NCT06355297

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

April 9, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

October 15, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

March 31, 2024

Last Update Submit

October 9, 2024

Conditions

Keywords

FemaleSportEducation

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

    One month

Secondary Outcomes (2)

  • Gender stereotypes beliefs

    One month

  • Occurrence of symptoms related to pelvic floor dysfunctions

    One month

Study Arms (2)

Education about PF

EXPERIMENTAL

Education about PF. Participants will attend three 60-minutes educational online sessions.

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.

Interventions

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.

Education about PF

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Non applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Balearic Islands

Palma de Mallorca, Balearic Islands, 07122, Spain

Location

Related Publications (4)

  • 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.

    PMID: 32217913BACKGROUND
  • Rashidi 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.

    PMID: 33435931BACKGROUND
  • Elenskaia 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.

    PMID: 21935649BACKGROUND
  • Reynolds 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.

    PMID: 31059664BACKGROUND

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Study Officials

  • Natalia Romero-Franco, PhD

    University of the Balearic Islands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A quasiexperimental controlled trial is designed, with two arms: an experimental group and a control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2024

First Posted

April 9, 2024

Study Start

April 9, 2024

Primary Completion

May 22, 2024

Study Completion

June 20, 2024

Last Updated

October 15, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations