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NCT06455150 Clinical Trial

Prevalence of Pelvic Floor Dysfunctions in Female Badminton Athletes and Sedentary

Pelvic Floor Disorders Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06455150
Other study ID # CEIM/2024/2/030
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2024
Est. completion date February 2025

Study information
Verified date June 2024
Source University of Alcala
Contact Lara Díaz Álvarez
Phone +34 628849843
Email lara.diaza@edu.uah.es
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

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Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Spain Faculty of Nursing and Physiotherapy of the University of Alcala Alcalá De Henares Madrid

Sponsors (1)
Lead Sponsor Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

References & Publications (26)

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Outcome
Type Measure Description Time frame Safety issue
Primary Urinary incontinence symptoms 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
Primary Anal incontinence and pelvic organ prolapse symptoms 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
Primary Female sexual dysfunction symptoms 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 Stress urinary incontinence sign 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
Secondary Pelvic organ prolapse sign 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
Secondary Pelvic floor muscle strength 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
Secondary Participant's quality of life SF-12 questionnaire: total score greater than 50 points, better quality of life 1 assessment when participants are recruited
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Completed NCT05318768 - Association Between Physical Activity Level ，Overall Muscle Strength and Pelvic Floor Muscle Function in Women.
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