Urinary IncontinenceNCT06096818
Kegel and Abdominal Exercises on Urinary Incontinence Severity, Quality of Life, and Sleep Quality in Menopausal Women
A study testing Experimental Group: Kegel exercises and abdominal exercises in people with Urinary Incontinence and Postmenopausal Symptoms, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Postmenopausal Symptoms, Sleep Quality
- What is being tested?
- Experimental Group: Kegel exercises and abdominal exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 20 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpaşa
Istanbul, Marmara Region, 34325
About this study
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
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.
Read more
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.
Read the 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
- Being tested
- Experimental Group: Kegel exercises and abdominal exercises, Control Group: Kegel exercises
- Keywords
- Menopause, Female, Urinary incontinence, Kegel Exercise, Abdomen Exercise
- Medical subject headings
- Urinary Incontinence, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Group: Kegel exercises and abdominal exercisesBehavioural
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 exercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Kegel exercises and abdominal exercises | Experimental | Kegel exercises and abdominal exercises training has given to this group Receives: Behavioral: Experimental Group: Kegel exercises and abdominal exercises; Behavioral: Control Group: Kegel exercises |
| Control Group: Kegel exercises | No intervention | Kegel exercises exercises training has given to this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The change in the International Consultation on Incontinence Questionnaire-Short Form score of the participants in 3 months was evaluated.
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 May 2023
- Primary completion15 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Responsible party
- Principal investigator, Meltem Kaydırak, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096818
- Sponsor's protocol ID
- B.30.2.ODM.0.20/60-164
- Status last verified
- Jan 2024
- First submitted
- 5 Oct 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06096818
- Acronym / sponsor ID
- B.30.2.ODM.0.20/60-164
- Conditions
- Urinary Incontinence, Postmenopausal Symptoms, Sleep Quality
- Keywords
- Menopause, Female, Urinary incontinence, Kegel Exercise, Abdomen Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Study start
- 1 May 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Kegel exercises and abdominal exercises | Experimental | Behavioral: Experimental Group: Kegel exercises and abdominal exercises, Behavioral: Control Group: Kegel exercisesKegel exercises and abdominal exercises training has given to this group |
| Control Group: Kegel exercises | No intervention | –Kegel exercises exercises training has given to this group |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Group: Kegel exercises and abdominal exercisesThe 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. | Behavioural | Experimental Group: Kegel exercises and abdominal exercises |
| Control Group: Kegel exercisesThe 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. | Behavioural | Experimental Group: Kegel exercises and abdominal exercises |
Primary outcome
Urinary Incontinence Severity
Time frame: The change in the International Consultation on Incontinence Questionnaire-Short Form score of the participants in 3 months was evaluated.
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
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
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group: Kegel exercises and abdominal exercises in people with Urinary Incontinence and Postmenopausal Symptoms, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Incontinence Severity (time frame: The change in the International Consultation on Incontinence Questionnaire-Short Form score of the participants in 3 months was evaluated.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.