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Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated December 17, 2024 (before its estimated September 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: Feb 1, 2025 to Sep 1, 2025v4 Show 4 more changesShow less
    • Primary endpoints: 6 to 5
    • Secondary endpoints: 8 to 10
    • Site contact updated
    • Eligibility criteria expanded, about 1 word
  2. Primary endpoints: 5 to 6
    • Secondary endpoints: 7 to 8
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 21, 2023 to Apr 14, 2023
    • Site details revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05773378
Lead Sponsor University of Ottawa
Conditions
(from sponsor)		 Urinary Incontinence
Related terms Urinary Incontinence
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov