Urinary Stress IncontinenceIU-TRAILNCT06469320
Urinary Incontinence and Other Pelvic Floor Dysfunctions in Trail Runners
An observational study of Urinary Stress Incontinence, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Stress Incontinence
- What is being tested?
- Online questionnaire
- How many people
- 1,500 participants
- Where
- 1 siteReunion
- Study dates
- 25 Jul 2024to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Adult, Older adult
Study population: Adult french woman practising trail-running
Who may be able to join
- 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-
Who cannot join
- Pregnant or have given birth in the last six months
- Does not understand French
- A protected adult (guardianship or curatorship) or under court protection
Trial locations and contacts
1 site in 1 country.
Reunion1 site, 1 recruiting
- Recruiting
CHU la Réunion
Saint-Denis, 97400
Nicolas BOUSCAREN, MD
Laetitia BERLY, PhD
About this study
Official title: 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.
- Conditions
- Urinary Stress Incontinence
- Being tested
- Online questionnaire
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online questionnaireOther
Pelvic floor dysfunction assessment questionnaire adapted from PFD-Sentinel
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start25 Jul 2024
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Stress 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Bouscaren, MD, Principal investigator, CHU La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469320
- Sponsor's protocol ID
- 2024/CHU/13
- Acronym
- IU-TRAIL
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Incontinence and Other Pelvic Floor Dysfunctions in Trail Runners: Epidemiology and Identification of Risk Factors
- ClinicalTrials.gov ID
- NCT06469320
- Acronym / sponsor ID
- IU-TRAIL / 2024/CHU/13
- Conditions
- Urinary Stress Incontinence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Adult french woman practising trail-running
Key inclusion criteria (4 listed)
- 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-
Key exclusion criteria (3 listed)
- Pregnant or have given birth in the last six months
- Does not understand French
- A protected adult (guardianship or curatorship) or under court protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online questionnairePelvic floor dysfunction assessment questionnaire adapted from PFD-Sentinel | Other | – |
Primary outcome
Prevalence of stress urinary incontinence (SUI) and pelvic floor dysfunction (PFD)
Time frame: 6 months
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.
2 secondary outcomes
Identify the risk factors associated with SUI and PFD in French trail runners.
Time frame: 6 months
To assess the impact of SUI and PFD on the sporting activities and daily lives of French trail runners
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Bouscaren, MD principal investigator
CHU La Réunion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Stress Incontinence, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Bouscaren, MD (+262 (0)2 62 35 90 00, nicolas.bouscaren@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of stress urinary incontinence (SUI) and pelvic floor dysfunction (PFD) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.