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

June 8, 2026 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Saint-Etienne, France, 42055
        • CHU de Saint-Etienne
        • Principal Investigator:
          • Pascal EDOUARD, PHD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control condition
Usual activities
Other: Usual activities
Collection of data on routine 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary incontinence symptoms
Time Frame: 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.
Week 1, 7, 13, 19, 25, 31

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Pascal EDOUARD, PHD, CHU de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26CH163
  • ANSM (Other Identifier: 2026-A01275-46)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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