Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?
NCT ID: NCT05773378
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2023-04-14
2025-09-01
Brief Summary
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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.
Detailed Description
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Urinary continence is maintained as long as urethral closure pressure remains higher than bladder pressure. This is accomplished through a complex combination of mechanisms, including smooth and striated urethral sphincter muscle action, urethral venous engorgement and mucous secretions within the urethra, and the proper transfer of loads to the urethra, which depends on adequate bladder neck and urethral connective tissue support as well as pelvic floor muscle (PFM) action. The associations among physical activity, pelvic floor morphology and function, and UI are not clear. A recent systematic review retrieved 18 mainly small studies investigating the association between physical activity and pelvic floor dysfunction. Exercise at mild to moderate intensity appears to be protective, decreasing both the odds and the risk of experiencing urinary incontinence. However, females who engage in high-impact activities such as running are more likely to report UI during exercise than those who engage in mild or moderate intensity exercise, thus chronic and repetitive loading of the pelvic floor may have negative consequences.
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 investigated about interventions specific to running-induced UI.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pessary Intervention
Participants randomized to this group will receive an Uresta Incontinence Pessary to use each time they run over a 10-week period. They will be instructed to use the pessary only while running and remove it and wash it with soap and water when the training is over.
Uresta is a reusable and removable device made of hypoallergenic medical-grade resin that is inserted into the vagina to provide mechanical support. It comes with a starter kit with 3 different sizes which work for over 80% of women. Participants will be instructed on how to test the 3 sizes to find out which one is right for them.
Pessary Intervention
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.
Tampon Intervention
Participants randomized to this group will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 10-week period. The tampon should be used only while running and removed and discarded when the training is over. Four weeks after the intervention (at the 16 weeks follow-up), they will receive a pessary with instruction how to use it if they desire so.
Tampon Intervention
Participants will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 10-week period.
Control Group
Participants randomized to this group won't receive any intervention and will be asked to continue their running training as usual for 10-weeks. They will also be instructed to not begin any treatment for urinary incontinence until their reassessment. Four weeks after the intervention (at the 16 weeks follow-up), they will receive a pessary with instruction how to use it if they desire so.
No interventions assigned to this group
Interventions
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Pessary Intervention
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.
Tampon Intervention
Participants will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 10-week period.
Eligibility Criteria
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Inclusion Criteria
* Who regularly (≥ 1 per week) experience urine leakage while running.
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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University of Ottawa
OTHER
Responsible Party
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Dr. Linda McLean
Professor in the School of Rehabilitation Sciences at University of Ottawa
Principal Investigators
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Linda McLean
Role: PRINCIPAL_INVESTIGATOR
University of Ottawa
Locations
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McLean Function Measurement Lab
Ottawa, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Anne-Marie MacDonald, MSc
Role: primary
Linda McLean, PhD
Role: backup
Linda McLean, PhD
Role: backup
References
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Vesting S, Petter Rodrigues M, Collins G, McLean L. Intravaginal devices for running-induced urinary incontinence symptoms in females: a study protocol. BJU Int. 2025 Jun;135(6):931-939. doi: 10.1111/bju.16708. Epub 2025 Mar 12.
Other Identifiers
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H-06-22-8219
Identifier Type: -
Identifier Source: org_study_id