NCT06896500

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 13, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

1.6 years

First QC Date

March 13, 2025

Last Update Submit

March 19, 2025

Conditions

Keywords

kegel exercisespelvic floor exercisespostpartum periodvaginal gasvaginal flatus

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to at least 6 weeks postpartum

Study Arms (2)

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.

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

Interventions

Kegel ExercisesBEHAVIORAL

Kegel exercises performed three times daily in different positions (supine, sitting, and standing) for three weeks, followed by a six-week home program

Kegel Exercise Group

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly individuals who are biologically female and identify as femaleare eligible to participate
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • being over four months postpartum,
  • current pregnancy,
  • presence of pelvic infection,
  • inability to indicate whether there is vaginal flatus,
  • the presence of gynecological cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 34810, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Flatulence

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ayse Kavasoglu Kaya, M.D.

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and outcome assessors were blinded to group allocation to prevent bias insubjective evaluations
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a parallel-group, randomized controlled trial with two arms: an experimental group performing Kegel exercises and a control group receiving no intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
sponsor investigator

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 26, 2025

Study Start

June 8, 2022

Primary Completion

December 31, 2023

Study Completion

February 28, 2024

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

No, I will not share IPD

Available IPD Datasets

Clinical Study Report (Ethics Committee Application)Access
Informed Consent Form (informed consent form)Access
Forms (Vaginal flatus status form)Access
Study Protocol (study main data)Access

Locations