Using intravaginal devices to help female runners with urinary incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.