Female Sexual DysfunctionNCT05806424
Investigation of Awareness Levels of Women Living in Turkey About Kegel Exercises and Pelvic Floor Muscles
An observational study of Female Sexual Dysfunction, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Pelvic floor disorders affect millions of women and their lives in our country and around the world. Along with many factors such as age, obesity, menopause, smoking, number of births and mode of delivery, there is an increase in the prevalence of pelvic floor disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Sexual Dysfunction
- How many people
- 182 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Oct 2023to 13 Dec 2023
- Phase
- Observational
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals who will participate in the study will be reached through online platforms. A questionnaire will be sent to the participants via the Google search engine and they will be asked to fill it out.
Who may be able to join
- Living in Turkey
- Women aged 18 and over
- Having an active sex life
Who cannot join
- Having a disease affecting the pelvic floor muscles
- Having pelvic surgery in the last 6 months
- Being receiving sexual therapy
Trial locations and contacts
1 site in 1 country.
About this study
Pelvic floor disorders affect millions of women and their lives in our country and around the world. Along with many factors such as age, obesity, menopause, smoking, number of births and mode of delivery, there is an increase in the prevalence of pelvic floor disorders. Pelvic floor disorders (urinary/fecal incontinence, pelvic organ prolapse, chronic pelvic pain, sexual dysfunction) negatively affect women, their families, caregivers of individuals who cannot meet their own needs, and society in many ways. Treatment of pelvic floor disorders is very costly on a community basis. An effective process is carried out with the use of non-pharmacological traditional and complementary therapies instead of invasive or pharmacological treatment in the early period of the treatment of symptoms of pelvic floor disorders.
Read the detailed description
Pelvic floor muscle training has a positive effect on voiding functions by strengthening the urogenital sphincter muscle. One of the commonly used methods for pelvic floor muscle training is the so-called Kegel exercise.
Sexual life, with its personal and social aspects, is an inseparable part of human beings in general, it is one of the most important factors in human life and happiness, especially in family life. Sexuality positively integrates and enriches the somatic, emotional, intellectual and social aspects of individuals, and develops personality, communication and love.
Kegel exercises; It is a method for strengthening the muscles that fix the bladder, intestines and genital organs in the pelvis and control their movements. These are tightening and relaxation exercises that strengthen the pelvic muscles. Like all voluntary muscles, the pelvic floor muscles are muscles that get stronger and develop as they work. Women of all ages need to have strong pelvic floor muscles.
- Conditions
- Female Sexual Dysfunction
- Keywords
- exercise, kegel exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pelvic muscle awareness | Not described | |
| not pelvic muscle awareness | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic Information:
It was used to measure the general knowledge of the participants and their knowledge of knowing and applying Kegel exercises.
Whether there is information about the pelvic floor muscles and Kegel exercises, the source of this information, whether the exercises are applied, which one is applied, the reason for the application, how long it is applied, whether the application is continued, from whom the training is received, how it is applied, whether it has positive effects. It is a questionable scale.
Measured: one day
Female sexual function scale (FSFI)
The sexual functions of each subject included in the study were analyzed using the Female Sexual Function Index (FSFI). In the structure of the scale; There are 6 sub-dimensions: desire, arousal, lubrication (lubrication, wetting), orgasm, satisfaction and pain. Each item is scored from zero to 5. Accordingly, the highest raw score that can be obtained from the scale is 95.0 and the lowest raw score is 40. The reliability of the test was evaluated in two ways; Internal consistency and test-retest reliability were determined separately for 6 sub-dimensions with Cronbach's Alpha and their values were found to be 0.82 and higher.
Measured: one day
Sexual Life Quality Scale- Female:
Each item is expected to be answered by considering the sexual life in the last four weeks. In scoring the scale, each question is scored between 1 and 6. The range of points that can be obtained from the scale is between 18 and 108. The scores of items 1, 5, 9, 13 and 18 must be reversed before the total score can be calculated. In order to convert the total scale score to 100 (raw score-18 from the scale), the formula x100/90 should be used. A high score from the scale indicates that the quality of sexual life is good.
Measured: one day
Secondary outcomes (1)
Beck Anxiety Scale
It is a self-report scale that determines the frequency of anxiety symptoms experienced by individuals. It is a Likert-type scale consisting of 21 items and scored between 0-3. The high scores obtained from the scale indicate the severity of the anxiety experienced by the individual. If the scores obtained from the scale are in the range of 0-7 points, it is considered as minimal anxiety / normal, between 8-15 points as mild anxiety, between 16-25 points as moderate anxiety, and between 26-63 points as severe anxiety. Although it is not certain, it is generally recommended to start medical treatment for individuals above 16 points. The treatment should be given by looking at the clinical condition of the patient as well as the score obtained from the scale.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start21 Oct 2023
- Primary completion21 Oct 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female Sexual DysfunctionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806424
- Sponsor's protocol ID
- Kegel Exercises Pelvic Floor
- Status last verified
- Nov 2025
- First submitted
- 28 Mar 2023
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khosravi A, Riazi H, Simbar M, Montazeri A. Effectiveness of Kegel exercise and lubricant gel for improving sexual function in menopausal women: A randomized trial. Eur J Obstet Gynecol Reprod Biol. 2022 Jul;274:106-112. doi: 10.1016/j.ejogrb.2022.05.022. Epub 2022 May 21.
