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NCT Number: NCT07644273

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

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

15 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location contact

Pascal EDOUARD, PHD

CONTACT

[email protected]

(0)477127985 ext. +33

Pascal EDOUARD, PHD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combined pelvic health education and lumbar-pelvic-abdominal stability strengthening programme.

Other

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.

Usual activities

Other

Collection of data on routine activities

Primary outcomes

  1. Urinary incontinence symptoms

    Time frame: 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.

Secondary outcomes

  1. The program's effects on the prevalence of urinary incontinence

    Time frame: 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.

  2. Effects of the intervention on athletes' knowledge of the pelvic-perineal region

    Time frame: 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.

  3. The program's effects on associated pelvic and perineal symptoms

    Time frame: 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.

  4. The program's effects on urinary dysfunction.

    Time frame: 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.

  5. Number of educational contents viewed

    Time frame: Week 13, 19, 25

    Measured by tracking content views at the end of the session.

  6. Practicing lower back, pelvic, and abdominal stability exercises

    Time frame: Week 1, 7, 13, 19, 25, 31

    Measured by collecting the frequency of implementation.

  7. The dose-response effect related to adherence

    Time frame: 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.

  8. Program satisfaction

    Time frame: 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.

  9. Trends in Top Athletic Performance

    Time frame: 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.

  10. Number of educational contents viewed by coaches

    Time frame: Week 13, 19, 25

    Measured by tracking content views at the end of the session

  11. Coaches' level of knowledge regarding the pelvic-perineal region

    Time frame: 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).

  12. Practicing lumbar-pelvic-abdominal stability exercises

    Time frame: Week 1, 7, 13, 19, 25, 31

    Measured by collecting the frequency as specified in a questionnaire

  13. Coaches' satisfaction with the program

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Céline PEURIERE, CDP

CONTACT

[email protected]

(0)477120285 ext. +33

Pascal EDOUARD, PHD

CONTACT

[email protected]

(0)477127985 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: PELVICATHLE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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