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

• Conditions: Urinary Incontinence; Diabetes; Thyroid Diseases

• Registration Number: NCT04279184
• Lead Sponsor: Nykøbing Falster County Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2020-01-16
• Primary Completion: 2020-02
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-21
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-26
• Last Update Posted: 2020-12-01
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 6000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Randi Jepsen; 🇩🇰 Nykøbing Falster, Danmark, Denmark