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

NCT07644273 — Not applicable, Recruiting, 198 participants, Centre Hospitalier Universitaire de Saint Etienne

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

RegistryNCT07644273, acronym PELVICATHLE
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, sequential, masking: none, other
Enrollment198 (Estimated)
SponsorCentre Hospitalier Universitaire de Saint Etienne (Other)
ConditionsUrinary Incontinence
InterventionsCombined pelvic health education and lumbar-pelvic-abdominal stability strengthening programme., Usual activities (Other)
Datesstart 2026-09-17, primary completion 2027-06-01 (estimated), completion 2027-06-01 (estimated), first posted 2026-06-12, last updated 2026-09-30
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Urinary Incontinence All trials of Combined pelvic health education and lumbar-pelvic-abdominal stability strengthening programme. All trials of Usual activities

-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
Control conditionActive comparatorOther: Usual activitiesUsual activities
Interventional conditionExperimentalOther: Combined pelvic health education and lumbar-pelvic-abdominal stability strengthening programme.Combined pelvic health education and lumbar-pelvic-abdominal stability strengthening program.
  • 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

+Outcome measures

Primary outcomes

  • Urinary incontinence symptoms [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

  • The program's effects on the prevalence of urinary incontinence [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.
  • Effects of the intervention on athletes' knowledge of the pelvic-perineal region [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.
  • The program's effects on associated pelvic and perineal symptoms [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.
  • The program's effects on urinary dysfunction. [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.
  • Number of educational contents viewed [Week 13, 19, 25]: Measured by tracking content views at the end of the session.
  • Practicing lower back, pelvic, and abdominal stability exercises [Week 1, 7, 13, 19, 25, 31]: Measured by collecting the frequency of implementation.
  • The dose-response effect related to adherence [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.
  • Program satisfaction [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.
  • Trends in Top Athletic Performance [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.
  • Number of educational contents viewed by coaches [Week 13, 19, 25]: Measured by tracking content views at the end of the session
  • Coaches' level of knowledge regarding the pelvic-perineal region [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).
  • Practicing lumbar-pelvic-abdominal stability exercises [Week 1, 7, 13, 19, 25, 31]: Measured by collecting the frequency as specified in a questionnaire
  • Coaches' satisfaction with the program [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.

+Eligibility

Sex: Female, ages: 15 Years to 40 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
CHU de Saint-EtienneSaint-EtienneFranceRecruiting

+Investigators

  • Pascal EDOUARD, PHD, Principal investigator, CHU de Saint-Etienne