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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07644273
Acronym
PELVICATHLE
Enrollment
198
Registered
2026-06-12
Start date
2026-09-01
Completion date
2027-06-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Keywords

Urinary incontinence, women's health, track and field

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.

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.

Collection of data on routine activities

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE

Intervention model description

A stepped-wedge randomized controlled trial using closed cohort sampling

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Urinary incontinence symptomsWeek 1, 7, 13, 19, 25, 31Severity 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

MeasureTime frameDescription
The program's effects on the prevalence of urinary incontinenceWeek 1, 7, 13, 19, 25, 31The 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 regionWeek 1, 31A 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 symptomsWeek 1, 31The 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, 31Section 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 viewedWeek 13, 19, 25Measured by tracking content views at the end of the session.
Practicing lower back, pelvic, and abdominal stability exercisesWeek 1, 7, 13, 19, 25, 31Measured by collecting the frequency of implementation.
The dose-response effect related to adherenceWeek 1, 7, 13, 19, 25, 31Assessed 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 satisfactionWeek 31Assessed 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 PerformanceWeek 1, 7, 13, 19, 25, 31Measured 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 coachesWeek 13, 19, 25Measured by tracking content views at the end of the session
Coaches' level of knowledge regarding the pelvic-perineal regionWeek 1, 31Assessed 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 exercisesWeek 1, 7, 13, 19, 25, 31Measured by collecting the frequency as specified in a questionnaire
Coaches' satisfaction with the programWeek 31Assessed 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.

Countries

France

Contacts

CONTACTPascal EDOUARD, PHD
pascal.edouard@univ-st-etienne.fr(0)477127985
CONTACTCéline PEURIERE, CDP
Celine.Peuriere@chu-st-etienne.fr(0)477120285
PRINCIPAL_INVESTIGATORPascal EDOUARD, PHD

CHU de Saint-Etienne

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026