NCT06827561

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2024

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
Last Updated

February 14, 2025

Status Verified

September 1, 2024

Enrollment Period

14 days

First QC Date

January 31, 2025

Last Update Submit

February 9, 2025

Conditions

Keywords

PresbyphagiaUrinary IncontinenceQuality of Life

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    1 day

Study Arms (2)

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.

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy elderly people living in a nursing home

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haci Ahmet Şençopur Huzurevi Yaşli Bakim Ve Rehabilitasyon Merkezi

Uluborlu, Isparta, 32000, Turkey (Türkiye)

Location

Uluborlu Gardenia Care Center

Uluborlu, Isparta, 32000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 39032316BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 14, 2025

Study Start

November 8, 2024

Primary Completion

November 22, 2024

Study Completion

December 15, 2024

Last Updated

February 14, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Sharing the personal data of elderly residents of the institution constitutes a crime for the Republic of Turkey.

Locations