Pelvic FloorNCT07209839
Pelvic Floor Knowledge and Dysfunction in Female Athletes
An observational study of Pelvic Floor and Female Athletes, run by Berivan Beril Kılıç at 1 site in Turkey (Türkiye).
Trial summary
The pelvic floor is a complex structure composed of bones, connective tissue, muscles, and nerves that supports the pelvic organs and provides voluntary control and resting tone of the sphincters. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor, Female Athletes, Physical Activity
- How many people
- 127 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Oct 2025to 10 Nov 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 16 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: female athletes who volunteered to participate
Who may be able to join
- Women aged 16-40 years who are literate
- Engaged in any sport, training at least 1 hour per session, at least 3 days per week
Who cannot join
- Having cooperation problems preventing completion of the questionnaires
- History of neurological disease
- History of urogynecological surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Faculy of Medicine-Department of Sports Medicine
Fatih, Istanbul
About this study
Official title: Pelvic Floor Knowledge and Dysfunctions in Female Athletes: Associations With Physical Activity, Demographic Characteristics, and Sports Profile
The pelvic floor is a complex structure composed of bones, connective tissue, muscles, and nerves that supports the pelvic organs and provides voluntary control and resting tone of the sphincters. Closely related to continence, sexual function, core stabilization, and posture, the pelvic floor muscles-particularly the levator ani with its type 1 and type 2 fibers-ensure both resting tone and rapid responses to sudden increases in intra-abdominal pressure. In women, pelvic floor dysfunctions (including urinary and anal incontinence, pelvic organ prolapse, defecatory and sexual dysfunctions) occur especially during pregnancy, childbirth, and menopause and adversely affect quality of life. Recently, research on pelvic floor muscles and dysfunctions in female athletes has grown, with competing hypotheses suggesting that these muscles may be strong yet overloaded and weakened due to excessive training. Sports that increase intra-abdominal pressure, such as running, weightlifting, and gymnastics, may stress the pelvic floor and elevate dysfunction risk. Various studies have shown high prevalences of urinary and anal incontinence and pelvic organ prolapse in athletes, alongside generally low pelvic floor awareness. However, few studies have examined the relationship between physical activity level, type, and duration with pelvic floor dysfunction and awareness together. The present study aims to investigate the effects of physical activity, demographic characteristics, and sporting experience on pelvic floor dysfunctions and pelvic floor knowledge in female athletes.
- Conditions
- Pelvic Floor, Female Athletes, Physical Activity, Demographic Data
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| female athletes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic Information Assessment
Participants included in the study will be asked about their age, height, weight, education level, type of sport, years of sporting experience, and history of surgery and illness. They will then be asked to respond to questions, based on a diagram created by the researchers, regarding the location of the pelvic floor, the functions of the pelvic floor muscles, and whether they have experienced pelvic floor-related problems during training. All information will be recorded in the patient tracking form.
Measured: enrollment
Pelvic Floor Health Knowledge Level
Participants' knowledge of pelvic floor health will be assessed using the Pelvic Floor Health Knowledge Test developed by Al-Deges (2019), which aims to measure individuals' knowledge regarding pelvic floor problems. This questionnaire consists of 29 items designed to evaluate knowledge of pelvic floor function and dysfunction. Items 1-8 address pelvic floor function and dysfunction, items 9-21 cover risk factors and etiology, and items 22-29 pertain to diagnosis and treatment. Participants will be asked to answer each item by selecting "yes," "no," or "don't know." The validity and reliability of the questionnaire have been supported by previous studies.
Measured: enrollment
Pelvic Floor Dysfunction
Participants' pelvic floor dysfunctions will be assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20). This scale is designed to evaluate all symptoms related to pelvic floor disorders and the severity of the distress they cause. The PFDI-20 consists of 20 items across three subscales, with responses scored from 0 (not at all) to 4 (quite a bit). Subscale scores are calculated by averaging the responses for each subscale and multiplying by 25, resulting in a score range of 0 to 100 per subscale, and a total score ranging from 0 to 300. The Turkish validity and reliability of the scale were established by Çelenay et al. (2012).
Measured: enrollment
Physical Activity Level
Participants' physical activity levels will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). The IPAQ-SF is a widely used, self-reported, valid, and reliable tool designed to determine individuals' physical activity levels over the past seven days. The questionnaire consists of seven items and evaluates walking, moderate, and vigorous physical activities, as well as daily sitting time. It aims to determine the duration and frequency of these activities during the week. Data will be converted into MET (Metabolic Equivalent - MET minutes/week) values for analysis. Based on the total MET score, participants' physical activity levels will be classified as low, moderate, or high. The validity and reliability of the Turkish version of the IPAQ-SF have been established by Sağlam et al. (2010).
Measured: enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start3 Oct 2025
- Primary completion27 Oct 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Pelvic FloorStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berivan Beril Kılıç
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Berivan Beril Kılıç, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209839
- Sponsor's protocol ID
- 4
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Verbeek M, Hayward L. Pelvic Floor Dysfunction And Its Effect On Quality Of Sexual Life. Sex Med Rev. 2019 Oct;7(4):559-564. doi: 10.1016/j.sxmr.2019.05.007. Epub 2019 Jul 24.
