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EFUI: Urinary Incontinence and Endocrine Factors. A Part of Lolland-Falster Health Study (LOFUS).

Sponsor
Nykøbing Falster County Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04279184
Collaborator
Region Zealand (Other), Zealand University Hospital (Other), University of Southern Denmark (Other)
6,000
Enrollment
1
Location
61
Anticipated Duration (Months)
98.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Previous studies have shown an increase in the prevalence of urgency and urgency incontinence in women with diabetes. Regarding the condition urinary stress incontinence, the literature is diverted.

The purpose of the PhD project is investigate the prevalence of urinary incontinence and the association to diabetes and thyroid disease in a mainly rual population in Lolland and Falster. Further to investigate if there is any difference in the bladder function in incontinent women with and without diabetes.

Psychometric validation of the questionnaire used to assess urinary incontinence was also performed.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    6000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Urinary Incontinence and Endocrine Factors.
    Actual Study Start Date :
    Jan 1, 2016
    Actual Primary Completion Date :
    Feb 1, 2020
    Anticipated Study Completion Date :
    Feb 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of urinary incontinence [4 years]

      Assess by self-administered questionnaire and register data. Cross-sectional, measure once. The questionnaire International Consultation on Incontinence Questionnaire - Urinary Incontinence Short form (ICIQ-UI SF) was used to assess urinary incontinence (UI). It consist of six questions, and the score of three of the questions (assessing frequency of UI, volume of leak and bother) sums up to a total score. It ranges between 0-21 where 0 is no incontinence and a higher score indicates more severe symptoms of UI. The inclusion of participants are over a period of four years.

    2. Psychometric validation of ICIQ-UI SF (questionnaire used to assess urinary incontinence) [2 years]

      We investigated the predictive validity, internal consistency, patient-interview agreement, construct validity, test-retest reliability, and sensitivity to change for the ICIQ-UI SF.

    Secondary Outcome Measures

    1. Association between urinary incontinence and diabetes [4 years]

      Assess by self-administered questionnaire and register data. Cross-sectional, measure once. The inclusion of participants are over a period of four years.

    2. Participants demographics [4 years]

      Assess by self-administered questionnaire and register data. Cross-sectional, measure once. The inclusion of participants are over a period of four years.

    3. Objective characterization of urinary incontinence in women with and without diabetes [2 years]

      Assess by urodynamics studies. Description of type of urinary incontinence, first sensation (ml), normal desire (ml), urgency (ml), max capacity (ml) and PVR (ml). Measured once for each participants. Data collected over a period of two years.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:

    • woman

    • 18 years or above

    • participating i The Lolland-Falster Health Study (NCT02482896)

    Exclusion Criteria:

    • male

    • below 18 years

    • non-participating i The Lolland-Falster Health Study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Randi Jepsen Nykøbing Falster Danmark Denmark 4800

    Sponsors and Collaborators

    • Nykøbing Falster County Hospital
    • Region Zealand
    • Zealand University Hospital
    • University of Southern Denmark

    Investigators

    • Principal Investigator: Helga Gimbel, Zealand University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nykøbing Falster County Hospital
    ClinicalTrials.gov Identifier:
    NCT04279184
    Other Study ID Numbers:
    • SJ-493
    First Posted:
    Feb 21, 2020
    Last Update Posted:
    Dec 1, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urinary Incontinence
    Enuresis
    Thyroid Diseases

    Study Results

    No Results Posted as of Dec 1, 2020