PubMed 35640438
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Awareness Levels of Women Living in Turkey About Kegel Exercises and Pelvic Floor Muscles
- ClinicalTrials.gov ID
- NCT05806424
- Acronym / sponsor ID
- Kegel Exercises Pelvic Floor
- Conditions
- Female Sexual Dysfunction
- Keywords
- exercise, kegel exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 21 Oct 2023 (actual)
- Primary completion
- 21 Oct 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 10 Apr 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.
Pelvic floor disorders affect millions of women and their lives in our country and around the world. Along with many factors such as age, obesity, menopause, smoking, number of births and mode of delivery, there is an increase in the prevalence of pelvic floor disorders. Pelvic floor disorders (urinary/fecal incontinence, pelvic organ prolapse, chronic pelvic pain, sexual dysfunction) negatively affect women, their families, caregivers of individuals who cannot meet their own needs, and society in many ways. Treatment of pelvic floor disorders is very costly on a community basis. An effective process is carried out with the use of non-pharmacological traditional and complementary therapies instead of invasive or pharmacological treatment in the early period of the treatment of symptoms of pelvic floor disorders.
Detailed description
Pelvic floor muscle training has a positive effect on voiding functions by strengthening the urogenital sphincter muscle. One of the commonly used methods for pelvic floor muscle training is the so-called Kegel exercise.
Sexual life, with its personal and social aspects, is an inseparable part of human beings in general, it is one of the most important factors in human life and happiness, especially in family life. Sexuality positively integrates and enriches the somatic, emotional, intellectual and social aspects of individuals, and develops personality, communication and love.
Kegel exercises; It is a method for strengthening the muscles that fix the bladder, intestines and genital organs in the pelvis and control their movements. These are tightening and relaxation exercises that strengthen the pelvic muscles. Like all voluntary muscles, the pelvic floor muscles are muscles that get stronger and develop as they work. Women of all ages need to have strong pelvic floor muscles.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pelvic muscle awareness | – | – |
| not pelvic muscle awareness | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who will participate in the study will be reached through online platforms. A questionnaire will be sent to the participants via the Google search engine and they will be asked to fill it out.
Key inclusion criteria (3 listed)
- Living in Turkey
- Women aged 18 and over
- Having an active sex life
Key exclusion criteria (3 listed)
- Having a disease affecting the pelvic floor muscles
- Having pelvic surgery in the last 6 months
- Being receiving sexual therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic Information:
Time frame: one day
It was used to measure the general knowledge of the participants and their knowledge of knowing and applying Kegel exercises. Whether there is information about the pelvic floor muscles and Kegel exercises, the source of this information, whether the exercises are applied, which one is applied, the reason for the application, how long it is applied, whether the application is continued, from whom the training is received, how it is applied, whether it has positive effects. It is a questionable scale.
Female sexual function scale (FSFI)
Time frame: one day
The sexual functions of each subject included in the study were analyzed using the Female Sexual Function Index (FSFI). In the structure of the scale; There are 6 sub-dimensions: desire, arousal, lubrication (lubrication, wetting), orgasm, satisfaction and pain. Each item is scored from zero to 5. Accordingly, the highest raw score that can be obtained from the scale is 95.0 and the lowest raw score is 40. The reliability of the test was evaluated in two ways; Internal consistency and test-retest reliability were determined separately for 6 sub-dimensions with Cronbach's Alpha and their values were found to be 0.82 and higher.
Sexual Life Quality Scale- Female:
Time frame: one day
Each item is expected to be answered by considering the sexual life in the last four weeks. In scoring the scale, each question is scored between 1 and 6. The range of points that can be obtained from the scale is between 18 and 108. The scores of items 1, 5, 9, 13 and 18 must be reversed before the total score can be calculated. In order to convert the total scale score to 100 (raw score-18 from the scale), the formula x100/90 should be used. A high score from the scale indicates that the quality of sexual life is good.
1 secondary outcome
Beck Anxiety Scale
Time frame: one day
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 17 Nov 2025.
- Background: PubMed 35640438Khosravi A, Riazi H, Simbar M, Montazeri A. Effectiveness of Kegel exercise and lubricant gel for improving sexual function in menopausal women: A randomized trial. Eur J Obstet Gynecol Reprod Biol. 2022 Jul;274:106-112. doi: 10.1016/j.ejogrb.2022.05.022. Epub 2022 May 21.
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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?
An observational study of Female Sexual Dysfunction, run by Istanbul Medipol University Hospital 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?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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 17 Nov 2025. 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?
Demographic Information: (time frame: one day). 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?
On the ClinicalTrials.gov record for NCT05806424, which also lists 1 linked publication.
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 17 Nov 2025.