PubMed 31351916Sun C, Hull T, Ozuner G. Risk factors and clinical characteristics of rectal prolapse in young patients. J Visc Surg. 2014 Dec;151(6):425-9. doi: 10.1016/j.jviscsurg.2014.07.013. Epub 2014 Sep 18.
PubMed 25242503Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.
PubMed 21058606Magor J, Martin R, Bird ML. Athletes' Knowledge of Pelvic Floor Dysfunction and Their Knowledge of and Engagement with Pelvic Floor Muscle Training: A Scoping Review. Int J Environ Res Public Health. 2025 Jan 14;22(1):104. doi: 10.3390/ijerph22010104.
PubMed 39857557Machin SE, Mukhopadhyay S. Pelvic organ prolapse: review of the aetiology, presentation, diagnosis and management. Menopause Int. 2011 Dec;17(4):132-6. doi: 10.1258/mi.2011.011108. Epub 2011 Nov 25.
PubMed 22120945Lakhoo J, Khatri G, Elsayed RF, Chernyak V, Olpin J, Steiner A, Tammisetti VS, Sundaram KM, Arora SS. MRI of the Male Pelvic Floor. Radiographics. 2019 Nov-Dec;39(7):2003-2022. doi: 10.1148/rg.2019190064.
PubMed 31697623Lai HH, Hsu EI, Teh BS, Butler EB, Boone TB. 13 years of experience with artificial urinary sphincter implantation at Baylor College of Medicine. J Urol. 2007 Mar;177(3):1021-5. doi: 10.1016/j.juro.2006.10.062.
PubMed 17296403High R, Thai K, Virani H, Kuehl T, Danford J. Prevalence of Pelvic Floor Disorders in Female CrossFit Athletes. Female Pelvic Med Reconstr Surg. 2020 Aug;26(8):498-502. doi: 10.1097/SPV.0000000000000776.
PubMed 31498240Haylen 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 Feb;27(2):165-94. doi: 10.1007/s00192-015-2932-1.
PubMed 26755051Haylen 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 19941278Giagio 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 33137211Donnelly 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 36866951Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Toprak Celenay S, Akbayrak T, Kaya S, Ekici G, Beksac S. Validity and reliability of the Turkish version of the Pelvic Floor Distress Inventory-20. Int Urogynecol J. 2012 Aug;23(8):1123-7. doi: 10.1007/s00192-012-1729-8. Epub 2012 Mar 29.
PubMed 22456806Casey EK, Temme K. Pelvic floor muscle function and urinary incontinence in the female athlete. Phys Sportsmed. 2017 Nov;45(4):399-407. doi: 10.1080/00913847.2017.1372677. Epub 2017 Sep 5.
PubMed 28845723
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Knowledge and Dysfunctions in Female Athletes: Associations With Physical Activity, Demographic Characteristics, and Sports Profile
- ClinicalTrials.gov ID
- NCT07209839
- Acronym / sponsor ID
- 4
- Conditions
- Pelvic Floor, Female Athletes, Physical Activity, Demographic Data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Berivan Beril KılıçUniversity, hospital or other
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 7 Oct 2025 (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 pelvic floor is a complex structure composed of bones, connective tissue, muscles, and nerves that supports the pelvic organs and provides voluntary control and resting tone of the sphincters. Closely related to continence, sexual function, core stabilization, and posture, the pelvic floor muscles-particularly the levator ani with its type 1 and type 2 fibers-ensure both resting tone and rapid responses to sudden increases in intra-abdominal pressure. In women, pelvic floor dysfunctions (including urinary and anal incontinence, pelvic organ prolapse, defecatory and sexual dysfunctions) occur especially during pregnancy, childbirth, and menopause and adversely affect quality of life. Recently, research on pelvic floor muscles and dysfunctions in female athletes has grown, with competing hypotheses suggesting that these muscles may be strong yet overloaded and weakened due to excessive training. Sports that increase intra-abdominal pressure, such as running, weightlifting, and gymnastics, may stress the pelvic floor and elevate dysfunction risk. Various studies have shown high prevalences of urinary and anal incontinence and pelvic organ prolapse in athletes, alongside generally low pelvic floor awareness. However, few studies have examined the relationship between physical activity level, type, and duration with pelvic floor dysfunction and awareness together. The present study aims to investigate the effects of physical activity, demographic characteristics, and sporting experience on pelvic floor dysfunctions and pelvic floor knowledge in female athletes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| female athletes | – | – |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- female athletes who volunteered to participate
Key inclusion criteria (2 listed)
- Women aged 16-40 years who are literate
- Engaged in any sport, training at least 1 hour per session, at least 3 days per week
Key exclusion criteria (3 listed)
- Having cooperation problems preventing completion of the questionnaires
- History of neurological disease
- History of urogynecological surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic Information Assessment
Time frame: enrollment
Participants included in the study will be asked about their age, height, weight, education level, type of sport, years of sporting experience, and history of surgery and illness. They will then be asked to respond to questions, based on a diagram created by the researchers, regarding the location of the pelvic floor, the functions of the pelvic floor muscles, and whether they have experienced pelvic floor-related problems during training. All information will be recorded in the patient tracking form.
