Pelvic FloorNCT05356832
Investigation of the Relationship Between Pelvic Floor Awareness and Urinary Incontinence
An observational study of Pelvic Floor and Urinary Incontinence, run by Pinar Yasar at 1 site in Turkey (Türkiye).
Trial summary
There is no study in the literature examining the knowledge level and urinary symptoms of active athletes about the pelvic floor. The aim of this study is to determine the relationship between PTC awareness and incontinence in young athletes who engage in long-term and high-intensity activities that increase the risk… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor, Urinary Incontinence, Young Athletes
- What is being tested?
- Pelvic Floor Health Knowledge Quiz
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to Jul 2022
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young athletes studying at Süleyman Demirel University, Faculty of Sport Sciences
Who may be able to join
- 18-25 years old Young athletes
Who cannot join
- Having a neurological disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Suleyman Demirel University
Isparta, 32100
About this study
Official title: Investigation of the Relationship Between Pelvic Floor Awareness and Urinary Incontinence in Young Athletes
There is no study in the literature examining the knowledge level and urinary symptoms of active athletes about the pelvic floor. The aim of this study is to determine the relationship between PTC awareness and incontinence in young athletes who engage in long-term and high-intensity activities that increase the risk of SUI.
- Conditions
- Pelvic Floor, Urinary Incontinence, Young Athletes
- Being tested
- Pelvic Floor Health Knowledge Quiz
- Keywords
- pelvic floor, awareness, knowledge, urinary incontinence, athletes
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Health Knowledge QuizDiagnostic test
Also called International Physical Activity Questionnaire-Short Form, International Consultation on Incontinence Questionnaire-Short Form, Incontinence Impact Questionnaire-7
It is a questionnaire to measure the knowledge level of the participants about pelvic floor health.
| Study group | Role | What they receive |
|---|---|---|
| continent | able to hold urine during sports Receives: Diagnostic Test: Pelvic Floor Health Knowledge Quiz | |
| incontinent | leaking urine during sports Receives: Diagnostic Test: Pelvic Floor Health Knowledge Quiz |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire- Short Form
The physical activity level is determined by recording the light, moderate and vigorous activities and sitting time of the person in the last 1 week.
Measured: baseline
Pelvic Floor Health Knowledge Quiz
It is a questionnaire to measure the knowledge level of the participants about pelvic floor health.
Measured: baseline
International Urinary Incontinence Consultation Questionnaire-Short Form (ICIQ-SF)
It is a questionnaire containing six questions to find out the frequency of urinary incontinence, during which activities it occurs, and how much the person is affected by this condition.
Measured: baseline
Incontinence Impact Questionnaire-7
It is a questionnaire consisting of 7 questions used in the evaluation of daily life effects due to incontinence.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Jan 2022
- Primary completionMay 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pinar Yasar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pinar Yasar, Suleyman Demirel University
- Investigators
- Pinar YASAR, Study director, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356832
- Sponsor's protocol ID
- E 87432956-050.99-184902
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Pelvic Floor Awareness and Urinary Incontinence in Young Athletes
- ClinicalTrials.gov ID
- NCT05356832
- Acronym / sponsor ID
- E 87432956-050.99-184902
- Conditions
- Pelvic Floor, Urinary Incontinence, Young Athletes
- Keywords
- pelvic floor, awareness, knowledge, urinary incontinence, athletes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Pinar YasarUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 2 May 2022 (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.
There is no study in the literature examining the knowledge level and urinary symptoms of active athletes about the pelvic floor. The aim of this study is to determine the relationship between PTC awareness and incontinence in young athletes who engage in long-term and high-intensity activities that increase the risk of SUI.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continent | – | Diagnostic Test: Pelvic Floor Health Knowledge Quizable to hold urine during sports |
| incontinent | – | Diagnostic Test: Pelvic Floor Health Knowledge Quizleaking urine during sports |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young athletes studying at Süleyman Demirel University, Faculty of Sport Sciences
Key inclusion criteria (1 listed)
- 18-25 years old Young athletes
Key exclusion criteria (1 listed)
- Having a neurological disorders
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 |
|---|---|---|
| Pelvic Floor Health Knowledge QuizAlso: International Physical Activity Questionnaire-Short Form, International Consultation on Incontinence Questionnaire-Short Form, Incontinence Impact Questionnaire-7It is a questionnaire to measure the knowledge level of the participants about pelvic floor health. | Diagnostic test | continent, incontinent |
Primary outcome
International Physical Activity Questionnaire- Short Form
Time frame: baseline
The physical activity level is determined by recording the light, moderate and vigorous activities and sitting time of the person in the last 1 week.
Pelvic Floor Health Knowledge Quiz
Time frame: baseline
It is a questionnaire to measure the knowledge level of the participants about pelvic floor health.
International Urinary Incontinence Consultation Questionnaire-Short Form (ICIQ-SF)
Time frame: baseline
It is a questionnaire containing six questions to find out the frequency of urinary incontinence, during which activities it occurs, and how much the person is affected by this condition.
Incontinence Impact Questionnaire-7
Time frame: baseline
It is a questionnaire consisting of 7 questions used in the evaluation of daily life effects due to incontinence.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
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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.
Pinar YASAR study director
Suleyman Demirel University
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 Urinary Incontinence, run by Pinar Yasar 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 1 inclusion and 1 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 2 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pinar YASAR, MsC (+90535 014 53 40, pinarergoz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Physical Activity Questionnaire- Short Form (time frame: baseline). 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?
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 2 May 2022.