NCT07644273

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

9 months

First QC Date

June 2, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

Urinary incontinencewomen's healthtrack and field

Outcome Measures

Primary Outcomes (1)

  • Urinary incontinence symptoms

    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

Secondary Outcomes (13)

  • The program's effects on the prevalence of urinary incontinence

    Week 1, 7, 13, 19, 25, 31

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

    Week 1, 31

  • The program's effects on associated pelvic and perineal symptoms

    Week 1, 31

  • The program's effects on urinary dysfunction.

    Week 1, 31

  • Number of educational contents viewed

    Week 13, 19, 25

  • +8 more secondary outcomes

Study Arms (2)

Control condition

ACTIVE COMPARATOR

Usual activities

Other: Usual activities

Interventional condition

EXPERIMENTAL

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

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

Interventions

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.

Interventional condition

Collection of data on routine activities

Control condition

Eligibility Criteria

Age15 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pascal EDOUARD, PHD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: A stepped-wedge randomized controlled trial using closed cohort sampling
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 12, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

June 12, 2026

Record last verified: 2026-06

Locations