Using intravaginal devices to help female runners with urinary incontinence
Do Intravaginal Devices Reduce or Eliminate Exercise Induced Urinary Incontinence in Female Runners?
This study is testing whether using intravaginal devices like pessaries and tampons can help female runners who experience urine leakage while exercising.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Ottawa Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT05773378 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of intravaginal devices, specifically pessaries and tampons, in reducing urinary incontinence (UI) among female runners. It aims to address the significant issue of UI that affects many women during physical activity, particularly running, which can lead to decreased participation in exercise and negatively impact their quality of life. The study will involve female participants who regularly experience urine leakage while running and will assess the impact of these devices on their symptoms. By focusing on a specific population of active women, the research seeks to provide targeted solutions for managing UI during high-impact activities.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 18 and over who run at least twice a week and experience urine leakage while running.
Not a fit: Patients who have a history of urogenital surgery, neurological disorders, or are currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide female runners with effective tools to manage urinary incontinence, allowing them to maintain their physical activity and improve their quality of life.
How similar studies have performed: While there is existing evidence for the use of pelvic floor muscle training and pessaries in general populations, this specific approach targeting female runners is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Females aged 18 years and over who run at least twice a week for a minimum of 10K/week (minimum speed of 6 km/h to ensure high impact), who have done so for at least 6 months (to ensure adequate duration of exposure), and who commit to continue the same amount during the study period * Who regularly (≥ 1 per week) experience urine leakage while running. Exclusion Criteria: * Any risk factors related to exercise; * Pain or musculoskeletal injury at the time of the screening; * History of urogenital surgery; * Symptoms of the female athlete triad; * Have a known neurologic disorder (e.g. stroke, multiple sclerosis); * Pregnancy or partum within the previous year; For the in-lab assessment: * Ability to run with a moderately full bladder for 38 minutes on a treadmill * BMI ≥ 30 * Pelvic organ prolapse ≥ 2
Where this trial is running
Ottawa, Ontario
- McLean Function Measurement Lab — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Linda McLean — University of Ottawa
- Study coordinator: Linda McLean
- Email: lmclea2@uottawa.ca
- Phone: 613-562-5800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.