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Not yet recruiting NCT07644273

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

No phase Interventional Urinary Incontinence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Combined pelvic health education and lumbar-pelvic-abdominal stability strengthening programme., Usual activities.
Who it may be relevant to
Registry conditions: Urinary Incontinence. Basic parameters: 15 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other 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.
  • Other Usual activities
    Collection of data on routine activities

Primary outcome measures

  • Urinary incontinence symptoms [Time frame: Week 1, 7, 13, 19, 25, 31]
Secondary outcome measures (12)
  • The program's effects on the prevalence of urinary incontinence [Time frame: Week 1, 7, 13, 19, 25, 31]
  • Effects of the intervention on athletes' knowledge of the pelvic-perineal region [Time frame: Week 1, 31]
  • The program's effects on associated pelvic and perineal symptoms [Time frame: Week 1, 31]
  • The program's effects on urinary dysfunction. [Time frame: Week 1, 31]
  • Number of educational contents viewed [Time frame: Week 13, 19, 25]
  • Practicing lower back, pelvic, and abdominal stability exercises [Time frame: Week 1, 7, 13, 19, 25, 31]
  • The dose-response effect related to adherence [Time frame: Week 1, 7, 13, 19, 25, 31]
  • Program satisfaction [Time frame: Week 31]
  • Trends in Top Athletic Performance [Time frame: Week 1, 7, 13, 19, 25, 31]
  • Number of educational contents viewed by coaches [Time frame: Week 13, 19, 25]
  • Coaches' level of knowledge regarding the pelvic-perineal region [Time frame: Week 1, 31]
  • Practicing lumbar-pelvic-abdominal stability exercises [Time frame: Week 1, 7, 13, 19, 25, 31]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU de Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT07644273 · 26CH163 · ANSM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