Pelvic Floor AwarenessKEGEL-VFNCT06896500
Investigation Of The Effects Of Kegel Exercises On Vaginal Flatus Among Postpartum Women
A study testing Kegel Exercises in people with Pelvic Floor Awareness and Postpartum, run by merve yilmaz menek at 1 site in Turkey (Türkiye).
Trial summary
Title: Investigation of the Effects of Kegel Exercises on Vaginal Flatus Among Postpartum Women Brief Summary: This study aims to evaluate the effectiveness of Kegel exercises in reducing vaginal flatus among postpartum women. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Pelvic Floor Awareness, Postpartum, Postpartum Pelvic Floor Function and Symptoms
- What is being tested?
- Kegel Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jun 2022to 28 Feb 2024
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- being between the ages of 20-50,
- being postpartum at least 6 weeks after the last birth,
- having a complaint of vaginal flatus, and being willing to exercise
Who cannot join
- being over four months postpartum,
- current pregnancy,
- presence of pelvic infection,
- inability to indicate whether there is vaginal flatus,
- the presence of gynecological cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Title: Investigation of the Effects of Kegel Exercises on Vaginal Flatus Among Postpartum Women
Brief Summary:
Read more
This study aims to evaluate the effectiveness of Kegel exercises in reducing vaginal flatus among postpartum women. Vaginal flatus, the involuntary passage of air through the vagina, is a common but often underreported pelvic floor dysfunction that can affect women's quality of life.
A total of 40 postpartum women were randomly assigned to an experimental group (performing Kegel exercises) or a control group (no intervention). The experimental group performed Kegel exercises three times daily in different positions for six weeks. Vaginal flatus frequency and bother scores were assessed using a validated questionnaire, and sexual quality of life was evaluated with the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).
Read the detailed description
This study is a randomized controlled trial designed to assess the effectiveness of Kegel exercises in reducing vaginal flatus among postpartum women. Vaginal flatus, the involuntary passage of air through the vagina, is a common but often overlooked pelvic floor dysfunction that can negatively impact women's quality of life.
A total of 40 postpartum women were recruited and randomly assigned to either the experimental group, which performed Kegel exercises, or the control group, which received no intervention. Participants in the experimental group were instructed to perform Kegel exercises three times daily in different positions (supine, sitting, and standing) over six weeks. The intervention focused on strengthening the pelvic floor muscles through a combination of fast and slow contractions targeting both Type I and Type II muscle fibers.
The primary outcome measures included vaginal flatus frequency and bother scores, which were assessed using a validated questionnaire before and after the intervention. Additionally, sexual quality of life was evaluated using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).
- Being tested
- Kegel Exercises
- Keywords
- kegel exercises, pelvic floor exercises, postpartum period, vaginal gas, vaginal flatus
- Medical subject headings
- Flatulence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kegel ExercisesBehavioural
Kegel exercises performed three times daily in different positions (supine, sitting, and standing) for three weeks, followed by a six-week home program
| Study group | Role | What they receive |
|---|---|---|
| Kegel Exercise Group | Experimental | Participants in this group performed Kegel exercises three times daily in different positions (supine, sitting, and standing) for three weeks, followed by a six-week home program. The exercises targeted both type I and type II muscle fibers with fast and slow contractions. Receives: Behavioral: Kegel Exercises |
| Control Group | No intervention | Participants in this group did not perform any pelvic floor exercises and continued their routine postpartum activities. No intervention was applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Flatus Frequency Reduction
The primary outcome is the change in vaginal flatus frequency, assessed via patient-reported questionnaire before and after the intervention. Smaller values indicate less flatus, while higher values signify an increase in flatus.
Measured: Baseline to at least 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start8 Jun 2022
- Primary completion31 Dec 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor AwarenessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel-group, randomized controlled trial with two arms: an experimental group performing Kegel exercises and a control group receiving no intervention
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- merve yilmaz menek
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Medipol University Hospital
- Responsible party
- Sponsor-investigator, merve yilmaz menek, Istanbul Medipol University Hospital
- Investigators
- Ayse Kavasoglu Kaya, M.D., Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896500
- Sponsor's protocol ID
- E-10840098-772.02-3326
- Other IDs
- E-10840098-772.02-3326
- Acronym
- KEGEL-VF
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, I will not share IPD
Publications
Lau HH, Su TH, Chen YY, Huang WC. The Prevalence of Vaginal Flatus in Women With Pelvic Floor Disorders and Its Impact on Sexual Function. J Sex Med. 2021 Mar;18(3):487-492. doi: 10.1016/j.jsxm.2020.12.008. Epub 2021 Jan 24.
PubMed 33504467Neels H, Pacquee S, Shek KL, Gillor M, Caudwell-Hall J, Dietz HP. Is vaginal flatus related to pelvic floor functional anatomy? Int Urogynecol J. 2020 Dec;31(12):2551-2555. doi: 10.1007/s00192-020-04371-9. Epub 2020 Jun 11.
