Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners? (NCT05773378)
🩺 Plain-English Summary (8th-Grade Level)
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 predominantly during running.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (10 items).
Location: McLean Function Measurement Lab — Ottawa, Ontario
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- McLean Function Measurement Lab — Ottawa, Ontario
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.