Pelvic Floor DisordersACTITUDNCT06355297
Educational Intervention Related to Pelvic Floor Care in Females in Sport: ACTITUD
A study testing Education about pelvic floor in people with Pelvic Floor Disorders, run by University of the Balearic Islands at 1 site in Spain.
Trial summary
Pelvic floor dysfunctions (PFD) are especially prevalent among females who practice and compete in sport. One of the main reason is the great physical effort required to achieve the maximal sports performance. As conservational management, increasing the females' information is an important research line. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Education about pelvic floor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- 9 Apr 2024to 20 Jun 2024
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- To train and compete in any of the sport modality.
- To have federative license from a regional or national sport federation in the season when study starts.
Who cannot join
- Non applicable
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of the Balearic Islands
Palma de Mallorca, Balearic Islands, 07122
About this study
Official title: Educational Intervention Related to Pelvic Floor Care in Females in Sport
Pelvic floor dysfunctions (PFD) are especially prevalent among females who practice and compete in sport. One of the main reason is the great physical effort required to achieve the maximal sports performance. As conservational management, increasing the females' information is an important research line. However, gender stereotypes, embarrassment and normalization among females make it difficult to seek professional care. In this situation, prevention or management of PFD is limited.
New technologies could facilitate engaging virtual educational approaches. This study will evaluate the effects of an educational intervention compounded by three sessions (60 min of duration) with one week apart, about PFD, habits related with it, and existing gender stereotypes.
To this end, all female who practice and compete in any sport in Spain will be invited to attend an educational online intervention with theoretical-practical content about PFD. As eligibility criteria, participants should train and compete in any sport, and have federative license from regional or national sports federation at the moment of the start of the study. Participants should have at least 16 years old. The investigators expect 400 athletes to fulfill the questionnaires, of which the investigators expect 200 to attend the educational intervention. Before the educational intervention, all females will reply an anonymous questionnaire to inform about their knowledge of PFD, daily practices related to PFD, influencing gender stereotypes and PFD self-reported diagnosis. One month later, this questionnaire will be sent to females (both athletes who attended the educational intervention or not) to describe changes after attending the online educational intervention and compared to those females who did not attend it. The main outcomes will be the level of knowledge about PF, the number of habits potentially related to PFD, and score of gender stereotyped beliefs. As an additional outcome, it will be considered the PFD self-reported symptomatology.
Read the detailed description
The educational intervention consisted on three 60-minutes online sessions, organized as follows:
Session 1: anatomical information about pelvic floor and exercises about pelvic floor consciousness; Session 2: function and dysfunction of pelvic floor and exercises related; Session 3: risk factor for pelvic floor dysfunctions and exercises to strengthen the pelvic floor musculature.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Education about pelvic floor
- Keywords
- Female, Sport, Education
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education about pelvic floorBehavioural
The three educational sessions will last 60 minutes, as follows: session1, anatomy of pelvic floor; session2, function and dysfunction of pelvic floor; session3, risk factor for pelvic floor dysfunctions.
| Study group | Role | What they receive |
|---|---|---|
| Education about PF | Experimental | Education about PF. Participants will attend three 60-minutes educational online sessions. Receives: Behavioral: Education about pelvic floor |
| Control | No intervention | Despite the fact that all females will be invited to participate in the study, those who did not attend the educational sessions will be considered as control group. These participants will not receive any educational session or information about PF prior to be evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge about pelvic floor
Change in the level of knowledge about pelvic floor according to the responses to an online questionnaire after attending the online educational sessions and compared to those females who do not attend educational sessions. To assess it, participants will reply an ad-hoc questionnaire with ten multiple-choice questions about pelvic floor structures. It will be counted the number of correct answers (0 points as the worst punctuation, 10 points as the best punctuation).
Measured: One month
Habits related to pelvic floor dysfunctions
Change in number of habits that participants often carry out during their daily life, potentially related to pelvic floor dysfunctions, after attending the online educational sessions and compared to those athletes who do not attend educational sessions.
