NCT05773378 Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?
| NCT ID | NCT05773378 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Ottawa |
| Condition | Urinary Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-04-14 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2023-04-14 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Linda McLean
PRINCIPAL INVESTIGATOR
University of Ottawa
Frequently Asked Questions
Who can join the NCT05773378 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05773378 currently recruiting?
Yes, NCT05773378 is actively recruiting participants. Contact the research team at lmclea2@uottawa.ca for enrollment information.
Where is the NCT05773378 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT05773378 clinical trial?
NCT05773378 is sponsored by University of Ottawa. The principal investigator is Linda McLean at University of Ottawa. The trial plans to enroll 90 participants.