Pelvic Floor Health Knowledge Level
Time frame: enrollment
Participants' knowledge of pelvic floor health will be assessed using the Pelvic Floor Health Knowledge Test developed by Al-Deges (2019), which aims to measure individuals' knowledge regarding pelvic floor problems. This questionnaire consists of 29 items designed to evaluate knowledge of pelvic floor function and dysfunction. Items 1-8 address pelvic floor function and dysfunction, items 9-21 cover risk factors and etiology, and items 22-29 pertain to diagnosis and treatment. Participants will be asked to answer each item by selecting "yes," "no," or "don't know." The validity and reliability of the questionnaire have been supported by previous studies.
Pelvic Floor Dysfunction
Time frame: enrollment
Participants' pelvic floor dysfunctions will be assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20). This scale is designed to evaluate all symptoms related to pelvic floor disorders and the severity of the distress they cause. The PFDI-20 consists of 20 items across three subscales, with responses scored from 0 (not at all) to 4 (quite a bit). Subscale scores are calculated by averaging the responses for each subscale and multiplying by 25, resulting in a score range of 0 to 100 per subscale, and a total score ranging from 0 to 300. The Turkish validity and reliability of the scale were established by Çelenay et al. (2012).
Physical Activity Level
Time frame: enrollment
Participants' physical activity levels will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). The IPAQ-SF is a widely used, self-reported, valid, and reliable tool designed to determine individuals' physical activity levels over the past seven days. The questionnaire consists of seven items and evaluates walking, moderate, and vigorous physical activities, as well as daily sitting time. It aims to determine the duration and frequency of these activities during the week. Data will be converted into MET (Metabolic Equivalent - MET minutes/week) values for analysis. Based on the total MET score, participants' physical activity levels will be classified as low, moderate, or high. The validity and reliability of the Turkish version of the IPAQ-SF have been established by Sağlam et al. (2010).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Results publication: PubMed 31351916Verbeek M, Hayward L. Pelvic Floor Dysfunction And Its Effect On Quality Of Sexual Life. Sex Med Rev. 2019 Oct;7(4):559-564. doi: 10.1016/j.sxmr.2019.05.007. Epub 2019 Jul 24.
- Results publication: PubMed 25242503Sun C, Hull T, Ozuner G. Risk factors and clinical characteristics of rectal prolapse in young patients. J Visc Surg. 2014 Dec;151(6):425-9. doi: 10.1016/j.jviscsurg.2014.07.013. Epub 2014 Sep 18.
- Results publication: PubMed 21058606Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.
- Results publication: PubMed 39857557Magor J, Martin R, Bird ML. Athletes' Knowledge of Pelvic Floor Dysfunction and Their Knowledge of and Engagement with Pelvic Floor Muscle Training: A Scoping Review. Int J Environ Res Public Health. 2025 Jan 14;22(1):104. doi: 10.3390/ijerph22010104.
- Results publication: PubMed 22120945Machin SE, Mukhopadhyay S. Pelvic organ prolapse: review of the aetiology, presentation, diagnosis and management. Menopause Int. 2011 Dec;17(4):132-6. doi: 10.1258/mi.2011.011108. Epub 2011 Nov 25.
- Results publication: PubMed 31697623Lakhoo J, Khatri G, Elsayed RF, Chernyak V, Olpin J, Steiner A, Tammisetti VS, Sundaram KM, Arora SS. MRI of the Male Pelvic Floor. Radiographics. 2019 Nov-Dec;39(7):2003-2022. doi: 10.1148/rg.2019190064.
- Results publication: PubMed 17296403Lai HH, Hsu EI, Teh BS, Butler EB, Boone TB. 13 years of experience with artificial urinary sphincter implantation at Baylor College of Medicine. J Urol. 2007 Mar;177(3):1021-5. doi: 10.1016/j.juro.2006.10.062.
- Results publication: PubMed 31498240High R, Thai K, Virani H, Kuehl T, Danford J. Prevalence of Pelvic Floor Disorders in Female CrossFit Athletes. Female Pelvic Med Reconstr Surg. 2020 Aug;26(8):498-502. doi: 10.1097/SPV.0000000000000776.
- Results publication: PubMed 26755051Haylen 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 Feb;27(2):165-94. doi: 10.1007/s00192-015-2932-1.
- Results publication: PubMed 19941278Haylen 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.
- Results publication: 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.
- Results publication: 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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Female Athletes, run by Berivan Beril Kılıç at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 26 Nov 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic Information Assessment (time frame: enrollment). The study lists 4 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 NCT07209839, which also lists 19 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 26 Nov 2025.