ClinicalTrials.gg
RecruitingNCT06469320IU-TRAILUpdated Aug 7, 2024

Urinary Incontinence and Other Pelvic Floor Dysfunctions in Trail Runners

An observational study in Urinary Stress Incontinence, sponsored by Centre Hospitalier Universitaire de la Réunion. Recruiting at 1 site in Réunion. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-07.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
Female
01

Study summary

The pelvic floor is a crucial complex for many bodily functions, supporting the pelvic organs and contributing to urinary and anal continence, as well as sexual function. Dysfunction of this structure can lead to a variety of disorders, including urinary incontinence (UI), a common problem in women. Although the prevalence of UI in middle-aged women has been documented at between 20% and 30%, high-impact physical activities, such as certain sports and running, increase the risk of UI. According to the most recently published meta-analysis, the prevalence is 44% [95%CI 30.2-57.8]. Although this subject is often taboo, it can have psychosocial consequences and affect sporting activities. Only 31.7% of female runners talk to a health professional about it. Trail running, a fast-growing discipline, differs from road running in its particular physical demands, which could influence the occurrence of pelvic floor disorders (PFD) and exercise-induced UTIs. The unique characteristics of trail running, such as the technical nature of the terrain, the steep gradients and the variety of distances, place intense demands on the female pelvi-perineal system. Nevertheless, despite the growing popularity of this sport, little epidemiological data exists on the prevalence of stress UTI and pelvic floor disorders among female trail runners.

02

Conditions studied

  • Urinary Stress Incontinence
03

In context

Urinary Incontinence, Stress

651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 130 across 127 observational studies indexed under Urinary Incontinence, Stress.

Browse Urinary Incontinence, Stress studies →

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Adult french woman practising trail-running

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

  • Adult runner
  • Residing in mainland France, or in French overseas departments and territories such as Guadeloupe, Martinique, French Guiana, Réunion, Mayotte and New Caledonia
  • Practising trail running on a regular basis (defined pragmatically by the participant herself), whether or not affiliated to a club
  • Able to complete the questionnaire online-

Exclusion criteria

Exclusion Criteria:

  • Pregnant or have given birth in the last six months
  • Does not understand French
  • A protected adult (guardianship or curatorship) or under court protection
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Interventions

  • OtherOnline questionnaire

    Pelvic floor dysfunction assessment questionnaire adapted from PFD-Sentinel

06

What researchers measure

Primary outcomes

  1. Prevalence of stress urinary incontinence (SUI) and pelvic floor dysfunction (PFD)

    The prevalence will be determined by determining the proportion of female trail runners reporting Stress urinary incontinence and/or Pelvic floor muscle dysfunction out of the total population of trail runners who responded to the questionnaire.

    Time frame: 6 months

Secondary outcomes

  1. Identify the risk factors associated with SUI and PFD in French trail runners.

    Identification of the relative risks of the various suspected risk factors using a multiple logistic regression model

    Time frame: 6 months

  2. To assess the impact of SUI and PFD on the sporting activities and daily lives of French trail runners

    The various repercussions listed in the questionnaires will be presented in terms of the percentage of women affected and their 95% confidence interval. The averages of the visual analog scale associated with their parameters of dispersion in order to evaluate the impact of SUI on everyday life and in their sporting activities will also be presented.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Jan 2025, 6 months after the start.

Of 39 non-industry observational studies under Urinary Incontinence, Stress, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 107. This study's planned 6 months is below that.

Counting every sponsor, half of 48 studies reached it within 45 months; a quarter within 18 and three quarters within 107.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 17, 2024
First posted
Jun 21, 2024
StartActual
Jul 25, 2024
Primary completionEst.
Jan 2025
CompletionEst.
Jan 2025
Last update
Aug 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06469320
Responsible party
Sponsor
First posted
Jun 21, 2024
Start date
Jul 25, 2024
Primary completion
Jan 2025 (estimated)
Completion
Jan 2025 (estimated)
Last update
Aug 7, 2024

Study contacts

Nicolas Bouscaren, MD
Contact
nicolas.bouscaren@chu-reunion.fr
+262 (0)2 62 35 90 00
Laetitia Berly, PhD
Contact
laetitia.berly@chu-reunion.fr
+262 262906286
Nicolas Bouscaren, MD
principal investigator · CHU La Réunion

Oversight

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

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