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

Urinary Incontinence and Endocrine Factors.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04279184

Acronym

EFUI

Enrollment

6000

Registered

2020-02-21

Start date

2016-01-31

Completion date

2021-02-28

Last updated

2020-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Thyroid Diseases, Urinary Incontinence

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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

Measure	Time frame	Description
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.
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.
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.

Countries

Denmark

Contacts

Primary ContactEa Løwenstein

eapl@regionsjaelland.dk+4521930326

Outcome results