Urinary IncontinenceEFUINCT04279184
Urinary Incontinence and Endocrine Factors. A Part of Lolland-Falster Health Study (LOFUS).
An observational study of Urinary Incontinence and Diabetes, run by Nykøbing Falster County Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Diabetes, Thyroid Diseases
- How many people
- 6,000 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: The population of Lolland and Guldborgsund municipalities in Denmark.
Who may be able to join
- woman
- 18 years or above
- participating i The Lolland-Falster Health Study (NCT02482896)
Who cannot join
- male
- below 18 years
- non-participating i The Lolland-Falster Health Study
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Randi Jepsen
Nykøbing Falster, Danmark, 4800
Randi Jepsen, +4556516860, rjep@regionsjaelland.dk
About this study
Official title: 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.
- Conditions
- Urinary Incontinence, Diabetes, Thyroid Diseases
- Medical subject headings
- Urinary Incontinence, Diabetes Mellitus, Thyroid Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study startJan 2016
- Primary completionFeb 2020
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nykøbing Falster County Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region Zealand, Zealand University Hospital, University of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Helga Gimbel, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279184
- Sponsor's protocol ID
- SJ-493
- Acronym
- EFUI
- Status last verified
- Nov 2020
- First submitted
- 16 Jan 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Incontinence and Endocrine Factors.
- ClinicalTrials.gov ID
- NCT04279184
- Acronym / sponsor ID
- EFUI / SJ-493
- Conditions
- Urinary Incontinence, Diabetes, Thyroid Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Nykøbing Falster County HospitalUniversity, hospital or other
- Collaborators
- Region Zealand, Zealand University Hospital, University of Southern Denmark
- Study start
- Jan 2016 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2021 (estimated)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The population of Lolland and Guldborgsund municipalities in Denmark.
Key inclusion criteria (3 listed)
- woman
- 18 years or above
- participating i The Lolland-Falster Health Study (NCT02482896)
Key exclusion criteria (3 listed)
- male
- below 18 years
- non-participating i The Lolland-Falster Health Study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Association between urinary incontinence and diabetes
Time frame: 4 years
Participants demographics
Time frame: 4 years
Objective characterization of urinary incontinence in women with and without diabetes
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helga Gimbel principal investigator
Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Diabetes, run by Nykøbing Falster County Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ea Løwenstein (+4521930326, eapl@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of urinary incontinence (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.