Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05773378

Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?

Led by University of Ottawa · Updated on 2024-12-17

90

Participants Needed

1

Research Sites

124 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female runners aged 18 years and older
  • Running at least twice weekly for a minimum of 10 kilometers per week at a speed of 6 km/h or higher
  • Running this amount for at least 6 months prior to the study
  • Regularly experiencing urine leakage during running at least once per week
  • Commitment to maintain the same running amount during the study period
Not Eligible

You will not qualify if you...

  • Having risk factors related to exercise
  • Experiencing pain or musculoskeletal injury at screening
  • History of urogenital surgery
  • Symptoms of the female athlete triad
  • Known neurological disorders such as stroke or multiple sclerosis
  • Pregnancy or childbirth within the previous year
  • Unable to run on a treadmill for 38 minutes with a moderately full bladder
  • Body Mass Index (BMI) of 30 or higher
  • Pelvic organ prolapse grade 2 or greater

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

McLean Function Measurement Lab

Ottawa, Ontario, Canada, K1S 1S2

Actively Recruiting

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Research Team

L

Linda McLean

CONTACT

S

Sabine Vesting

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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