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

Diabetes Clinical Trial

— EFUI  

Official title:

Urinary Incontinence and Endocrine Factors.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04279184
• Other study ID #: SJ-493
• Status: Recruiting
• Start date: January 2016
• Est. completion date: February 2021

Study information

• Verified date: November 2020
• Source: Nykøbing Falster County Hospital
• Contact: Ea Løwenstein
• Phone: +4521930326
• Email: eapl[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: February 2021
• Est. primary completion date: February 2020
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Enuresis
• Thyroid Diseases
• Urinary Incontinence

Locations

Country	Name	City	State
Denmark	Randi Jepsen	Nykøbing Falster	Danmark

Sponsors (4)

Lead Sponsor	Collaborator
Nykøbing Falster County Hospital	Region Zealand, University of Southern Denmark, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of urinary incontinence	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.	4 years
Primary	Psychometric validation of ICIQ-UI SF (questionnaire used to assess urinary incontinence)	We investigated the predictive validity, internal consistency, patient-interview agreement, construct validity, test-retest reliability, and sensitivity to change for the ICIQ-UI SF.	2 years
Secondary	Association between urinary incontinence and diabetes	Assess by self-administered questionnaire and register data. Cross-sectional, measure once. The inclusion of participants are over a period of four years.	4 years
Secondary	Participants demographics	Assess by self-administered questionnaire and register data. Cross-sectional, measure once. The inclusion of participants are over a period of four years.	4 years
Secondary	Objective characterization of urinary incontinence in women with and without diabetes	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.	2 years