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Pelvic Floor Dysfunctions and Female Athletes (ACTITUD1)

Primary Purpose

Pelvic Floor Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Educational online session about PF
Sponsored by
University of the Balearic Islands
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pelvic Floor Disorders focused on measuring Female, Athlete, Track and Field, Education

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of the Balearic Islands

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Educational online session about PF

Control

Arm Description

Participants will attend an 90-minutes educational online session.

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.

Outcomes

Primary Outcome Measures

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).
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 31, 2023
Last Updated
April 19, 2023
Sponsor
University of the Balearic Islands
Collaborators
Fundació d'investigació Sanitària de les Illes Balears, Consejo Superior de Deportes
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1. Study Identification

Unique Protocol Identification Number
NCT05812170
Brief Title
Pelvic Floor Dysfunctions and Female Athletes
Acronym
ACTITUD1
Official Title
Awareness, Control and Treatment of Urinary Incontinence and Other Pelvic Floor Dysfunctions in Female Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of the Balearic Islands
Collaborators
Fundació d'investigació Sanitària de les Illes Balears, Consejo Superior de Deportes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders
Keywords
Female, Athlete, Track and Field, Education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A quasiexperimental controlled trial is designed, with two arms: an experimental group and a control group.
Masking
None (Open Label)
Masking Description
The design of this study does not allow to mask participants, care providers, investigators or outcomes assessors.
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Educational online session about PF
Arm Type
Experimental
Arm Description
Participants will attend an 90-minutes educational online session.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Educational online session about PF
Intervention 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).
Primary Outcome Measure Information:
Title
Knowledge about pelvic floor
Description
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).
Time Frame
One month
Title
Detrimental practices related to pelvic floor dysfunctions
Description
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.
Time Frame
One month
Title
Healthy practices to care pelvic floor
Description
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.
Time Frame
One month
Secondary Outcome Measure Information:
Title
Gender stereotypes
Description
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.
Time Frame
One month
Title
PFD auto-reported diagnosis
Description
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.
Time Frame
One month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia Romero-Franco, PhD
Phone
652632864
Email
natalia.romero@uib.es
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Carlos Fernández-Domínguez, PhD
Phone
971 25 95 13
Ext
9513
Email
jcarlos.fernandez@uib.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalia Romero-Franco, PhD
Organizational Affiliation
University of the Balearic Islands
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of the Balearic Islands
City
Palma De Mallorca
State/Province
Balearic Islands
ZIP/Postal Code
07122
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32774559
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.
Results Reference
result
PubMed Identifier
35704136
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. Sports Med Open. 2022 Jun 15;8(1):78. doi: 10.1186/s40798-022-00468-1.
Results Reference
result
PubMed Identifier
36053030
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: 10.1002/14651858.CD012337.pub2.
Results Reference
result
PubMed Identifier
26883864
Citation
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-0035-1571252. Epub 2016 Jan 29.
Results Reference
result

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Pelvic Floor Dysfunctions and Female Athletes

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