Clinical trial NCT05773378: Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?
Official title: Do Intravaginal Devices Reduce or Eliminate Exercise Induced Urinary Incontinence in Female Runners?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Keywords: exercise-induced urinary incontinence
running-induced urinary incontinence
intravaginal pessary
tampon
pelvic floor
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Urinary incontinence (UI) is a serious public health concern, imposing a significant financial burden. In Canada the direct and indirect health costs associated with UI total over 3.6 billion annually and no estimates of disease burden take into account deconditioning that results from withdrawal from physical activity nor effects on mental health or quality of life. Although the primary risk factor for UI is pregnancy and vaginal delivery, it was recently reported that between 20% and 40% of nulliparous females report urine leakage when they engage in physical activity.

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.

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

Primary outcomes:
measure: Urinary leakage tracking: Proportion of training sessions during which urine leakage occurred
timeFrame: at baseline, and during intervention week 10-12
measure: Patient's global impression of improvement
timeFrame: Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
measure: Patient's global satisfaction with treatment
timeFrame: Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
measure: International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS)
timeFrame: Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
measure: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
timeFrame: Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
Secondary outcomes:
measure: Intervention questionnaire
timeFrame: Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
measure: Adherence to each intervention
timeFrame: Once a week during the 12 weeks of the study
measure: Unintended effects
timeFrame: Once a week during the 12 weeks of the study
measure: Brisk walking and Running lower Urinary Tract Symptoms Questionnaire (BRUTS) score
timeFrame: Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
measure: Changes in bladder neck height
timeFrame: Baseline and post intervention (at 12 weeks)
measure: Changes in levator hiatus area
timeFrame: Baseline and post intervention (at 12 weeks)
measure: Changes in levator plate length
timeFrame: Baseline and post intervention ( at 12 weeks)
measure: Changes in pelvic floor muscle strength
timeFrame: Baseline and post intervention ( at 12 weeks)
measure: Changes in pelvic floor muscle stiffness
timeFrame: Baseline and post intervention ( at 12 weeks)
measure: Pad weight gain
timeFrame: Baseline and post intervention ( at 12 weeks)
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: McLean Function Measurement Lab
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Linda McLean
role: PRINCIPAL_INVESTIGATOR
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