- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04279184
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
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ea Løwenstein
- Phone Number: +4521930326
- Email: eapl@regionsjaelland.dk
Study Locations
-
-
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
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between urinary incontinence and diabetes
Time Frame: 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.
|
4 years
|
Participants demographics
Time Frame: 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.
|
4 years
|
Objective characterization of urinary incontinence in women with and without diabetes
Time Frame: 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.
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Helga Gimbel, Zealand University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SJ-493
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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