PubMed 32529562
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Of The Effects Of Kegel Exercises On Vaginal Flatus Among Postpartum Women
- ClinicalTrials.gov ID
- NCT06896500
- Acronym / sponsor ID
- KEGEL-VF / E-10840098-772.02-3326
- Keywords
- kegel exercises, pelvic floor exercises, postpartum period, vaginal gas, vaginal flatus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- merve yilmaz menekUniversity, hospital or other
- Collaborators
- Istanbul Medipol University Hospital
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 26 Mar 2025 (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.
Title: Investigation of the Effects of Kegel Exercises on Vaginal Flatus Among Postpartum Women
Brief Summary:
This study aims to evaluate the effectiveness of Kegel exercises in reducing vaginal flatus among postpartum women. Vaginal flatus, the involuntary passage of air through the vagina, is a common but often underreported pelvic floor dysfunction that can affect women's quality of life.
A total of 40 postpartum women were randomly assigned to an experimental group (performing Kegel exercises) or a control group (no intervention). The experimental group performed Kegel exercises three times daily in different positions for six weeks. Vaginal flatus frequency and bother scores were assessed using a validated questionnaire, and sexual quality of life was evaluated with the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).
Detailed description
This study is a randomized controlled trial designed to assess the effectiveness of Kegel exercises in reducing vaginal flatus among postpartum women. Vaginal flatus, the involuntary passage of air through the vagina, is a common but often overlooked pelvic floor dysfunction that can negatively impact women's quality of life.
A total of 40 postpartum women were recruited and randomly assigned to either the experimental group, which performed Kegel exercises, or the control group, which received no intervention. Participants in the experimental group were instructed to perform Kegel exercises three times daily in different positions (supine, sitting, and standing) over six weeks. The intervention focused on strengthening the pelvic floor muscles through a combination of fast and slow contractions targeting both Type I and Type II muscle fibers.
The primary outcome measures included vaginal flatus frequency and bother scores, which were assessed using a validated questionnaire before and after the intervention. Additionally, sexual quality of life was evaluated using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a parallel-group, randomized controlled trial with two arms: an experimental group performing Kegel exercises and a control group receiving no intervention
| Arm | Type | Receives |
|---|---|---|
| Kegel Exercise Group | Experimental | Behavioral: Kegel ExercisesParticipants in this group performed Kegel exercises three times daily in different positions (supine, sitting, and standing) for three weeks, followed by a six-week home program. The exercises targeted both type I and type II muscle fibers with fast and slow contractions. |
| Control Group | No intervention | –Participants in this group did not perform any pelvic floor exercises and continued their routine postpartum activities. No intervention was applied |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- being between the ages of 20-50,
- being postpartum at least 6 weeks after the last birth,
- having a complaint of vaginal flatus, and being willing to exercise
Key exclusion criteria (5 listed)
- being over four months postpartum,
- current pregnancy,
- presence of pelvic infection,
- inability to indicate whether there is vaginal flatus,
- the presence of gynecological cancer.
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 |
|---|---|---|
| Kegel ExercisesKegel exercises performed three times daily in different positions (supine, sitting, and standing) for three weeks, followed by a six-week home program | Behavioural | Kegel Exercise Group |
Primary outcome
Vaginal Flatus Frequency Reduction
Time frame: Baseline to at least 6 weeks postpartum
The primary outcome is the change in vaginal flatus frequency, assessed via patient-reported questionnaire before and after the intervention. Smaller values indicate less flatus, while higher values signify an increase in flatus.
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 26 Mar 2025.
- Results publication: PubMed 33504467Lau HH, Su TH, Chen YY, Huang WC. The Prevalence of Vaginal Flatus in Women With Pelvic Floor Disorders and Its Impact on Sexual Function. J Sex Med. 2021 Mar;18(3):487-492. doi: 10.1016/j.jsxm.2020.12.008. Epub 2021 Jan 24.
- Results publication: PubMed 32529562Neels H, Pacquee S, Shek KL, Gillor M, Caudwell-Hall J, Dietz HP. Is vaginal flatus related to pelvic floor functional anatomy? Int Urogynecol J. 2020 Dec;31(12):2551-2555. doi: 10.1007/s00192-020-04371-9. Epub 2020 Jun 11.
- Individual participant dataSharing planned: No. No, I will not share IPD
Related trials for Pelvic Floor Awareness
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Pain Neuroscience Education and Basic Body Awareness Therapy in Women With Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome, Female
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.
Ayse Kavasoglu Kaya, M.D. principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kegel Exercises in people with Pelvic Floor Awareness and Postpartum, run by merve yilmaz menek 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 5 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 26 Mar 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?
Vaginal Flatus Frequency Reduction (time frame: Baseline to at least 6 weeks postpartum). 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 NCT06896500, which also lists 2 linked publications.
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 26 Mar 2025.