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
• Status: Not yet recruiting
• 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
• 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Floor Disorders

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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Campbell KG, Batt ME, Drummond A. Prevalence of pelvic floor dysfunction in recreational athletes: a cross-sectional survey. Int Urogynecol J. 2023 Oct;34(10):2429-2437. doi: 10.1007/s00192-023-05548-8. Epub 2023 May 10. — View Citation

Donnelly GM, Moore IS. Sports Medicine and the Pelvic Floor. Curr Sports Med Rep. 2023 Mar 1;22(3):82-90. doi: 10.1249/JSR.0000000000001045. — View Citation

Eickmeyer SM. Anatomy and Physiology of the Pelvic Floor. Phys Med Rehabil Clin N Am. 2017 Aug;28(3):455-460. doi: 10.1016/j.pmr.2017.03.003. Epub 2017 May 27. — View Citation

Espuna Pons M, Rebollo Alvarez P, Puig Clota M. [Validation of the Spanish version of the International Consultation on Incontinence Questionnaire-Short Form. A questionnaire for assessing the urinary incontinence]. Med Clin (Barc). 2004 Mar 6;122(8):288-92. doi: 10.1016/s0025-7753(04)74212-8. Spanish. — View Citation

Espuna-Pons M, Ros C, Ortega JA, Aliaga F, Perez-Gonzalez A, Palau MJ; Pelvic Floor Research Group (Grup de Recerca del Sol Pelvia, GRESP). Prevalence, incidence, and remission rates of urinary incontinence in women attended in gynecological practice. Neurourol Urodyn. 2017 Apr;36(4):1081-1085. doi: 10.1002/nau.23042. Epub 2016 Jun 6. — View Citation

Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7. — View Citation

Giagio S, Salvioli S, Pillastrini P, Innocenti T. Sport and pelvic floor dysfunction in male and female athletes: A scoping review. Neurourol Urodyn. 2021 Jan;40(1):55-64. doi: 10.1002/nau.24564. Epub 2020 Nov 2. — View Citation

Gonza´lez Hinojosa J, Zapico Gon~i A´. Diagnóstico me´dico y tratamientos me´dico y quiru´rgico de las disfunciones del suelo pe´lvico femenino. Fisioterapia del Suelo Pe´lvico. Manual para la prevencio´n y el tratamiento en la mujer, en el hombre y en la infancia. Madrid: Editorial Me´dica Panamericana; 2022. p. 109-25. ISBN: 978-84-9110-453-7.

Guralnick ML, Fritel X, Tarcan T, Espuna-Pons M, Rosier PFWM. ICS Educational Module: Cough stress test in the evaluation of female urinary incontinence: Introducing the ICS-Uniform Cough Stress Test. Neurourol Urodyn. 2018 Jun;37(5):1849-1855. doi: 10.1002/nau.23519. Epub 2018 Jun 21. — View Citation

Hall AF, Theofrastous JP, Cundiff GW, Harris RL, Hamilton LF, Swift SE, Bump RC. Interobserver and intraobserver reliability of the proposed International Continence Society, Society of Gynecologic Surgeons, and American Urogynecologic Society pelvic organ prolapse classification system. Am J Obstet Gynecol. 1996 Dec;175(6):1467-70; discussion 1470-1. doi: 10.1016/s0002-9378(96)70091-1. — View Citation

Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798. — View Citation

Haylen BT, Maher CF, Barber MD, Camargo S, Dandolu V, Digesu A, Goldman HB, Huser M, Milani AL, Moran PA, Schaer GN, Withagen MI. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic organ prolapse (POP). Int Urogynecol J. 2016 Apr;27(4):655-84. doi: 10.1007/s00192-016-3003-y. — View Citation

Navarro Brazalez B, Torres Lacomba M, de la Villa P, Sanchez Sanchez B, Prieto Gomez V, Asunsolo Del Barco A, McLean L. The evaluation of pelvic floor muscle strength in women with pelvic floor dysfunction: A reliability and correlation study. Neurourol Urodyn. 2018 Jan;37(1):269-277. doi: 10.1002/nau.23287. Epub 2017 Apr 28. — View Citation

