungarian

You may not qualify if:

  • Respondents who are unable to complete the online survey due to illiteracy
  • Man

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pécs

Pécs, Baranya, 7621, Hungary

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Márta Hock, Habilitation

    University of Pecs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2022

First Posted

November 16, 2022

Study Start

May 8, 2024

Primary Completion

October 21, 2024

Study Completion

December 2, 2024

Last Updated

December 12, 2024

Record last verified: 2024-12

Locations