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

7. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

198

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Frankrike
      • Saint-Etienne, Frankrike, 42055
        • CHU de Saint-Etienne
        • Hovedetterforsker:
          • Pascal EDOUARD, PHD
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen

Tar imot friske 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Control condition
Usual activities
Annen: Usual activities
Collection of data on routine activities
Eksperimentell: Interventional condition
Combined pelvic health education and lumbar-pelvic-abdominal stability strengthening program.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Etterforskere

  • Hovedetterforsker: Pascal EDOUARD, PHD, CHU de Saint-Etienne

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

2. juni 2026

Først innsendt som oppfylte QC-kriteriene

8. juni 2026

Først lagt ut (Faktiske)

12. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 26CH163
  • ANSM (Annen identifikator: 2024-A02435-42)

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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