Prevalence of Pelvic Floor Dysfunctions in Female Badminton Athletes and Sedentary

June 11, 2024 updated by: Lara Díaz Álvarez, University of Alcala

Prevalence of Pelvic Floor Dysfunctions in Female Badminton Athletes and Sedentary: Protocol of an Observational Case-Control Study

The objective of the study is to know the prevalence of pelvic floor dysfunctions in female badminton athletes compared to sedentary women, and the hypothesis is that the prevalence of pelvic floor dysfunctions is going to be higher in female badminton athletes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study, all participants giving written informed consent will complete the personal data questionnaire and the questionnaires validated to Spanish population "International Consultation on Incontinence Questionnaire-Short Form" (ICIQ-SF), "Pelvic Floor Distress Inventory Short Form" (PFDI-20), "Female Sexual Function Index" (FSFI) and the SF-12 questionnaire. After that, inclusion and exclusion criteria will be assessed, and participants will be allocated into cases and controls group. Both groups will undergo the same procedures. Firstly, the evaluation of stress urinary incontinence and pelvic organ prolapse signs will be performed by using the cough stress test and Pelvic Organ Prolapse Quantification System; and secondly, the evaluation of pelvic floor muscle strength by using manometry.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Madrid
      • Alcalá De Henares, Madrid, Spain, 28805
        • Faculty of Nursing and Physiotherapy of the University of Alcala
        • Contact:
        • Principal Investigator:
          • Lara Díaz Álvarez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women from Comunidad de Madrid (Spain) who want to participate and fullfil the inclusion criteria.

In the cases group, women from badminton clubs register at the "Federación Madrileña de Bádminton" and University clubs or not register in this federation.

Description

Inclusion Criteria:

  • Cases: women who practice recreational badminton and/or are federated and compete.
  • Controls: sedentary women and/or do not meet the recommendations of the World Health Organization (150-300 minutes of moderate-intensity aerobic physical activity or 75-150 minutes of vigorous-intensity aerobic physical activity).

Exclusion Criteria:

  • Connective tissue diseases (Ehlers-Danlos syndrome, Marfan syndrome or hypermobility syndrome).
  • Pregnant at the time of the study.
  • Give birth in the last 12 months.
  • Not understanding Spanish language.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
Female badminton athletes
Other: Assessment of pelvic floor dysfunctions' symptoms and sings, pelvic floor muscle strength and quality of life
It will be assessed the presence of urinary incontinence, anal incontinence, pelvic organ prolapse and female sexual dysfunction' symptoms by using the questionaries validated to Spanish population "International Consultation on Incontinence Questionnaire-Short Form", "Pelvic Floor Distress Inventory Short Form" and "Female Sexual Function Index"; in addition, the sign of stress urinary incontinence and pelvic organ prolapse will be assessed by using the cough stress test and Pelvic Organ Prolapse Quantification System, the pelvic floor muscle strength by using manometry, and quality of life by using SF-12 questionnaire.
Controls
Sedentary women
Other: Assessment of pelvic floor dysfunctions' symptoms and sings, pelvic floor muscle strength and quality of life
It will be assessed the presence of urinary incontinence, anal incontinence, pelvic organ prolapse and female sexual dysfunction' symptoms by using the questionaries validated to Spanish population "International Consultation on Incontinence Questionnaire-Short Form", "Pelvic Floor Distress Inventory Short Form" and "Female Sexual Function Index"; in addition, the sign of stress urinary incontinence and pelvic organ prolapse will be assessed by using the cough stress test and Pelvic Organ Prolapse Quantification System, the pelvic floor muscle strength by using manometry, and quality of life by using SF-12 questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary incontinence symptoms
Time Frame: 1 assessment when participants are recruited
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF): total score greater than 0 is positive for urinary incontinence
1 assessment when participants are recruited
Anal incontinence and pelvic organ prolapse symptoms
Time Frame: 1 assessment when participants are recruited
Pelvic Floor Distress Inventory Short Form (PFDI-20): item 3 pelvic organ prolapse symptom, item 9 solid fecal incontinence symptom, item 10 liquid fecal incontinence symptom, item 11 flatal incontinence symptom, item 13 fecal (rectal) urgency symptom. Affirmative answer is positive for the symptoms.
1 assessment when participants are recruited
Female sexual dysfunction symptoms
Time Frame: 1 assessment when participants are recruited
Female Sexual Function Index (FSFI): total score less or equal to 26 points is positive for female sexual dysfunction risk
1 assessment when participants are recruited

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress urinary incontinence sign
Time Frame: 1 assessment when participants are recruited
Cough stress test: with a comfortable sensation of a full bladder (200-400 mL), it is considered positive when a leakage of urine is visualized at the urethral meatus at the same time as coughing (between 1 and 4 repetitions). If the result is negative, the test should be repeated in a standing position (accessory test).
1 assessment when participants are recruited
Pelvic organ prolapse sign
Time Frame: 1 assessment when participants are recruited
Pelvic Organ Prolapse Quantification System: the patient with empty bladder and rectum (if possible), the presence, type and stage of pelvic organ prolapse will be assessed by a gynecologist.
1 assessment when participants are recruited
Pelvic floor muscle strength
Time Frame: 1 assessment when participants are recruited
Manometry: probe will be inserted, calibrated to 0 and asked to perform 3 maximum voluntary contractions of the pelvic floor muscle, 10 seconds break in between, after the verbal instruction "squeeze and lift the probe as strongly as possible". The total score will be the average of the three values. Measured in centimetres of water.
1 assessment when participants are recruited
Participant's quality of life
Time Frame: 1 assessment when participants are recruited
SF-12 questionnaire: total score greater than 50 points, better quality of life
1 assessment when participants are recruited

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alcala

Investigators

  • Principal Investigator: Lara Díaz Álvarez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIM/2024/2/030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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