Pelvic Floor Dysfunctions and Female Athletes

Pelvic Floor Disorders Clinical Trial

— ACTITUD1  

Official title:

Awareness, Control and Treatment of Urinary Incontinence and Other Pelvic Floor Dysfunctions in Female Athletes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05812170
• Other study ID #: 124CER19
• Status: Completed
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: July 20, 2023

Study information

• Verified date: March 2024
• Source: University of the Balearic Islands
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: July 20, 2023
• Est. primary completion date: June 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Non-applicable

Related Conditions & MeSH terms

• Pelvic Floor Disorders

Intervention

Behavioral:
• Educational online session about PF
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).

Locations

Country	Name	City	State
Spain	University of the Balearic Islands	Palma De Mallorca	Balearic Islands

Sponsors (3)

Lead Sponsor	Collaborator
University of the Balearic Islands	Consejo Superior de Deportes, Fundació d'investigació Sanitària de les Illes Balears

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Moroni RM, Magnani PS, Haddad JM, Castro Rde A, Brito LG. Conservative Treatment of Stress Urinary Incontinence: A Systematic Review with Meta-analysis of Randomized Controlled Trials. Rev Bras Ginecol Obstet. 2016 Feb;38(2):97-111. doi: 10.1055/s-0035-15 — View Citation

Pires T, Pires P, Moreira H, Viana R. Prevalence of Urinary Incontinence in High-Impact Sport Athletes: A Systematic Review and Meta-Analysis. J Hum Kinet. 2020 Jul 21;73:279-288. doi: 10.2478/hukin-2020-0008. eCollection 2020 Jul. — View Citation

Rodriguez-Lopez ES, Acevedo-Gomez MB, Romero-Franco N, Basas-Garcia A, Ramirez-Parenteau C, Calvo-Moreno SO, Fernandez-Dominguez JC. Urinary Incontinence Among Elite Track and Field Athletes According to Their Event Specialization: A Cross-Sectional Study — View Citation

Todhunter-Brown A, Hazelton C, Campbell P, Elders A, Hagen S, McClurg D. Conservative interventions for treating urinary incontinence in women: an Overview of Cochrane systematic reviews. Cochrane Database Syst Rev. 2022 Sep 2;9(9):CD012337. doi: 10.1002/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	One month
Primary	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.	One month
Primary	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.	One month
Secondary	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.	One month
Secondary	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.	One month