NCT06455150

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

June 6, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

June 6, 2024

Last Update Submit

June 11, 2024

Conditions

Keywords

prevalencepelvic floor disordersracquet sportssedentary behaviorwomen

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

  • Stress urinary incontinence sign

    1 assessment when participants are recruited

  • Pelvic organ prolapse sign

    1 assessment when participants are recruited

  • Pelvic floor muscle strength

    1 assessment when participants are recruited

  • Participant's quality of life

    1 assessment when participants are recruited

Study Arms (2)

Cases

Female badminton athletes

Other: Assessment of pelvic floor dysfunctions' symptoms and sings, pelvic floor muscle strength and quality of life

Controls

Sedentary women

Other: Assessment of pelvic floor dysfunctions' symptoms and sings, pelvic floor muscle strength and quality of life

Interventions

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.

CasesControls

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing and Physiotherapy of the University of Alcala

Alcalá de Henares, Madrid, 28805, Spain

Location

Related Publications (26)

  • 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.

    PMID: 28676358BACKGROUND
  • 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.

    PMID: 36866951BACKGROUND
  • 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.

    BACKGROUND
  • Cabello Manrique D, Gonzalez-Badillo JJ. Analysis of the characteristics of competitive badminton. Br J Sports Med. 2003 Feb;37(1):62-6. doi: 10.1136/bjsm.37.1.62.

    PMID: 12547746BACKGROUND
  • 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.

    PMID: 33137211BACKGROUND
  • 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.

    PMID: 18313558BACKGROUND
  • 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.

    PMID: 37838661BACKGROUND
  • 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.

    PMID: 29654349BACKGROUND
  • Sánchez Sánchez B. Epidemiología y factores de riesgo en las disfunciones del suelo pélvico. 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.

    BACKGROUND
  • 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.

    PMID: 34947928BACKGROUND
  • 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.

    PMID: 15030739BACKGROUND
  • 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.

    PMID: 23891390BACKGROUND
  • 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.

    PMID: 19941278BACKGROUND
  • 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.

    PMID: 32033334BACKGROUND
  • 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.

    PMID: 15841702BACKGROUND
  • 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.

    PMID: 22086265BACKGROUND
  • 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.

    PMID: 29926966BACKGROUND
  • 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.

    PMID: 26984443BACKGROUND
  • González Hinojosa J, Zapico Goñi Á. Diagnóstico médico y tratamientos médico y quirúrgico de las disfunciones del suelo pélvico femenino. 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. 109-25. ISBN: 978-84-9110-453-7.

    BACKGROUND
  • 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.

    PMID: 8987926BACKGROUND
  • 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.

    PMID: 28455942BACKGROUND
  • 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.

    PMID: 9817135BACKGROUND
  • 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.

    PMID: 18570798BACKGROUND
  • 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.

    PMID: 37942254BACKGROUND
  • 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.

    PMID: 37162534BACKGROUND
  • 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.

    PMID: 27272064BACKGROUND

Related Links

MeSH Terms

Conditions

Pelvic Floor DisordersSedentary Behavior

Interventions

SingingQuality of Life

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital DiseasesBehavior

Intervention Hierarchy (Ancestors)

PhonationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Lara Díaz Álvarez

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lara Díaz Álvarez

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

June 6, 2024

First Posted

June 12, 2024

Study Start

September 1, 2024

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

June 12, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations