Pelvic Floor DisordersACTITUD1NCT05812170
Pelvic Floor Dysfunctions and Female Athletes
A study testing Educational online session about PF 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 athletes due to the efforts from sports practice. As conservational management, increasing the athletes' information regard important research lines. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Educational online session about PF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2023to 20 Jul 2023
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- To train and compete in any of the Track and Field modalities
- To have federative license from regional or national Track and Field 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: Awareness, Control and Treatment of Urinary Incontinence and Other Pelvic Floor Dysfunctions in Female Athletes
Pelvic floor dysfunctions (PFD) are especially prevalent among females athletes due to the efforts from sports practice. As conservational management, increasing the athletes' information regard important research lines. However, embarrassment of female athletes limits educational or health demands and facilitate an invisible condition, potentially influenced by gender stereotypes. New technologies could facilitate engaging virtual educational approaches. This study will evaluate the effects of an educational online session about PFD in the knowledge about it, and practices related with it, existing gender stereotypes and PFD diagnosis of female athletes. To this end, all female athletes who practice Track and Field in Spain will be invited to attend an educational online session with theoretical-practical content about PF. As eligibility criteria, participants should train and compete in any of the Track and Field modalities, and have federative license from regional or national Track and Field Federation at the moment of the start of the study. Participants should have at least 18 years old. The investigators expect 400 athletes to fulfill the questionnaires, of which the investigators expect 200 to attend the educational online session.
Before the educational online session, all female athletes will reply an anonymous questionnaire to inform about their knowledge of PFD, daily practices related to PFD, influencing gender stereotypes and PFD auto-reported diagnosis. One month later, this questionnaire will be sent to female athletes (both athletes who attended the educational session or not) to describe changes after attending the online educational session and compared to those athletes who did not attend it. The main outcomes will be the level of knowledge about PF, the number of detrimental practices potentially related to PFD, the number of healthy practices to care PF and existence of influencing gender stereotypes. As an additional outcome, it will be considered the PFD auto-reported diagnosis.
Read the detailed description
The educational online session will last 90 minutes, as follows: 10 minutes of contextualization, 40 minutes of practical content about pelvic floor consciousness and 40 of theoretical content (anatomy and practices related to PFD). Also, a 3D realistic virtual model of pelvic floor structures will be used.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Educational online session about PF
- Keywords
- Female, Athlete, Track and Field, 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.
Educational online session about PFBehavioural
The educational online session will last 90 minutes, as follows: 10 minutes of contextualization, 40 minutes of practical content about pelvic floor consciousness and 40 of theoretical content (anatomy and practices related to PFD).
| Study group | Role | What they receive |
|---|---|---|
| Educational online session about PF | Experimental | Participants will attend an 90-minutes educational online session. Receives: Behavioral: Educational online session about PF |
| Control | No intervention | Despite the fact that all athletes will be invited to participate in the study, those who did not attend the educational session 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 PF according to the responses to online questionnaire after attending the online educational session and compared to those athletes who do not attend educational session. 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
Detrimental practices related to pelvic floor dysfunctions
Change in number of detrimental practices that participants often carry out during their daily life, potentially related to pelvic floor dysfunctions, after attending the online educational session and compared to those athletes who do not attend educational session.
Measured: One month
Healthy practices to care pelvic floor
Change in number of healthy practices to care pelvic floor that participants often carry out during their daily life, after attending the online educational session and compared to those athletes who do not attend educational session.
Measured: One month
Secondary outcomes (2)
Gender stereotypes
Change in number of existing gender stereotypes that potentially influence PFD, after attending the online educational session and compared to those athletes who do not attend educational session.
Measured: One month
PFD auto-reported diagnosis
It will be considered if PFD is auto-reported through the questionnaire that athletes will reply. To this end, athletes will reply five yes-no questions regarding the existence of PFD. In case of affirmative response in any of these diagnostic questions by an athlete, it will be considered that this athlete has a PFD. 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 posted13 Apr 2023
- Study start15 May 2023
- Primary completion5 Jun 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació d'investigació Sanitària de les Illes Balears, Consejo Superior de Deportes, Spain
- Responsible party
- Sponsor
- Investigators
- Natalia Romero-Franco, PhD, Principal investigator, University of the Balearic Islands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812170
- Sponsor's protocol ID
- 124CER19
- Acronym
- ACTITUD1
- Status last verified
- Mar 2024
- First submitted
- 31 Mar 2023
- 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
Vico-Moreno E, Fernandez-Dominguez JC, Romero-Franco N, Molina-Mula J, Gonzalez-Trujillo A, Bosch-Donate E. An online workshop to raise awareness of pelvic floor in track and field female athletes: a quasi-experimental study. Arch Gynecol Obstet. 2025 Mar;311(3):715-722. doi: 10.1007/s00404-024-07790-x. Epub 2024 Oct 25.
PubMed 39455464
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
- Awareness, Control and Treatment of Urinary Incontinence and Other Pelvic Floor Dysfunctions in Female Athletes
- ClinicalTrials.gov ID
- NCT05812170
- Acronym / sponsor ID
- ACTITUD1 / 124CER19
- Conditions
- Pelvic Floor Disorders
- Keywords
- Female, Athlete, Track and Field, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Collaborators
- Fundació d'investigació Sanitària de les Illes Balears, Consejo Superior de Deportes, Spain
- Study start
- 15 May 2023 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 13 Apr 2023 (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 athletes due to the efforts from sports practice. As conservational management, increasing the athletes' information regard important research lines. However, embarrassment of female athletes limits educational or health demands and facilitate an invisible condition, potentially influenced by gender stereotypes. New technologies could facilitate engaging virtual educational approaches. This study will evaluate the effects of an educational online session about PFD in the knowledge about it, and practices related with it, existing gender stereotypes and PFD diagnosis of female athletes. To this end, all female athletes who practice Track and Field in Spain will be invited to attend an educational online session with theoretical-practical content about PF. As eligibility criteria, participants should train and compete in any of the Track and Field modalities, and have federative license from regional or national Track and Field Federation at the moment of the start of the study. Participants should have at least 18 years old. The investigators expect 400 athletes to fulfill the questionnaires, of which the investigators expect 200 to attend the educational online session.
Before the educational online session, all female athletes will reply an anonymous questionnaire to inform about their knowledge of PFD, daily practices related to PFD, influencing gender stereotypes and PFD auto-reported diagnosis. One month later, this questionnaire will be sent to female athletes (both athletes who attended the educational session or not) to describe changes after attending the online educational session and compared to those athletes who did not attend it. The main outcomes will be the level of knowledge about PF, the number of detrimental practices potentially related to PFD, the number of healthy practices to care PF and existence of influencing gender stereotypes. As an additional outcome, it will be considered the PFD auto-reported diagnosis.
Detailed description
The educational online session will last 90 minutes, as follows: 10 minutes of contextualization, 40 minutes of practical content about pelvic floor consciousness and 40 of theoretical content (anatomy and practices related to PFD). Also, a 3D realistic virtual model of pelvic floor structures will be used.
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 |
|---|---|---|
| Educational online session about PF | Experimental | Behavioral: Educational online session about PFParticipants will attend an 90-minutes educational online session. |
| Control | No intervention | –Despite the fact that all athletes will be invited to participate in the study, those who did not attend the educational session 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
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- To train and compete in any of the Track and Field modalities
- To have federative license from regional or national Track and Field 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 |
|---|---|---|
| Educational online session about PFThe educational online session will last 90 minutes, as follows: 10 minutes of contextualization, 40 minutes of practical content about pelvic floor consciousness and 40 of theoretical content (anatomy and practices related to PFD). | Behavioural | Educational online session about PF |
Primary outcome
Knowledge about pelvic floor
Time frame: One month
Change in the level of knowledge about PF according to the responses to online questionnaire after attending the online educational session and compared to those athletes who do not attend educational session. 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).
Detrimental practices related to pelvic floor dysfunctions
Time frame: One month
Change in number of detrimental practices that participants often carry out during their daily life, potentially related to pelvic floor dysfunctions, after attending the online educational session and compared to those athletes who do not attend educational session.
Healthy practices to care pelvic floor
Time frame: One month
Change in number of healthy practices to care pelvic floor that participants often carry out during their daily life, after attending the online educational session and compared to those athletes who do not attend educational session.
2 secondary outcomes
Gender stereotypes
Time frame: One month
PFD auto-reported diagnosis
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.
- Derived from this study: PubMed 39455464Vico-Moreno E, Fernandez-Dominguez JC, Romero-Franco N, Molina-Mula J, Gonzalez-Trujillo A, Bosch-Donate E. An online workshop to raise awareness of pelvic floor in track and field female athletes: a quasi-experimental study. Arch Gynecol Obstet. 2025 Mar;311(3):715-722. doi: 10.1007/s00404-024-07790-x. Epub 2024 Oct 25.
- Individual participant dataSharing planned: No
Related trials for Pelvic Floor Disorders
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruitingObservational study
Clinical, Functional, and Therapeutic Characterization of Women With Urinary Incontinence and Analysis of Factors Associated With Treatment Response
Urinary Incontinence (UI)
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
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 Educational online session about PF 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 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 NCT05812170, which also lists 1 linked publication.
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.