Clinical trial NCT06096818: Kegel and Abdominal Exercises on Urinary Incontinence Severity, Quality of Life, and Sleep Quality in Menopausal Women
Official title: The Effectiveness of Kegel Exercises and Abdominal Exercises on Stress Urinary Incontinence Severity, Quality of Life, and Sleep Quality In Menopausal Women With Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Postmenopausal Symptoms
Sleep Quality
Keywords: Menopause
Female
Urinary incontinence
Kegel Exercise
Abdomen Exercise
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Ondokuz Mayıs University
First posted: 2023-10-24
Enrollment: 70
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Type of Study: This study is a randomized controlled trial. The pre-test-post-test has be carried out with a pattern.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Criteria for inclusion in the study:

* 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.

Primary outcomes:
measure: Urinary Incontinence Severity
timeFrame: The change in the International Consultation on Incontinence Questionnaire-Short Form score of the participants in 3 months was evaluated.
measure: Quality of life of women with urinary incontinence will be evaluated
timeFrame: The change in the incontinence Impact Questionnaire-IIQ-7 score of the participants in 3 months was evaluated. Participants were expected to have an decrease in their scores during this time
measure: Sleep Quality
timeFrame: The change in the participants' sleep quality at 3 months was evaluated with The Pittsburgh Sleep Quality Scale. Participants were expected to have an decrease in their scores during this time.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University - Cerrahpaşa
state: Marmara Region
Study officials:
References: