NCT05277467

Brief Summary

The purpose of this study is to evaluate the severity of urinary incontinence (UI) in elderly patients and its impact on the burden of care in their family caregivers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

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, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

February 1, 2022

Last Update Submit

March 3, 2022

Conditions

Keywords

urinary incontinenceelderly patientfamily membercaregivercaregiver burden

Outcome Measures

Primary Outcomes (2)

  • International Consultation on Incontinence Questionnaire Short Form

    It is a reliable and useful form developed to examine the effect of UI on quality of life. There are questions on the scale that include evaluating the effect of UI on frequency, amount, causes and burden of care. The scale is of likert type and consists of four dimensions. The first dimension includes the frequency of the UI, the second dimension the amount of the UI, the third dimension the impact of the UI on daily life, and the fourth dimension the situations that cause the UI. The maximum score that can be obtained from the scale is 21, and 8 points and above define the UI that causes discomfort.

    This form was applied to the patients immediately after the patient examination at the urology clinic.

  • Zarit Burden Interview

    The caregiving burden scale was used to evaluate the difficulty of providing care experienced by caregivers. 0-20 points from the scale indicate "never a burden of care'', 21-40 points indicate "burden of care rarely'', 41-60 points indicate "burden of care quite frequently'' and 61-88 points indicate "burden of care nearly always''.

    This form was applied to the patients immediately after the patient examination at the urology clinic.

Interventions

no intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study was conducted prospectively with 80 elderly (≥65 years of age) patients with UI and their family caregivers who applied to the urology clinic of a state hospital between June and December 2021 and who have agreed to the study.

You may qualify if:

  • The primary caregiver family member (mother, father, spouse, sibling, child), appropriate cognitive and mental health to respond to the applied forms, constant patient care
  • The patient's being 65 years and older and diagnosed with urinary incontinence.

You may not qualify if:

  • The family member who did not volunteer to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Medipol University

Ankara, Turkey (Türkiye)

Location

Related Publications (7)

  • Eifert EK, Adams R, Dudley W, Perko M. Family caregiver identity: A literature review. American Journal of Health Education. 2015;46(6):357-67.

    BACKGROUND
  • D'Ancona C, Haylen B, Oelke M, Abranches-Monteiro L, Arnold E, Goldman H, Hamid R, Homma Y, Marcelissen T, Rademakers K, Schizas A, Singla A, Soto I, Tse V, de Wachter S, Herschorn S; Standardisation Steering Committee ICS and the ICS Working Group on Terminology for Male Lower Urinary Tract & Pelvic Floor Symptoms and Dysfunction. The International Continence Society (ICS) report on the terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction. Neurourol Urodyn. 2019 Feb;38(2):433-477. doi: 10.1002/nau.23897. Epub 2019 Jan 25.

    PMID: 30681183BACKGROUND
  • Talley KMC, Davis NJ, Peden-McAlpine C, Martin CL, Weinfurter EV, Wyman JF. Navigating through incontinence: A qualitative systematic review and meta-aggregation of the experiences of family caregivers. Int J Nurs Stud. 2021 Nov;123:104062. doi: 10.1016/j.ijnurstu.2021.104062. Epub 2021 Aug 13.

  • Yang E, Lisha NE, Walter L, Obedin-Maliver J, Huang AJ. Urinary Incontinence in a National Cohort of Older Women: Implications for Caregiving and Care Dependence. J Womens Health (Larchmt). 2018 Sep;27(9):1097-1103. doi: 10.1089/jwh.2017.6891. Epub 2018 Jun 14.

  • Yenisehir S, Citak Karakaya I, Karakaya MG. Knowledge and practice of nursing home caregivers about urinary incontinence. Eur Geriatr Med. 2019 Feb;10(1):99-105. doi: 10.1007/s41999-018-0129-0. Epub 2018 Nov 13.

  • Di Rosa M, Lamura G. The impact of incontinence management on informal caregivers' quality of life. Aging Clin Exp Res. 2016 Feb;28(1):89-97. doi: 10.1007/s40520-015-0367-7. Epub 2015 May 10.

  • Davis NJ, Parker VG, Lanham J, Love CR, Christy MR, Poetzschke E, Wyman JF. Burdens and Educational Needs of Informal Caregivers of Older Adults With Urinary Incontinence: An Internet-Based Study. Rehabil Nurs. 2021 May-Jun 01;46(3):172-178. doi: 10.1097/rnj.0000000000000317.

MeSH Terms

Conditions

Caregiver BurdenUrinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nilay BEKTAS AKPINAR, PhD

    Ankara Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 1, 2022

First Posted

March 14, 2022

Study Start

June 1, 2021

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

March 14, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations