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RecruitingNCT07644273PELVICATHLEUpdated Sep 30, 2026

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

An interventional study of Combined pelvic health education and lumbar-pelvic-abdominal stability strengthening programme. and Usual activities in Urinary Incontinence, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Recruiting at 1 site in France. Open to female participants aged 15 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Sep 30, 2026Now RecruitingSite recruiting status changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
198
Allocation
Randomized
Ages
15 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Urinary Incontinence

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Keywords

  • Urinary incontinence
  • women's health
  • track and field
03

In context

Urinary Incontinence

983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.

This study's planned enrollment of 198 is above the median of 66 across 739 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
198 participants (estimated)

Study arms

  • Active comparator
    Control condition

    Usual activities

    Other: Usual activities

  • Experimental
    Interventional condition

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

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

Interventions

  • OtherCombined 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.

  • OtherUsual activities

    Collection of data on routine activities

06

What researchers measure

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.

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

Secondary outcomes

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

    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.

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

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

    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.

    Time frame: Week 1, 31

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

    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.

    Time frame: Week 1, 31

  4. The program's effects on urinary dysfunction.

    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.

    Time frame: Week 1, 31

  5. Number of educational contents viewed

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

    Time frame: Week 13, 19, 25

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

    Measured by collecting the frequency of implementation.

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

  7. The dose-response effect related to adherence

    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.

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

  8. Program satisfaction

    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.

    Time frame: Week 31

  9. Trends in Top Athletic Performance

    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.

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

  10. Number of educational contents viewed by coaches

    Measured by tracking content views at the end of the session

    Time frame: Week 13, 19, 25

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

    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).

    Time frame: Week 1, 31

  12. Practicing lumbar-pelvic-abdominal stability exercises

    Measured by collecting the frequency as specified in a questionnaire

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

  13. Coaches' satisfaction with the program

    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.

    Time frame: Week 31

07

Study locations

1 of 1 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Sep 30, 2026
Sites
CHU de Saint-Etienne is now Recruiting
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Not yet recruiting→Recruiting
    CHU de Saint-Etienne is now Recruiting
    + 1 other change: date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07644273
Responsible party
Sponsor
First posted
Jun 12, 2026
Start date
Sep 17, 2026
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Pascal EDOUARD, PHD
Contact
pascal.edouard@univ-st-etienne.fr
(0)477127985 ext. +33
Céline PEURIERE, CDP
Contact
Celine.Peuriere@chu-st-etienne.fr
(0)477120285 ext. +33
Pascal EDOUARD, PHD
principal investigator · CHU de Saint-Etienne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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