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Search / Trial NCT05773378

Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?

Launched by UNIVERSITY OF OTTAWA · Mar 6, 2023

Trial Information

Current as of November 09, 2025

Recruiting

Keywords

Exercise Induced Urinary Incontinence Running Induced Urinary Incontinence Intravaginal Pessary Tampon Pelvic Floor

ClinConnect Summary

This clinical trial is studying whether using special devices placed inside the vagina can help female runners who experience urinary incontinence, which is the involuntary leakage of urine, particularly while exercising. Many women feel embarrassed and limit their activities because of this issue, and the trial aims to find effective ways to manage it so that they can continue to enjoy running and stay healthy.

To be eligible for the trial, participants need to be women aged 18 and older who run at least 5 kilometers twice a week and have experienced urine leakage while running regularly. It’s important that they’ve been running for at least a year and do not have certain health issues that could affect their participation. If they join the study, participants can expect to use the intravaginal devices and share their experiences, helping researchers understand if these devices can improve their running experience and overall quality of life.

Gender

FEMALE

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

About University Of Ottawa

The University of Ottawa, a leading research institution in Canada, is dedicated to advancing healthcare through innovative clinical trials and studies. With a commitment to excellence in research and a robust network of interdisciplinary collaboration, the university leverages its expertise in various medical fields to enhance patient care and public health outcomes. The institution fosters an environment that promotes ethical research practices, ensuring the safety and well-being of participants while contributing to the scientific community's understanding of diverse health issues. Through its clinical trial initiatives, the University of Ottawa aims to translate research findings into tangible benefits for society.

Locations

Ottawa, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Linda McLean

Principal Investigator

University of Ottawa

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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