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Clinical Trials/NCT04279184
NCT04279184
Unknown
Not Applicable

Urinary Incontinence and Endocrine Factors.

Nykøbing Falster County Hospital1 site in 1 country6,000 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Incontinence
Sponsor
Nykøbing Falster County Hospital
Enrollment
6000
Locations
1
Primary Endpoint
Prevalence of urinary incontinence
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
February 2021
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Nykøbing Falster County Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Prevalence of urinary incontinence

Time Frame: 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)

Time Frame: 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 Outcomes

  • Participants demographics(4 years)
  • Association between urinary incontinence and diabetes(4 years)
  • Objective characterization of urinary incontinence in women with and without diabetes(2 years)

Study Sites (1)

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