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Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?

RecruitingNAAges 18 Years - anyFemaleUniversity of Ottawa
NCT05773378 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

More than one in five females experience the embarrassment and shame of urine leakage while exercising and this urinary incontinence (UI) is a substantial barrier to exercise. As many as one in three females with UI report that they limit their physical activity due to incontinence: 11.6% by not exercising at all, 11.3% by exercising less and 12.4% by changing the type of exercise they perform. It is imperative to look for alternatives to manage this condition, as it is a key reason why females abandon the very physical exercise that is necessary to maintain or improve their physical and mental health and their quality of life. While there is Grade A evidence for pelvic floor muscle training and some evidence for intravaginal pessaries to reduce symptoms of UI in general female populations, no study has evaluated the impact of conservative interventions specifically on UI experienced pr

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📋 Eligibility rules (as published)
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
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What it tests

  • Pessary Intervention
  • Tampon Intervention
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Where

1 site
McLean Function Measurement Lab
Ottawa, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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