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

NCT04279184 | Unknown

• 1 other identifier: SJ-493
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Diabetes; Thyroid Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Association between urinary incontinence and diabetes

  4 years

• Participants demographics

  4 years

• Objective characterization of urinary incontinence in women with and without diabetes

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population of Lolland and Guldborgsund municipalities in Denmark.

You may qualify if:

• woman
• years or above
• participating i The Lolland-Falster Health Study (NCT02482896)

You may not qualify if:

• male
• below 18 years
• non-participating i The Lolland-Falster Health Study

Sponsors & Collaborators

• Nykøbing Falster County Hospital: lead
• Region Zealand: collaborator
• Zealand University Hospital: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Randi Jepsen

Nykøbing Falster, Danmark, 4800, Denmark

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence; Diabetes Mellitus; Thyroid Diseases

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Helga Gimbel

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ea Løwenstein

CONTACT

+4521930326; eapl@regionsjaelland.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: February 21, 2020
• Study Start: January 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2021
• Last Updated: December 1, 2020

Record last verified: 2020-11

Locations

DK (1)