Peinado Molina RA, Hernandez Martinez A, Martinez Vazquez S, Martinez Galiano JM. Influence of pelvic floor disorders on quality of life in women. Front Public Health. 2023 Oct 24;11:1180907. doi: 10.3389/fpubh.2023.1180907. eCollection 2023. — View Citation

Peinado-Molina RA, Hernandez-Martinez A, Martinez-Vazquez S, Rodriguez-Almagro J, Martinez-Galiano JM. Pelvic floor dysfunction: prevalence and associated factors. BMC Public Health. 2023 Oct 14;23(1):2005. doi: 10.1186/s12889-023-16901-3. — View Citation

Price DM, Noblett K. Comparison of the cough stress test and 24-h pad test in the assessment of stress urinary incontinence. Int Urogynecol J. 2012 Apr;23(4):429-33. doi: 10.1007/s00192-011-1602-1. Epub 2011 Nov 16. — View Citation

Sa´nchez Sa´nchez B. Epidemiología y factores de riesgo en las disfunciones del suelo pe´lvico. Fisioterapia del Suelo Pélvico. Manual para la prevención y el tratamiento en la mujer, en el hombre y en la infancia. Madrid: Editorial Médica Panamericana; 2022. p. 101-7. ISBN: 978-84-9110-453-7.

Sanchez-Sanchez B, Navarro-Brazalez B, Arranz-Martin B, Sanchez-Mendez O, de la Rosa-Diaz I, Torres-Lacomba M. The Female Sexual Function Index: Transculturally Adaptation and Psychometric Validation in Spanish Women. Int J Environ Res Public Health. 2020 Feb 5;17(3):994. doi: 10.3390/ijerph17030994. Erratum In: Int J Environ Res Public Health. 2020 Jun 17;17(12): — View Citation

Sanchez-Sanchez B, Torres-Lacomba M, Yuste-Sanchez MJ, Navarro-Brazalez B, Pacheco-da-Costa S, Gutierrez-Ortega C, Zapico-Goni A. Cultural adaptation and validation of the Pelvic Floor Distress Inventory short form (PFDI-20) and Pelvic Floor Impact Questionnaire short form (PFIQ-7) Spanish versions. Eur J Obstet Gynecol Reprod Biol. 2013 Sep;170(1):281-5. doi: 10.1016/j.ejogrb.2013.07.006. Epub 2013 Jul 25. — View Citation

Teixeira RV, Colla C, Sbruzzi G, Mallmann A, Paiva LL. Prevalence of urinary incontinence in female athletes: a systematic review with meta-analysis. Int Urogynecol J. 2018 Dec;29(12):1717-1725. doi: 10.1007/s00192-018-3651-1. Epub 2018 Apr 13. — View Citation

Tim S, Mazur-Bialy AI. The Most Common Functional Disorders and Factors Affecting Female Pelvic Floor. Life (Basel). 2021 Dec 14;11(12):1397. doi: 10.3390/life11121397. — View Citation

Torres Lacomba M, Navarro Brazález B, Arranz Martín B. Fisioterapia y suelo pélvico: condiciones específicas en la vida de la mujer. Fisioterapia del Suelo Pélvico. Manual para la prevención y el tratamiento en la mujer, en el hombre y en la infancia. Madrid: Editorial Médica Panamericana; 2022. p. 145-60. ISBN: 978-84-9110-453-7.

Vilagut G, Valderas JM, Ferrer M, Garin O, Lopez-Garcia E, Alonso J. [Interpretation of SF-36 and SF-12 questionnaires in Spain: physical and mental components]. Med Clin (Barc). 2008 May 24;130(19):726-35. doi: 10.1157/13121076. Spanish. — View Citation

von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9. doi: 10.1016/j.jclinepi.2007.11.008. — View Citation

Wiegel M, Meston C, Rosen R. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther. 2005 Jan-Feb;31(1):1-20. doi: 10.1080/00926230590475206. — View Citation

* Note: There are 26 references in all — Click here to view all references

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

External Links

•   Epidat: epidemiological data analysis' program
•   Spanish Association of Urology. Questionnaires
•   World Health Organization. Physical Activity