Urinary Incontinence,StressNCT06627400
Association of Urinary Incontinence With Depression, Insomnia, Frailty and Falls in Older Adults
An observational study of Urinary Incontinence,Stress and Urinary Incontinence, Urge, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to provide a holistic analysis of the geriatric syndromes associated with urinary incontinence, which can result in significant adverse outcomes in the elderly, and to explore the gender-specific relationships within these associations. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Urinary Incontinence,Stress, Urinary Incontinence, Urge, Depressive Disorder
- How many people
- 635 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 10 Sep 2024
- How long will I take part?
- 9 Months
- 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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study was conducted using the electronic records of patients aged 60 and over who presented to the outpatient geriatric clinic from January 2024 to July 2024. The patients with comprehensive geriatric assessment data were included in the study. Patients with dementia, those who experienced cerebrovascular occlusion with resulting neuromuscular paralysis, individuals with active infections, schizoaffective disorder, epilepsy or other neuromuscular disorders, as well as those who were wheelchair or bed-bound, and patients with advanced chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) were excluded from the study.
Who may be able to join
- The patients with comprehensive geriatric assessment data
Who cannot join
- dementia,
- those who experienced cerebrovascular occlusion with resulting neuromuscular paralysis
- active infections,
- schizoaffective disorder,
- epilepsy
- neuromuscular disorders
Show all 9Show fewer
- those who were wheelchair or bed-bound,
- advanced chronic obstructive pulmonary disease (COPD)
- advanced chronic heart failure (CHF)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Urinary Incontinence With Depression, Insomnia, Frailty and Falls in Older Adults: a Cross-sectional Comprehensive Geriatric Assessment
The aim of our study is to provide a holistic analysis of the geriatric syndromes associated with urinary incontinence, which can result in significant adverse outcomes in the elderly, and to explore the gender-specific relationships within these associations. The study revealed that urinary incontinence is highly prevalent among the older adults, particularly in women, and is associated strongly with depression, insomnia, frailty, and falls. Moreover, while older women with urinary incontinence exhibited more depressive symptoms than men, urinary incontinence was associated with similar frequencies of insomnia in both sexes. Considering the negative outcomes of depression, insomnia, frailty, and falls in older adults, as well as a decline in functionality, cognitive impairment, and prolonged hospitalizations and even mortality they cause, it becomes evident that urinary incontinence must be routinely assessed and treated by clinicians.
- Conditions
- Urinary Incontinence,Stress, Urinary Incontinence, Urge, Depressive Disorder, Insomnia, Frailty, Fall
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Urge, Depressive Disorder, Sleep Initiation and Maintenance Disorders, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
depression
Yesavage Geriatric Depression Scale-short form;Scores above 4 were considered depression
Measured: Baseline
frailty
Fried fraility index; Scores above 2 were considered frail
Measured: Baseline
insomnia
The patient was asked if they had experienced complaints of insomnia in the last 1 months. if answer is yess, conisdered insomnia
Measured: Baseline
fall history
The patient was asked if they had a history of falls in the past year.if answer is yess, conisdered fall history
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start1 Jun 2024
- Primary completion30 Aug 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence,StressStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 635 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sultan Keskin Demircan, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627400
- Sponsor's protocol ID
- Medical Doctor
- Status last verified
- Oct 2024
- First submitted
- 30 Sep 2024
- Last updated
- 4 Oct 2024
- 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 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Urinary Incontinence With Depression, Insomnia, Frailty and Falls in Older Adults: a Cross-sectional Comprehensive Geriatric Assessment
- ClinicalTrials.gov ID
- NCT06627400
- Acronym / sponsor ID
- Medical Doctor
- Conditions
- Urinary Incontinence,Stress, Urinary Incontinence, Urge, Depressive Disorder, Insomnia, Frailty, Fall
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 635 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 4 Oct 2024 (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.
The aim of our study is to provide a holistic analysis of the geriatric syndromes associated with urinary incontinence, which can result in significant adverse outcomes in the elderly, and to explore the gender-specific relationships within these associations. The study revealed that urinary incontinence is highly prevalent among the older adults, particularly in women, and is associated strongly with depression, insomnia, frailty, and falls. Moreover, while older women with urinary incontinence exhibited more depressive symptoms than men, urinary incontinence was associated with similar frequencies of insomnia in both sexes. Considering the negative outcomes of depression, insomnia, frailty, and falls in older adults, as well as a decline in functionality, cognitive impairment, and prolonged hospitalizations and even mortality they cause, it becomes evident that urinary incontinence must be routinely assessed and treated by clinicians.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 9 Months
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study was conducted using the electronic records of patients aged 60 and over who presented to the outpatient geriatric clinic from January 2024 to July 2024. The patients with comprehensive geriatric assessment data were included in the study. Patients with dementia, those who experienced cerebrovascular occlusion with resulting neuromuscular paralysis, individuals with active infections, schizoaffective disorder, epilepsy or other neuromuscular disorders, as well as those who were wheelchair or bed-bound, and patients with advanced chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) were excluded from the study.
Key inclusion criteria (1 listed)
- The patients with comprehensive geriatric assessment data
Key exclusion criteria (9 listed)
- dementia,
- those who experienced cerebrovascular occlusion with resulting neuromuscular paralysis
- active infections,
- schizoaffective disorder,
- epilepsy
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
depression
Time frame: Baseline
Yesavage Geriatric Depression Scale-short form;Scores above 4 were considered depression
frailty
Time frame: Baseline
Fried fraility index; Scores above 2 were considered frail
insomnia
Time frame: Baseline
The patient was asked if they had experienced complaints of insomnia in the last 1 months. if answer is yess, conisdered insomnia
fall history
Time frame: Baseline
The patient was asked if they had a history of falls in the past year.if answer is yess, conisdered fall history
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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,Stress and Urinary Incontinence, Urge, run by Kastamonu University at 1 site in Turkey (Türkiye).
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 1 inclusion and 9 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: finished, as of the sponsor's last update on 4 Oct 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depression (time frame: Baseline). The study lists 4 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 4 Oct 2024.