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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05277467
Other study ID # 22
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date December 30, 2021

Study information

Verified date March 2022
Source Ankara Medipol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The objective was to evaluate the severity of urinary incontinence (UI) in elderly patients and its impact on the burden of care in their family caregivers. The study is a descriptive, cross-sectional and relationship-seeking type of research. It was conducted prospectively with 80 elderly(≥65 years of age) patients with UI and their family caregivers who applied to the urology clinic between June and December 2021. The data was collected using the "Socio-Demographic Characteristics Data Collection Form". UI was assessed by "International Consultation on Incontinence Questionnaire Short Form(ICIQ-UI-SF)" and caregiver burden by means of Zarit Burden Scale(ZBI) form.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - The family member who did not volunteer to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
no intervention

Locations

Country Name City State
Turkey Ankara Medipol University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View Citation

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/ — View Citation

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. — View Citation

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

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 — View Citation

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 J — View Citation

Yenisehir S, Çitak 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
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