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Clinical Trials/NCT05892575
NCT05892575Not yet recruitingNot Applicable

The Effect of Urinary Incontinence Management Program in Obese Elderly on Quality of Life, 'Coping With Incontinence' and Loneliness

Ondokuz Mayıs University1 site in 1 country60 target enrollmentStarted: July 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Urogenital distress inventory

Study Overview

Brief Summary

The goal of this: It was planned in a single-blind randomized controlled pre-test-post-test experimental research design. The aim of this study is to determine the effect of urinary incontinence management program on quality of life, coping with incontinence and loneliness in obese elderly.

The main questions it aims to answer are:

Does the Urinary Incontinence Management Program prepared for the obese elderly affect the quality of life, coping with incontinence and loneliness levels of the elderly in the experimental and control groups? After the Urinary Incontinence Management Program prepared for the obese elderly, is there an increase in the incontinence quality of life of the obese elderly in the experimental group compared to the obese elderly in the control group? After the Urinary Incontinence Management Program prepared for the obese elderly, is there an increase in the level of coping with incontinence of the obese elderly in the experimental group compared to the obese elderly in the control group? After the Urinary Incontinence Management Program prepared for the obese elderly, is there a decrease in the loneliness levels of the obese elderly in the experimental group compared to the obese elderly in the control group? After the Urinary Incontinence Management Program prepared for the obese elderly, is there an increase in the incontinence quality of life, coping with incontinence and loneliness levels of the elderly in the experimental group after the intervention compared to the pre-intervention?

Detailed Description

Worldwide, there is a transition from a young population structure to an aging population structure, and life expectancy at birth is increasing. As the global growth of the elderly population will continue, we are moving towards an aging world.

According to the World Health Organization, it is estimated that the population aged 60 and over will reach 2 billion by 2050. With increasing age, changes occur in every system in the body. One of these systems is the urinary system.

UI suggests that it may be an early marker of the onset of frailty. In the elderly; UI is expressed as the 4th most disturbing disease after angina, difficulty in ambulation and psychiatric disorders. Among the UI subtypes, stress urinary incontinence and urge urinary incontinence are the most common and urge urinary incontinence is seen especially in the elderly.

UI occurs as a result of deterioration in pelvic floor structure functions.Obesity is the best known and potentially the most modifiable risk factor for the development of UI, leading to pelvic floor deficiencies. There is a strong and positive relationship between obesity and urinary incontinence.

Compared with patients of normal weight, obese patients are approximately twice as likely to present with urinary incontinence.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to 85 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Standardized Mini Mental Test (SMMT) total score of 24 and above,
  • •30 ≥ BMI ≥ 34.9 (obesity class 1) obese,
  • •65 years and older,
  • •Those experiencing stress or urge urinary incontinence,
  • •Able to use smart mobile phone, use Whatsapp application,
  • •Those who do not have a health problem that prevents them from doing Kegel exercises.

Exclusion Criteria

  • •Individuals who do not meet the inclusion criteria,
  • •Those with a history of incontinence surgery,
  • •Those who are morbidly obese,
  • •Having neurological and psychiatric disease,
  • •with pelvic organ prolapse,
  • •Having a disease affecting the genital and urinary system,
  • •those who cannot be communication.

Arms & Interventions

experimental:educt

Experimental

Training on improving the quality of life, coping with incontinence and kegel exercises will be given to obese elderly people over 65 years of age with urinary incontinence in the experimental group.

Face-to-face training will be given to the elderly in the experimental group for a total of 5 weeks, once a week day (60 minutes). In the 4th week, reminder messages will be started over the phone. The 4th week kegel exercise chart and nutrition list will be given. In the 5th week, kegel exercise dance will be watched. Sending reminder messages from the phone will continue for 3 months.

Intervention: improving quality of life, coping with urinary incontinence and kegel exercise training (Behavioral)

active comparator, control group

No Intervention

The elderly in the control group will not be interfered with.

