Urinary IncontinencePELVICATHLENCT07644273
Effects of a Multimodal and Multidimensional Intervention on Urinary Incontinence in Young Nulliparous Female Athletes.
A study testing Combined pelvic health education and lumbar-pelvic-abdominal stability strengthening programme. and Usual activities in people with Urinary Incontinence, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Combined pelvic health education and lumbar-pelvic-abdominal stability strengthening programme. and Usual activities
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2026to Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42055
Pascal EDOUARD, PHD, (0)477127985 ext. +33, pascal.edouard@univ-st-etienne.fr
Pascal EDOUARD, PHD
About this study
Official title: 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.
- Conditions
- Urinary Incontinence
- Being tested
- Combined pelvic health education and lumbar-pelvic-abdominal stability strengthening programme., Usual activities
- Keywords
- Urinary incontinence, women's health, track and field
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined pelvic health education and lumbar-pelvic-abdominal stability strengthening programme.Other
The intervention will consist of participants:
- 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.
Usual activitiesOther
Collection of data on routine activities
| Study group | Role | What they receive |
|---|---|---|
| Control condition | Active comparator | Usual activities Receives: Other: Usual activities |
| Interventional condition | Experimental | Combined pelvic health education and lumbar-pelvic-abdominal stability strengthening program. Receives: Other: Combined pelvic health education and lumbar-pelvic-abdominal stability strengthening programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1, 7, 13, 19, 25, 31
Secondary outcomes (13)
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.
Measured: Week 1, 7, 13, 19, 25, 31
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.
Measured: Week 1, 31
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.
Measured: Week 1, 31
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.
Measured: Week 1, 31
Number of educational contents viewed
Measured by tracking content views at the end of the session.
Measured: Week 13, 19, 25
Practicing lower back, pelvic, and abdominal stability exercises
Measured by collecting the frequency of implementation.
Measured: Week 1, 7, 13, 19, 25, 31
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.
Measured: Week 1, 7, 13, 19, 25, 31
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.
Measured: Week 31
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.
Measured: Week 1, 7, 13, 19, 25, 31
Number of educational contents viewed by coaches
Measured by tracking content views at the end of the session
Measured: Week 13, 19, 25
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).
Measured: Week 1, 31
Practicing lumbar-pelvic-abdominal stability exercises
Measured by collecting the frequency as specified in a questionnaire
Measured: Week 1, 7, 13, 19, 25, 31
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.
Measured: Week 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start17 Sep 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A stepped-wedge randomized controlled trial using closed cohort sampling
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal EDOUARD, PHD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644273
- Sponsor's protocol ID
- 26CH163
- Other IDs
- ANSM
- Acronym
- PELVICATHLE
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No