NCT06469320

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

July 25, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

August 7, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

June 17, 2024

Last Update Submit

August 6, 2024

Conditions

Outcome Measures

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.

    6 months

Secondary Outcomes (2)

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

    6 months

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

    6 months

Interventions

Pelvic floor dysfunction assessment questionnaire adapted from PFD-Sentinel

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult french woman practising trail-running

You may qualify if:

  • 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-

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU la Réunion

Saint-Denis, 97400, Reunion

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas Bouscaren, MD

    CHU La Réunion

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2024

First Posted

June 21, 2024

Study Start

July 25, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

August 7, 2024

Record last verified: 2024-06

Locations