Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?
Do Intravaginal Devices Reduce or Eliminate Exercise Induced Urinary Incontinence in Female Runners?
University of Ottawa
90 participants
Apr 14, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 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 Criteria10
- 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
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Interventions
Participants will receive a 3-size fitting kit and will fit the appropriate size based on manufacturer instruction. Once the size is verified, the participants will be asked to use the pessary while running over a 10-week period.
Participants will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 10-week period.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05773378