Outcomes

Primary Outcomes

Urogenital distress inventory

Time Frame: Time Frame: 17 weeks

The Turkish validity study of the urogenital distress inventory (UDI) was performed by Çam et al (2007). The scale is an inquiry form used to measure the presence of lower urinary tract symptoms and the degree of distress. UDI-6 consists of six questions and is graded on a four-point Likert scale. The first two questions are aimed at revealing irritative symptoms (urgency, frequency and pain), while the 3rd and 4th questions are aimed at stress symptoms, and the last two questions are for obstructive or voiding symptoms. Six questions ask about frequent urination, leakage due to a sense of urgency, leakage related to activity, coughing or sneezing, a small amount of leakage, difficulty in emptying the bladder, and pain or discomfort in the lower abdomen or genital area.

Incontinence Quality of Life - I-QOL Scale

Time Frame: Time Frame: 17 weeks

The incontinence quality of life scale was developed by Wagner et al. in the USA in 1996 to determine the quality of life in patients with urinary incontinence. The validity and reliability of I-QOL in our country was done by Özerdoğan (2003). It has three sub-areas: limitation of behavior, psychosocial influence, and social isolation. In the Incontinence Quality of Life Scale (I-QOL), all items are evaluated on a five-point Likert-type scale as 1=a lot, 2=a lot, 3=moderate, 4=somewhat, 5=not at all. A maximum of 110 points can be obtained from the overall scale, 40 points from the behavior limitation sub-dimension, 45 points from the psychosocial impact sub-dimension, and 25 points from the social isolation sub-dimension. High scores indicate better quality of life than low scores.

Loneliness Scale for the Elderly:

Time Frame: Time Frame: 17 weeks

The scale was developed by de Jong Gierveld and Kamphuis in 1985 and revised by de Jong Gierveld and van Tilburg in 1999. The Turkish validity-reliability study of the scale was carried out by Akgül and Yeşilyaprak (2015). The scale, which has 11 questions in total, consists of 2 sub-dimensions. 6 items (2,3,5,6,9,10) of the scale consist of negative statements measuring emotional loneliness, and 5 items (1,4,7,8,11) consist of positive statements that measure social loneliness. The extent to which the situation contained in each statement in the scale is experienced by the person is determined by a 3-point Likert type rating. The rating is 0= yes, 1= maybe, 2= no. The lowest score on the scale is 0, and the highest score is 22. Total loneliness can be divided into four levels: Level 1; not alone / does not feel lonely (score 0-4); Level 2; acceptable loneliness (5-14 points); Level 3; very lonely (15-18 points); Level 4; It is very intense loneliness (score 19-22).

Incontinence Awareness and Attitude Scale

Time Frame: Time Frame: 17 weeks

The scale was developed by Avcı et al in 2017. The answers given to each statement in the scale are in the form of strongly agree, agree, undecided, disagree, strongly disagree, and the scale is in a 5-point Likert type. The scale does not have a total score. For the sub-dimension of coping with urinary incontinence, a minimum of 6 and a maximum of 30 are taken. In this study, only the coping with urinary incontinence sub-dimension of this scale will be used.

Health Belief Scale for Urinary Incontinence and Kegel Exercise:

Time Frame: Time Frame: 17 weeks

The scale was developed by Avcı and Yıldırım (2019) based on the health belief model to determine individuals' beliefs about urinary incontinence and kegel exercises. The scale consists of 49 questions in 5-point Likert type and 6 sub-dimensions. The scale does not have a total score. In this study, this scale; Kegel exercise perception of benefit sub-dimension, kegel exercise disability perception sub-dimension and self-efficacy sub-dimension will be used. The scores obtained from the sub-dimensions and sub-dimensions of the scale are as follows: between 7-35 points for the perception of benefit sub-dimension of kegel exercise; Kegel exercise varies between 9-45 points for the perception of disability sub-dimension and between 5-25 points for the self-efficacy sub-dimension. Higher scores indicate that benefits are perceived as high for the perception of benefit, and obstacles are perceived as high for the perception of obstacles.

Secondary Outcomes

  • Body Mass İndex Measurement (Weıght and Heıght) (Time Frame: 17 Weeks)(17 weeks)

Investigators

Sponsor
Ondokuz Mayıs University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Şeyma SOYANIT ERASLAN

research assistant

Ondokuz Mayıs University

Study Sites (1)

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