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Effects of a Multimodal and Multidimensional Intervention on Urinary Incontinence in Young Nulliparous Female Athletes. (PELVICATHLE)

8. juni 2026 opdateret af: Centre Hospitalier Universitaire de Saint Etienne

Effects of a Multimodal and Multidimensional Intervention on Urinary Incontinence in Young Nulliparous Female Athletes. Single-Center Randomized Controlled Stepped-Wedge Trial

A prevalence of urinary incontinence ranging from 5.7% to 80% has been observed in young nulliparous athletes during their activity.

The usual recommendations for managing adult women do not seem to be transferable.

Young nulliparous athletes need specific educational and behavioral interventions and an alternative to pelvic floor muscle strengthening.

A multimodal and multidimensional intervention for athletes and coaches combining specific pelvic health education and strengthening of lumbopelvic-abdominal stability appears to be an innovative and optimal solution for reducing the symptoms of urinary incontinence in young nulliparous women who participate in athletics.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

198

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Frankrig
      • Saint-Etienne, Frankrig, 42055
        • CHU de Saint-Etienne
        • Ledende efterforsker:
          • Pascal EDOUARD, PHD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria :

  • Female subject, nulliparous
  • Member of an athletics club affiliated with the French Athletics Federation (FFA)
  • At least 15 years old at the start of the study and belonging to the U16/U18/U20/U23 categories (born between January 1, 2005, and September 1, 2011)
  • Having internet access
  • Having access to a digital device (computer, tablet, mobile phone)
  • Affiliated with or covered by a social security scheme
  • Having freely given their express consent, as well as the express consent of both parents for minor participants

Exclusion Criteria :

  • Any individual deprived of their liberty or subject to legal protection (guardianship, curatorship, or protective supervision).
  • A pregnant woman, a woman who has been pregnant, or a woman planning a pregnancy within the last nine months.
  • Any individual unable to understand the purpose and conditions of the study.
  • Any individual unable to give their consent.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Control condition
Usual activities
Andet: Usual activities
Collection of data on routine activities
Eksperimentel: Interventional condition
Combined pelvic health education and lumbar-pelvic-abdominal stability strengthening program.
Andet: Combined pelvic health education and lumbar-pelvic-abdominal stability strengthening programme.

The intervention will consist of participants:

i) reviewing educational content (8 educational videos online)

ii) participating in two in-person sessions at the athletics club and performing lumbar-pelvic-abdominal stability exercises

iii) learning and implementing recommendations for empowering themselves in pelvic health management.

iv) complete reports in 6 questionnaires during follow-up.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Urinary incontinence symptoms
Tidsramme: Week 1, 7, 13, 19, 25, 31
Severity of urinary incontinence symptoms as measured by the ICIQ-UI-SF score (International Consultation on Incontinence Questionnaire - Short Form for Urinary Incontinence). Scores typically range from 0 to 21. The higher the score, the more severe the urinary incontinence.
Week 1, 7, 13, 19, 25, 31

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The program's effects on the prevalence of urinary incontinence
Tidsramme: Week 1, 7, 13, 19, 25, 31
The program's effects on the prevalence of urinary incontinence will be measured using the ICIQ-UI-SF questionnaire, with a dichotomous interpretation of the score: 0 = continent, ≥1 = incontinent.
Week 1, 7, 13, 19, 25, 31
Effects of the intervention on athletes' knowledge of the pelvic-perineal region
Tidsramme: Week 1, 31
A questionnaire we have developed will measure the effects of the intervention on athletes' knowledge of the pelvic and perineal region. It will consist of 10 questions. This outcome will be assessed by comparing the mean number of correct answers (on a scale of 0 to 10) within and between groups.
Week 1, 31
The program's effects on associated pelvic and perineal symptoms
Tidsramme: Week 1, 31
The ODS-S questionnaires measure associated pelvic and perineal symptoms. This criterion will be assessed by comparing the mean total scores (on a scale of 0 to 20) within and between groups.
Week 1, 31
The program's effects on urinary dysfunction.
Tidsramme: Week 1, 31
Section C of the LURN-SI29 questionnaire, which assesses urinary dysfunction. This criterion will be evaluated by comparing the mean total scores (on a scale of 0 to 20) within and between groups.
Week 1, 31
Number of educational contents viewed
Tidsramme: Week 13, 19, 25
Measured by tracking content views at the end of the session.
Week 13, 19, 25
Practicing lower back, pelvic, and abdominal stability exercises
Tidsramme: Week 1, 7, 13, 19, 25, 31
Measured by collecting the frequency of implementation.
Week 1, 7, 13, 19, 25, 31
The dose-response effect related to adherence
Tidsramme: Week 1, 7, 13, 19, 25, 31
Assessed by measuring the effects on the ICIQ-UI-SF score based on the frequency of exercise implementation. Scores typically range from 0 to 21. The higher the score, the more severe the urinary incontinence.
Week 1, 7, 13, 19, 25, 31
Program satisfaction
Tidsramme: Week 31
Assessed using a questionnaire. This criterion will be expressed as the average of the total scores for the satisfaction and recommendation questions (on a scale of 0 to 10). A score of "10" indicates high satisfaction and a strong recommendation.
Week 31
Trends in Top Athletic Performance
Tidsramme: Week 1, 7, 13, 19, 25, 31

Measured by the best performance (time/distance) in the most common track and field event.

Time is measured in seconds and minutes. Distance is measured in meters.
Week 1, 7, 13, 19, 25, 31
Number of educational contents viewed by coaches
Tidsramme: Week 13, 19, 25
Measured by tracking content views at the end of the session
Week 13, 19, 25
Coaches' level of knowledge regarding the pelvic-perineal region
Tidsramme: Week 1, 31
Assessed using a 10-question questionnaire. This criterion will be expressed through an intra-group and inter-group comparison of the average number of correct answers (on a scale of 0 to 10).
Week 1, 31
Practicing lumbar-pelvic-abdominal stability exercises
Tidsramme: Week 1, 7, 13, 19, 25, 31
Measured by collecting the frequency as specified in a questionnaire
Week 1, 7, 13, 19, 25, 31
Coaches' satisfaction with the program
Tidsramme: Week 31
Assessed using a questionnaire. This criterion will be expressed as the average of the total scores for the satisfaction and recommendation questions (on a scale of 0 to 10). A score of "10" indicates high satisfaction and a strong recommendation.
Week 31

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Efterforskere

  • Ledende efterforsker: Pascal EDOUARD, PHD, CHU de Saint-Etienne

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 26CH163
  • ANSM (Anden identifikator: 2026-A01275-46)

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