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

Primary Purpose

Urinary Incontinence, Postmenopausal Symptoms, Sleep Quality

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Experimental Group: Kegel exercises and abdominal exercises
Control Group: Kegel exercises
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urinary Incontinence focused on measuring Menopause, Female, Urinary incontinence, Kegel Exercise, Abdomen Exercise

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Istanbul Universty - CerrahpaşaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group: Kegel exercises and abdominal exercises

Control Group: Kegel exercises

Arm Description

Kegel exercises and abdominal exercises training has given to this group

Kegel exercises exercises training has given to this group

Outcomes

Primary Outcome Measures

Urinary Incontinence Severity
70 women as assessed by International Consultation on Incontinence Questionnaire-Short Form, Change From Baseline in Urinary Incontinence Severity at 3 months. In menopausal women with urinary incontinence, performing kegel exercises and abdominal exercises together reduces the total score of the International Consultation on Incontinence Questionnaire-Short Form. The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) consisting of 6 questions was used to assess the severity, frequency, type of incontinence and its implications on quality of life. The possible scores on the scale are between 0 and 21.
Quality of life of women with urinary incontinence will be evaluated
Incontinence Impact Questionnaire (IIQ-7): This scale is reliable, consistent and valid instrument to measure of the impact of urinary incontinence, to assess the impact on quality of life in Turkish speaking women with urinary incontinence. The Likert-type scale has four dimensions: physical activity, travel, social relations and emotional health. A minimum of 0 and a maximum of 21 points can be obtained from IIQ-7. The total score and sub-dimension scores of the form are calculated on a scale of 0 - 100 points. Low scores obtained from each IIQ-7 are an indicator of increased quality of life.
Sleep Quality
Pittsburgh Sleep Quality Scale (PSQI): It is a scale to evaluate sleep quality with questions asked under seven main headings that evaluate subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, use of sleeping pills and impairment in daytime functions. The total score of the scale is between 0-21. If the total score is 5 or above, sleep quality is considered poor. High scores indicate poor sleep quality.

Secondary Outcome Measures

Full Information

First Posted
October 5, 2023
Last Updated
October 24, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Ondokuz Mayıs University
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1. Study Identification

Unique Protocol Identification Number
NCT06096818
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Ondokuz Mayıs University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Postmenopausal Symptoms, Sleep Quality
Keywords
Menopause, Female, Urinary incontinence, Kegel Exercise, Abdomen Exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Masking Description
Double (Participant, Investigator) Women who meet the inclusion criteria were included in the sample using a simple random method. Before the research numbers were produced from random.org, envelopes of the same size and characteristics were created for each participant by someone other than the researcher (IU-C, Research Assistant B.Y), and numbers between 1 and 100 were written on them. Then, considering the data losses, numbers from 1 to 100 were generated from random.org. Single-column groups were created between 1 and 100 by the help of the Random Integer Generator at the Numbers title of the Random.org website. The numbers (1 or 2) were assigned to the groups (study and control) randomly by tossing a coin. Number 1 was assigned to the control group, and number 2 to the experimental group. Experimental Group: 35 women Control Group: 35 women
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group: Kegel exercises and abdominal exercises
Arm Type
Experimental
Arm Description
Kegel exercises and abdominal exercises training has given to this group
Arm Title
Control Group: Kegel exercises
Arm Type
No Intervention
Arm Description
Kegel exercises exercises training has given to this group
Intervention Type
Behavioral
Intervention Name(s)
Experimental Group: Kegel exercises and abdominal exercises
Intervention Description
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
Intervention Name(s)
Control Group: Kegel exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Urinary Incontinence Severity
Description
70 women as assessed by International Consultation on Incontinence Questionnaire-Short Form, Change From Baseline in Urinary Incontinence Severity at 3 months. In menopausal women with urinary incontinence, performing kegel exercises and abdominal exercises together reduces the total score of the International Consultation on Incontinence Questionnaire-Short Form. The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) consisting of 6 questions was used to assess the severity, frequency, type of incontinence and its implications on quality of life. The possible scores on the scale are between 0 and 21.
Time Frame
The change in the International Consultation on Incontinence Questionnaire-Short Form score of the participants in 3 months was evaluated.
Title
Quality of life of women with urinary incontinence will be evaluated
Description
Incontinence Impact Questionnaire (IIQ-7): This scale is reliable, consistent and valid instrument to measure of the impact of urinary incontinence, to assess the impact on quality of life in Turkish speaking women with urinary incontinence. The Likert-type scale has four dimensions: physical activity, travel, social relations and emotional health. A minimum of 0 and a maximum of 21 points can be obtained from IIQ-7. The total score and sub-dimension scores of the form are calculated on a scale of 0 - 100 points. Low scores obtained from each IIQ-7 are an indicator of increased quality of life.
Time Frame
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
Title
Sleep Quality
Description
Pittsburgh Sleep Quality Scale (PSQI): It is a scale to evaluate sleep quality with questions asked under seven main headings that evaluate subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, use of sleeping pills and impairment in daytime functions. The total score of the scale is between 0-21. If the total score is 5 or above, sleep quality is considered poor. High scores indicate poor sleep quality.
Time Frame
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Istanbul Universty - Cerrahpaşa
City
Istanbul
State/Province
Marmara Region
ZIP/Postal Code
34325
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meltem Mecdi Kaydırak
Phone
+905322027786
Email
meltem.kaydirak@iuc.edu.tr
Phone
05322027786

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The information obtained from this study will be used for research purposes and personal information will be kept confidential; however, the data may be used for publication purposes. 2 years after the completion of the study, the data will be destroyed by the destruction machine belonging to the institution and will be kept locked in a closed cabinet during this period.

Learn more about this trial

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

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