Measured: One month
Secondary outcomes (2)
Gender stereotypes beliefs
Change in the score related to gender stereotypes beliefs, after attending the online educational sessions and compared to those females who do not attend educational sessions. This score will be obtained after the sum of the factor1 and factor3 from the validated questionnaire CEGAFD (in English: beliefs and gender-based stereotypes concerning physical activity and sport). For the factor1 and factor3, females will rate from 1(completely disagree) to 4 (completely agree) to 7 and 5 gender stereotypes statements, respectively. The sum of the two factors will be the score of gender stereotypes beliefs (from 12 points as minimal gender stereotypes beliefs - 7 points for factor1 and 5 points for factor3 -, to 48 points as the maximal gender stereotypes beliefs - 28 points for factor1 and 20 points for factor3).
Measured: One month
Occurrence of symptoms related to pelvic floor dysfunctions
It will be considered if pelvic floor dysfunction is self-reported through the questionnaire that athletes will reply. To this end, athletes will reply five yes-no questions regarding the occurrence of the main symptoms related to pelvic floor dysfunctions. In case of affirmative response in any of these diagnostic questions, it will be considered that this athlete has the symptom related to pelvic floor dysfunction. Between-group differences were considered.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start9 Apr 2024
- Primary completion22 May 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A quasiexperimental controlled trial is designed, with two arms: an experimental group and a control group.
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalia Romero-Franco, PhD, Principal investigator, University of the Balearic Islands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355297
- Sponsor's protocol ID
- 124CER19.
- Acronym
- ACTITUD
- Status last verified
- Jul 2024
- First submitted
- 31 Mar 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goodridge SD, Chisholm LP, Heft J, Hartigan S, Kaufman M, Dmochowski RR, Stewart T, Reynolds WS. Association of Knowledge and Presence of Pelvic Floor Disorders and Participation in Pelvic Floor Exercises: A Cross-sectional Study. Female Pelvic Med Reconstr Surg. 2021 May 1;27(5):310-314. doi: 10.1097/SPV.0000000000000813.
PubMed 32217913Rashidi Fakari F, Hajian S, Darvish S, Alavi Majd H. Explaining factors affecting help-seeking behaviors in women with urinary incontinence: a qualitative study. BMC Health Serv Res. 2021 Jan 13;21(1):60. doi: 10.1186/s12913-020-06047-y.
PubMed 33435931Elenskaia K, Haidvogel K, Heidinger C, Doerfler D, Umek W, Hanzal E. The greatest taboo: urinary incontinence as a source of shame and embarrassment. Wien Klin Wochenschr. 2011 Oct;123(19-20):607-10. doi: 10.1007/s00508-011-0013-0. Epub 2011 Sep 22.
PubMed 21935649Reynolds WS, Kowalik C, Delpe SD, Kaufman M, Fowke JH, Dmochowski R. Toileting Behaviors and Bladder Symptoms in Women Who Limit Restroom Use at Work: A Cross-Sectional Study. J Urol. 2019 Nov;202(5):1008-1014. doi: 10.1097/JU.0000000000000315. Epub 2019 Oct 9.
PubMed 31059664
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Intervention Related to Pelvic Floor Care in Females in Sport
- ClinicalTrials.gov ID
- NCT06355297
- Acronym / sponsor ID
- ACTITUD / 124CER19.
- Conditions
- Pelvic Floor Disorders
- Keywords
- Female, Sport, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 9 Apr 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.
Pelvic floor dysfunctions (PFD) are especially prevalent among females who practice and compete in sport. One of the main reason is the great physical effort required to achieve the maximal sports performance. As conservational management, increasing the females' information is an important research line. However, gender stereotypes, embarrassment and normalization among females make it difficult to seek professional care. In this situation, prevention or management of PFD is limited.
New technologies could facilitate engaging virtual educational approaches. This study will evaluate the effects of an educational intervention compounded by three sessions (60 min of duration) with one week apart, about PFD, habits related with it, and existing gender stereotypes.
To this end, all female who practice and compete in any sport in Spain will be invited to attend an educational online intervention with theoretical-practical content about PFD. As eligibility criteria, participants should train and compete in any sport, and have federative license from regional or national sports federation at the moment of the start of the study. Participants should have at least 16 years old. The investigators expect 400 athletes to fulfill the questionnaires, of which the investigators expect 200 to attend the educational intervention. Before the educational intervention, all females will reply an anonymous questionnaire to inform about their knowledge of PFD, daily practices related to PFD, influencing gender stereotypes and PFD self-reported diagnosis. One month later, this questionnaire will be sent to females (both athletes who attended the educational intervention or not) to describe changes after attending the online educational intervention and compared to those females who did not attend it. The main outcomes will be the level of knowledge about PF, the number of habits potentially related to PFD, and score of gender stereotyped beliefs. As an additional outcome, it will be considered the PFD self-reported symptomatology.
Detailed description
The educational intervention consisted on three 60-minutes online sessions, organized as follows:
Session 1: anatomical information about pelvic floor and exercises about pelvic floor consciousness; Session 2: function and dysfunction of pelvic floor and exercises related; Session 3: risk factor for pelvic floor dysfunctions and exercises to strengthen the pelvic floor musculature.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A quasiexperimental controlled trial is designed, with two arms: an experimental group and a control group.
| Arm | Type | Receives |
|---|---|---|
| Education about PF | Experimental | Behavioral: Education about pelvic floorEducation about PF. Participants will attend three 60-minutes educational online sessions. |
| Control | No intervention | –Despite the fact that all females will be invited to participate in the study, those who did not attend the educational sessions will be considered as control group. These participants will not receive any educational session or information about PF prior to be evaluated. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- To train and compete in any of the sport modality.
- To have federative license from a regional or national sport federation in the season when study starts.
Key exclusion criteria (1 listed)
- Non applicable
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 |
|---|---|---|
| Education about pelvic floorThe three educational sessions will last 60 minutes, as follows: session1, anatomy of pelvic floor; session2, function and dysfunction of pelvic floor; session3, risk factor for pelvic floor dysfunctions. | Behavioural | Education about PF |
Primary outcome
Knowledge about pelvic floor
Time frame: One month
Change in the level of knowledge about pelvic floor according to the responses to an online questionnaire after attending the online educational sessions and compared to those females who do not attend educational sessions. To assess it, participants will reply an ad-hoc questionnaire with ten multiple-choice questions about pelvic floor structures. It will be counted the number of correct answers (0 points as the worst punctuation, 10 points as the best punctuation).
Habits related to pelvic floor dysfunctions
Time frame: One month
Change in number of habits that participants often carry out during their daily life, potentially related to pelvic floor dysfunctions, after attending the online educational sessions and compared to those athletes who do not attend educational sessions.
2 secondary outcomes
Gender stereotypes beliefs
Time frame: One month
Occurrence of symptoms related to pelvic floor dysfunctions
Time frame: One month
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 15 Oct 2024.
- Results publication: PubMed 32217913Goodridge SD, Chisholm LP, Heft J, Hartigan S, Kaufman M, Dmochowski RR, Stewart T, Reynolds WS. Association of Knowledge and Presence of Pelvic Floor Disorders and Participation in Pelvic Floor Exercises: A Cross-sectional Study. Female Pelvic Med Reconstr Surg. 2021 May 1;27(5):310-314. doi: 10.1097/SPV.0000000000000813.
- Results publication: PubMed 33435931Rashidi Fakari F, Hajian S, Darvish S, Alavi Majd H. Explaining factors affecting help-seeking behaviors in women with urinary incontinence: a qualitative study. BMC Health Serv Res. 2021 Jan 13;21(1):60. doi: 10.1186/s12913-020-06047-y.
- Results publication: PubMed 21935649Elenskaia K, Haidvogel K, Heidinger C, Doerfler D, Umek W, Hanzal E. The greatest taboo: urinary incontinence as a source of shame and embarrassment. Wien Klin Wochenschr. 2011 Oct;123(19-20):607-10. doi: 10.1007/s00508-011-0013-0. Epub 2011 Sep 22.
- Results publication: PubMed 31059664Reynolds WS, Kowalik C, Delpe SD, Kaufman M, Fowke JH, Dmochowski R. Toileting Behaviors and Bladder Symptoms in Women Who Limit Restroom Use at Work: A Cross-Sectional Study. J Urol. 2019 Nov;202(5):1008-1014. doi: 10.1097/JU.0000000000000315. Epub 2019 Oct 9.
- 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.
Natalia Romero-Franco, PhD principal investigator
University of the Balearic Islands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education about pelvic floor in people with Pelvic Floor Disorders, run by University of the Balearic Islands 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 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: finished, as of the sponsor's last update on 15 Oct 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?
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?
Knowledge about pelvic floor (time frame: One month). The study lists 2 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 NCT06355297, which also lists 4 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 15 Oct 2024.