NCT06627400

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
635

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

June 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2024

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

September 30, 2024

Last Update Submit

October 2, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • depression

    Yesavage Geriatric Depression Scale-short form;Scores above 4 were considered depression

    Baseline

  • frailty

    Fried fraility index; Scores above 2 were considered frail

    Baseline

  • insomnia

    The patient was asked if they had experienced complaints of insomnia in the last 1 months. if answer is yess, conisdered insomnia

    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

    Baseline

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • The patients with comprehensive geriatric assessment data

You may not qualify if:

  • dementia,
  • those who experienced cerebrovascular occlusion with resulting neuromuscular paralysis
  • active infections,
  • schizoaffective disorder,
  • epilepsy
  • neuromuscular disorders
  • those who were wheelchair or bed-bound,
  • advanced chronic obstructive pulmonary disease (COPD)
  • advanced chronic heart failure (CHF)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kastamonu University

Kastamonu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence, StressUrinary Incontinence, UrgeDepressive DisorderSleep Initiation and Maintenance DisordersFrailty

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMood DisordersMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPathologic Processes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 30, 2024

First Posted

October 4, 2024

Study Start

June 1, 2024

Primary Completion

August 30, 2024

Study Completion

September 10, 2024

Last Updated

October 4, 2024

Record last verified: 2024-10

Locations