A population-based study of urinary symptoms and incontinence: the Canadian Urinary Bladder Survey.
Sender Herschorn, Jerzy Gajewski, Jane Schulz...
https://pubmed.ncbi.nlm.nih.gov/17908260Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID05773378
Do Intravaginal Devices Reduce or Eliminate Exercise Induced Urinary Incontinence in Female Runners?
Led by University of Ottawa · Updated on 2024-12-17
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Urinary incontinence (UI) during exercise is a common issue affecting more than one in five females, often causing embarrassment and leading many to reduce or stop physical activity. This study focuses on female runners who experience urine leakage during running, a high-impact activity that may worsen UI. The trial aims to evaluate the effect of intravaginal devices specifically on UI caused by running, as no prior study has targeted this group despite evidence supporting pelvic floor muscle training and pessaries for general UI. The study compares three groups over a 10-week period: one group will use an intravaginal pessary device called Uresta during running sessions, another will use regular tampons during running, and a control group will continue their usual running routine without any intervention. The Uresta pessary is a reusable device available in three sizes, providing mechanical support when inserted vaginally, while tampon use is limited to running times and then discarded. After the 10-week intervention, all participants will have follow-up assessments up to 36 weeks, and control or tampon groups may receive the pessary later if desired. Participants will be monitored through various assessments including urine leakage tracking during training, patient-reported improvement and satisfaction, and validated questionnaires on urinary symptoms at baseline, post-intervention, and follow-ups. Additional measures include pelvic floor muscle strength and imaging assessments before and after the intervention. Weekly check-ins will track adherence and any unintended effects. The total study duration includes the intervention period and follow-ups extending to 36 weeks after starting treatment.
CONDITIONS
Brief Title
Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Female, aged 18 years or older
- Runs at least twice a week covering a minimum of 10 kilometers per week at a speed of 6 km/h or more
- Has been running this amount consistently for at least 6 months
- Regularly experiences urine leakage while running at least once per week
- Commits to continuing the same running amount during the study period
You will not qualify if you...
- Any risk factors related to exercise
- Current pain or musculoskeletal injury at screening
- History of urogenital surgery
- Symptoms of the female athlete triad
- Known neurologic disorders such as stroke or multiple sclerosis
- Pregnant or gave birth within the past 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 stage 2 or greater
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 10 weeks
Participants use either an intravaginal pessary or tampons during their running sessions over a 10-week period, or continue running without intervention if assigned to the control group.
Weekly visits for up to 12 weeks
Follow-up
Duration - 24 weeks
Participants are assessed for urinary incontinence symptoms and satisfaction with the intervention at multiple time points after treatment ends.
Visits at 16, 24, and 36 weeks post-treatment
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
S
Sabine Vesting
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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