- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06896500
Investigation Of The Effects Of Kegel Exercises On Vaginal Flatus Among Postpartum Women (KEGEL-VF)
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).
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey, 34810
- Istanbul Medipol University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- being over four months postpartum,
- current pregnancy,
- presence of pelvic infection,
- inability to indicate whether there is vaginal flatus,
- the presence of gynecological cancer.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kegel Exercise Group
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.
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Kegel exercises performed three times daily in different positions (supine, sitting, and standing) for three weeks, followed by a six-week home program
|
|
No Intervention: Control Group
Participants in this group did not perform any pelvic floor exercises and continued their routine postpartum activities.
No intervention was applied
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline to at least 6 weeks postpartum
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ayse Kavasoglu Kaya, M.D., Medipol University
Publications and helpful links
General 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.
- Neels 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-772.02-3326 (Registry Identifier: Istanbul Medipol University Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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Clinical Study Report
Information identifier: Ethics Committee Application
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Informed Consent Form
Information identifier: informed consent form
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Forms
Information identifier: Vaginal flatus status form
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Study Protocol
Information identifier: study main data
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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