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

Urinary Incontinence and Endocrine Factors.

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes; Thyroid Diseases; Urinary Incontinence

• Study Type: Observational
• Enrollment (Anticipated): 6000

Contacts and Locations

Study Locations

• Denmark
  • Danmark
    • Nykøbing Falster, Danmark, Denmark, 4800
      • Recruiting
      • Randi Jepsen
      • Contact: Randi Jepsen; Phone Number: +4556516860; Email: rjep@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The population of Lolland and Guldborgsund municipalities in Denmark.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Nykøbing Falster County Hospital
• Collaborators: Zealand University Hospital; University of Southern Denmark; Region Zealand
• Investigators: Principal Investigator: Helga Gimbel, Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): February 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 26, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Endocrine System Diseases; Urination Disorders; Elimination Disorders; Urinary Incontinence; Thyroid Diseases; Enuresis
• Other Study ID Numbers: SJ-493

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No