PresbyphagiaPresbyphagiaNCT06827561
The Effect of Presbyphagia on Urinary Incontinence and Quality of Life in Healthy Elderly People in Nursing Homes
An observational study of Presbyphagia and Incontinence, Urinary, run by Isparta University of Applied Sciences at 2 sites in Turkey (Türkiye).
Trial summary
Urinary incontinence in the elderly and health-related quality of life due to urinary incontinence is a common problem in nursing homes. Another problem that occurs in elderly individuals is swallowing disorder. Swallowing disorders that occur with aging are called presbyphagia. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyphagia, Incontinence, Urinary, Quality of Life
- How many people
- 73 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 8 Nov 2024to 15 Dec 2024
- How long will I take part?
- 1 Day
- 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 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Healthy elderly people living in a nursing home
Who may be able to join
- Individuals who have been living in the nursing home for at least 1 year and volunteer to participate in the study
- a mini metal test score of 24 and above
Who cannot join
- Those who cannot provide information on urinary function and quality of life,
- Those with a history of disease and surgery with mechanisms directly related to swallowing and urinary incontinence,
- Those with a mini mental test score of 23 or less were excluded
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Haci Ahmet Şençopur Huzurevi Yaşli Bakim Ve Rehabilitasyon Merkezi
Uluborlu, Isparta, 32000
Uluborlu Gardenia Care Center
Uluborlu, Isparta, 32000
About this study
Urinary incontinence in the elderly and health-related quality of life due to urinary incontinence is a common problem in nursing homes. Another problem that occurs in elderly individuals is swallowing disorder. Swallowing disorders that occur with aging are called presbyphagia. Additional health problems such as impaired fluid intake balance, fetal incontinence and sarcopenia may occur after presbyphagia. However, the effect of presbyphagia on urinary incontinence is not known. In this study, we aimed to determine the effect of presbyphagia on urinary incontinence and quality of life in healthy elderly individuals living in a nursing home.
- Conditions
- Presbyphagia, Incontinence, Urinary, Quality of Life
- Keywords
- Presbyphagia, Urinary Incontinence, Quality of Life
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Presbyphagia Group | This is a group of elderly people with swallowing disorders. Urinary incontinence and quality of life will be evaluated diagnostically. | |
| Non-Presbyphagia Group | This group is an elderly group in which swallowing disorder is not detected. Urinary incontinence and quality of life will be evaluated diagnostically. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the presence of urinary incontinence
Determination of urinary incontinence in the elderly with swallowing problems using the International Consultation on Incontinence Questionnaire Short (ICIQ) scale.
Measured: 1 day
Determining the presence ofquality of life
Determination of health-related quality of life related to urinary incontinence in elderly people with swallowing problems using King's Health Questionnaire (KHQ) scale
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start8 Nov 2024
- Primary completion22 Nov 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PresbyphagiaStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Isparta University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827561
- Sponsor's protocol ID
- postdr1
- Acronym
- Presbyphagia
- Status last verified
- Sep 2024
- First submitted
- 31 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing the personal data of elderly residents of the institution constitutes a crime for the Republic of Turkey.
Publications
Kakehi S, Wakabayashi H, Isono E, Takemura R, Sato Y, Otsuka Y, Nagai T, Nishioka S, Momosaki R. Association between sarcopenia and urinary dysfunction in patients with dysphagia. Arch Gerontol Geriatr. 2024 Dec;127:105577. doi: 10.1016/j.archger.2024.105577. Epub 2024 Jul 19.
PubMed 39032316Yildiz Z. The association of presbyphagia with urinary incontinence and Incontinence-related quality of life in nursing home residents: A cross-sectional study. PLoS One. 2026 Jun 4;21(6):e0350933. doi: 10.1371/journal.pone.0350933. eCollection 2026.
PubMed 42241411
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Presbyphagia on Urinary Incontinence and Quality of Life in Healthy Elderly People in Nursing Homes
- ClinicalTrials.gov ID
- NCT06827561
- Acronym / sponsor ID
- Presbyphagia / postdr1
- Conditions
- Presbyphagia, Incontinence, Urinary, Quality of Life
- Keywords
- Presbyphagia, Urinary Incontinence, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Isparta University of Applied SciencesUniversity, hospital or other
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 14 Feb 2025 (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.
Urinary incontinence in the elderly and health-related quality of life due to urinary incontinence is a common problem in nursing homes. Another problem that occurs in elderly individuals is swallowing disorder. Swallowing disorders that occur with aging are called presbyphagia. Additional health problems such as impaired fluid intake balance, fetal incontinence and sarcopenia may occur after presbyphagia. However, the effect of presbyphagia on urinary incontinence is not known. In this study, we aimed to determine the effect of presbyphagia on urinary incontinence and quality of life in healthy elderly individuals living in a nursing home.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Presbyphagia Group | – | –This is a group of elderly people with swallowing disorders. Urinary incontinence and quality of life will be evaluated diagnostically. |
| Non-Presbyphagia Group | – | –This group is an elderly group in which swallowing disorder is not detected. Urinary incontinence and quality of life will be evaluated diagnostically. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Healthy elderly people living in a nursing home
Key inclusion criteria (2 listed)
- Individuals who have been living in the nursing home for at least 1 year and volunteer to participate in the study
- a mini metal test score of 24 and above
Key exclusion criteria (3 listed)
- Those who cannot provide information on urinary function and quality of life,
- Those with a history of disease and surgery with mechanisms directly related to swallowing and urinary incontinence,
- Those with a mini mental test score of 23 or less were excluded
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
Determining the presence of urinary incontinence
Time frame: 1 day
Determination of urinary incontinence in the elderly with swallowing problems using the International Consultation on Incontinence Questionnaire Short (ICIQ) scale.
Determining the presence ofquality of life
Time frame: 1 day
Determination of health-related quality of life related to urinary incontinence in elderly people with swallowing problems using King's Health Questionnaire (KHQ) scale
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 14 Feb 2025.
- Background: PubMed 39032316Kakehi S, Wakabayashi H, Isono E, Takemura R, Sato Y, Otsuka Y, Nagai T, Nishioka S, Momosaki R. Association between sarcopenia and urinary dysfunction in patients with dysphagia. Arch Gerontol Geriatr. 2024 Dec;127:105577. doi: 10.1016/j.archger.2024.105577. Epub 2024 Jul 19.
- Derived from this study: PubMed 42241411Yildiz Z. The association of presbyphagia with urinary incontinence and Incontinence-related quality of life in nursing home residents: A cross-sectional study. PLoS One. 2026 Jun 4;21(6):e0350933. doi: 10.1371/journal.pone.0350933. eCollection 2026.
- Individual participant dataSharing planned: No. Sharing the personal data of elderly residents of the institution constitutes a crime for the Republic of Turkey.
Related trials for Presbyphagia
Enrolling by invitationPhase 3
Effect of Biofeedback Tongue Strengthening Program on Tongue Pressure and Swallowing Performance
Presbyphagia, Abnormal Tongue Pressure
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Presbyphagia and Incontinence, Urinary, run by Isparta University of Applied Sciences at 2 sites 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 2 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: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Determining the presence of urinary incontinence (time frame: 1 day). 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?
On the ClinicalTrials.gov record for NCT06827561, which also lists 2 linked publications.
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 14 Feb 2025.