Urinary Incontinence and Other Pelvic Floor Dysfunctions in Trail Runners (IU-TRAIL)

Urinary Incontinence and Other Pelvic Floor Dysfunctions in Trail Runners: Epidemiology and Identification of Risk Factors

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Stress Incontinence
• Intervention / Treatment: Other: Online questionnaire

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Nicolas Bouscaren, MD; Phone Number: +262 (0)2 62 35 90 00; Email: nicolas.bouscaren@chu-reunion.fr
• Study Contact Backup: Name: Laetitia Berly, PhD; Phone Number: +262 262906286; Email: laetitia.berly@chu-reunion.fr

Study Locations

• Réunion
  • Saint-Denis, Réunion, 97400
    • Recruiting
    • CHU La Réunion
    • Contact: Nicolas BOUSCAREN, MD
    • Contact: Laetitia BERLY, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adult french woman practising trail-running

Description

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:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion
• Investigators: Principal Investigator: Nicolas Bouscaren, MD, CHU La Réunion

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 2024/CHU/13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No