Pelvic Floor DisordersNCT06455150
Prevalence of Pelvic Floor Dysfunctions in Female Badminton Athletes and Sedentary
An observational study of Pelvic Floor Disorders, run by University of Alcala at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Assessment of pelvic floor dysfunctions' symptoms and sings, pelvic floor muscle strength and quality of life
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2024to Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Nursing and Physiotherapy of the University of Alcala
Alcalá de Henares, Madrid, 28805
Lara Díaz Álvarez, +34 628849843, lara.diaza@edu.uah.es
Lara Díaz Álvarez
About this study
Official title: 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.
Read the 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.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Assessment of pelvic floor dysfunctions' symptoms and sings, pelvic floor muscle strength and quality of life
- Keywords
- prevalence, pelvic floor disorders, racquet sports, sedentary behavior, women
- Medical subject headings
- Pelvic Floor Disorders, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of pelvic floor dysfunctions' symptoms and sings, pelvic floor muscle strength and quality of lifeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Female badminton athletes Receives: Other: Assessment of pelvic floor dysfunctions' symptoms and sings, pelvic floor muscle strength and quality of life | |
| Controls | Sedentary women Receives: Other: Assessment of pelvic floor dysfunctions' symptoms and sings, pelvic floor muscle strength and quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary incontinence symptoms
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF): total score greater than 0 is positive for urinary incontinence
Measured: 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.
Measured: 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
Measured: 1 assessment when participants are recruited
Secondary outcomes (4)
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).
Measured: 1 assessment when participants are recruited
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.
Measured: 1 assessment when participants are recruited
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.
Measured: 1 assessment when participants are recruited
Participant's quality of life
SF-12 questionnaire: total score greater than 50 points, better quality of life
Measured: 1 assessment when participants are recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study startSep 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Díaz Álvarez, University of Alcala
- Investigators
- Lara Díaz Álvarez, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455150
- Sponsor's protocol ID
- CEIM/2024/2/030
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28676358Donnelly 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.
PubMed 36866951Torres 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.
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.
PubMed 12547746Giagio 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.
PubMed 33137211von 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.
PubMed 18313558Peinado-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.
PubMed 37838661Teixeira 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.
PubMed 29654349Sánchez 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.
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.
PubMed 34947928Espuna 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.
PubMed 15030739Sanchez-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.
PubMed 23891390Haylen 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.
PubMed 19941278Sanchez-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.
PubMed 32033334Wiegel 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.
PubMed 15841702
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Pelvic Floor Dysfunctions in Female Badminton Athletes and Sedentary: Protocol of an Observational Case-Control Study
- ClinicalTrials.gov ID
- NCT06455150
- Acronym / sponsor ID
- CEIM/2024/2/030
- Conditions
- Pelvic Floor Disorders
- Keywords
- prevalence, pelvic floor disorders, racquet sports, sedentary behavior, women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Assessment of pelvic floor dysfunctions' symptoms and sings, pelvic floor muscle strength and quality of lifeFemale badminton athletes |
| Controls | – | Other: Assessment of pelvic floor dysfunctions' symptoms and sings, pelvic floor muscle strength and quality of lifeSedentary women |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of pelvic floor dysfunctions' symptoms and sings, pelvic floor muscle strength and quality of lifeIt 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. | Other | Cases, Controls |
Primary outcome
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
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.
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
4 secondary outcomes
Stress urinary incontinence sign
Time frame: 1 assessment when participants are recruited
Pelvic organ prolapse sign
Time frame: 1 assessment when participants are recruited
Pelvic floor muscle strength
Time frame: 1 assessment when participants are recruited
Participant's quality of life
Time frame: 1 assessment when participants are recruited
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Background: PubMed 28676358Eickmeyer 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.
- Background: PubMed 36866951Donnelly 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.
- BackgroundTorres 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: PubMed 12547746Cabello 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.
- Background: PubMed 33137211Giagio 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.
- Background: PubMed 18313558von 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.
- Background: PubMed 37838661Peinado-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.
- Background: PubMed 29654349Teixeira 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.
- BackgroundSánchez 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: PubMed 34947928Tim 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.
- Background: PubMed 15030739Espuna 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.
- Background: PubMed 23891390Sanchez-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.
- World Health Organization. Physical ActivityLink provided by the sponsor.
- Epidat: epidemiological data analysis' programLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara Díaz Álvarez principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Disorders, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lara Díaz Álvarez (+34 628849843, lara.diaza@edu.uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary incontinence symptoms (time frame: 1 assessment when participants are recruited). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06455150, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.