Kegel and Abdominal Exercises on Urinary Incontinence Severity, Quality of Life, and Sleep Quality in Menopausal Women

NCT ID: NCT06096818

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2023-11-20

Brief Summary

The aim of this randomized, controlled experimental study is to investigate the effectiveness of Kegel exercises and abdominal exercises on urinary incontinence severity, quality of life, and sleep quality in menopausal women with stress urinary incontinence. Research Hypothesis are:

H1: Combining Kegel exercises and abdominal exercises affects urinary incontinence severity in menopausal women with stress urinary incontinence.

H2: Combining kegel exercises and abdominal exercises affects quality of life in menopausal women with stress urinary incontinence.

H3: Combining kegel exercises and abdominal exercises affects sleep quality in menopausal women with stress urinary incontinence.

Researchers will compare two groups: Kegel and abdominal exercise training is applied to the experimental group. Only kegel exercise training is applied to the control group.

The study will be conducted in a prospective, randomized, parallel group controlled design. Hypotheses will be evaluated by applying pre-test and post-tests to the groups of exercises applied for three months during the research process.

Detailed Description

Urinary incontinence is defined by the International Continence Society as involuntary urinary leakage that causes social and hygienic problems and can be objectively demonstrated. Urinary incontinence is an important health problem that is more common in women than men. As a matter of fact, urinary incontinence has also been recognized as a common public health problem affecting women's physical, psychological, social, and economic well-being. This problem may worsen, especially during menopause, as estrogen levels decrease and pelvic floor muscles and ligaments atrophy.

Women spend a long period of their lives in menopause. Therefore, the urinary incontinence they experience during this period affects their lives in many dimensions (insecurity, deterioration in sexual life, insomnia, etc.). As a matter of fact, one of the important conservative treatments for urinary incontinence is Kegel exercises. The fact that it has no risks or costs and that women can do it wherever and whenever they want makes this exercise advantageous. It has been reported that abdominal muscle exercises (bridge building and abdominal curling exercises, etc.), along with Kegel exercises, significantly affect the pelvic floor muscles. However, the studies are mostly on the samples of pregnant, postpartum, and reproductive-age women, and studies on women in the menopausal period are needed. This study will increase awareness of the importance and effect of regular kegel and abdominal exercises in menopausal women with urinary incontinence.

Deterioration in sleep quality and chronic insomnia are also quite common (11.8% - 56.6%) problems in menopause. One of the factors that cause sleep problems is urinary incontinence, which causes frequent trips to the toilet and interrupts night sleep. Researchers predicted that reducing the frequency of urinary incontinence experienced by women would positively affect their sleep quality.

Data Collection: The data will be collected by the researcher by face-to-face interview method in a total of 12 weeks, three face-to-face interviews, each interview is experimental group 30 minutes - the control group 20 minutes. Kegel and abdominal exercise training is applied to the experimental group. Only kegel exercise training is applied to the control group.

Statistical Methods to be Used: The Statistical Package for the Social Sciences program will be used to analyze the obtained data. The conformity of the data to the normal distribution will be examined by considering the Shapiro-Wilk test. Parametric methods will be used to analyze normally distributed variables, and non-parametric methods will be used to analyze non-normally distributed variables. Independent-sample T-test, Mann-Whitney U (Exact) test, and T-test for Dependent Groups, Wilcoxon test will be used to compare two independent groups. Pearson correlation Spearman's tests will be used to examine the correlations of the variables with each other. Comparison of categorical data will be tested with Pearson Chi-square and FisherExact tests.

Conditions

Urinary Incontinence; Postmenopausal Symptoms; Sleep Quality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group: Kegel exercises and abdominal exercises

Kegel exercises and abdominal exercises training has given to this group

Group Type: EXPERIMENTAL

Experimental Group: Kegel exercises and abdominal exercises

Intervention Type: BEHAVIORAL

The training was planned to occur 3 times in a 12-week period (first meeting+6thweek+12th week). Each training: approx. 30 min.

First session:Meeting the woman Consent and data collection forms (Descriptive characteristics of women, Incontinence Impact Questionnaire-Short Form,International Urinary Incontinence Consultation Questionnaire-Short Form,Pittsburgh Sleep Quality Scale) Information about stress urinary incontinence is given The woman is given kegel exercise and abdominal exercise training face to face by the researchers.

