- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05277467
Elderly Urinary Incontinence Caregiver Burden
Urinary Incontinence in Elderly Patients and Its Impact on Caregiver Burden: An Overlooked and Underestimated Topic
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey
- Ankara Medipol University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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International Consultation on Incontinence Questionnaire Short Form
Time Frame: This form was applied to the patients immediately after the patient examination at the urology clinic.
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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.
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This form was applied to the patients immediately after the patient examination at the urology clinic.
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Zarit Burden Interview
Time Frame: This form was applied to the patients immediately after the patient examination at the urology clinic.
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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''.
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This form was applied to the patients immediately after the patient examination at the urology clinic.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nilay BEKTAS AKPINAR, PhD, Ankara Medipol University
Publications and helpful links
General Publications
- 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.
- 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.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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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