Kegel and abdominal exercise application chart is explained and given as homework.

Relevant brochure is provided. Second Session:Greeting-Kegel and abdominal exercise application chart is being checked Kegel and abdominal exercises are performed again under the supervision of the researcher.

Third session:Greeting-Kegel and abdominal exercise application chart is being checked Data collection tools are being refilled.

Control Group: Kegel exercises

Intervention Type: BEHAVIORAL

The training was planned to occur 3 times in a 12-week period (first meeting+6th week+12th week). Each training: approx. 20 min.

First session: Meeting the woman Consent and data collection forms (Descriptive characteristics of women, Incontinence Impact Questionnaire-Short Form, International Urinary Incontinence Consultation Questionnaire-Short Form, Pittsburgh Sleep Quality Scale).

Information about stress urinary incontinence is given The woman is given kegel exercise training face to face by the researchers. Kegel exercise application chart is explained and given as homework. Relevant brochure is provided. Second Session:Greeting-Kegel exercise application chart is being checked Kegel exercises are performed again under the supervision of the researcher. Third session:Greeting-Kegel exercise application chart is being checked Data collection tools are being refilled.

Control Group: Kegel exercises

Kegel exercises exercises training has given to this group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Experimental Group: Kegel exercises and abdominal exercises

The training was planned to occur 3 times in a 12-week period (first meeting+6thweek+12th week). Each training: approx. 30 min.

First session:Meeting the woman Consent and data collection forms (Descriptive characteristics of women, Incontinence Impact Questionnaire-Short Form,International Urinary Incontinence Consultation Questionnaire-Short Form,Pittsburgh Sleep Quality Scale) Information about stress urinary incontinence is given The woman is given kegel exercise and abdominal exercise training face to face by the researchers.

Kegel and abdominal exercise application chart is explained and given as homework.

Relevant brochure is provided. Second Session:Greeting-Kegel and abdominal exercise application chart is being checked Kegel and abdominal exercises are performed again under the supervision of the researcher.

Third session:Greeting-Kegel and abdominal exercise application chart is being checked Data collection tools are being refilled.

Intervention Type: BEHAVIORAL

Control Group: Kegel exercises

The training was planned to occur 3 times in a 12-week period (first meeting+6th week+12th week). Each training: approx. 20 min.

First session: Meeting the woman Consent and data collection forms (Descriptive characteristics of women, Incontinence Impact Questionnaire-Short Form, International Urinary Incontinence Consultation Questionnaire-Short Form, Pittsburgh Sleep Quality Scale).

Information about stress urinary incontinence is given The woman is given kegel exercise training face to face by the researchers. Kegel exercise application chart is explained and given as homework. Relevant brochure is provided. Second Session:Greeting-Kegel exercise application chart is being checked Kegel exercises are performed again under the supervision of the researcher. Third session:Greeting-Kegel exercise application chart is being checked Data collection tools are being refilled.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Able to read and write,
• Without hearing difficulty or vision loss, Able to communicate,
• Those who have not received any treatment for incontinence,
• Having a body mass index (BMI) < 30,
• Those who have stage 0-I-II stress urinary incontinence complaints, who have been diagnosed with stress incontinence by a physician and who do not require surgical treatment for stress incontinence,
• Women in menopause who agree to participate in the study will be included in the study.

Criteria for exclusion from the study:

• Having diabetes,
• Those who use diuretics and antihypertensive drugs,
• Having a urinary system infection,
• Those with pelvic organ prolapse,
• Having undergone incontinence surgery,
• Those with lumbar disc herniation,
• Body mass index (BMI) > 30,
• Those who have stage III-IV stress urinary incontinence complaints, have been diagnosed and require surgical treatment for stress incontinence
• Women who do not agree to participate in the study and who are not in menopause will not be included in the study.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Meltem Kaydırak

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul University - Cerrahpaşa

Istanbul, Marmara Region, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

B.30.2.ODM.0.20/60-164

Identifier Type: -

Identifier Source: org_study_id