Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Do Intravaginal Devices Reduce or Eliminate Exercise Induced Urinary Incontinence in Female Runners?

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: Pessary Intervention
* Device: Tampon Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cis-females aged 18 years and over who run at least 5 km in under 50 minutes (minimum speed of 6 km/h to ensure high impact), at least twice per week (to ensure adequate frequency), and who have done so for at least one year (to ensure adequate duration of exposure); Who regularly (≥ 1 per week) experience urine leakage while running and who report ≤1 urine leakage episode per month not associated with exercise; Exclusion Criteria: Any risk factors related to exercise; If they report any pain or musculoskeletal injury at the time of the screening; History of urogenital surgery; Symptoms of the female athlete triad; Dyspareunia to the extent that they cannot undergo a regular gynaecologic examination; Have a known neurologic disorder (e.g. stroke, multiple sclerosis); Pregnancy or partum within the previous year;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pessary Intervention<br>Participants randomized to this group will receive an Uresta Incontinence Pessary to use each time they run over a 12-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. | Device: Pessary Intervention<br>* 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 12-week period.<br>|
| Experimental: Tampon Intervention<br>Participants randomized to this group will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 12-week period. The tampon should be used only while running and removed and discarded when the training is over. | Device: Tampon Intervention<br>* Participants will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 12-week period.<br>|
| No Intervention: Control Group<br>Participants randomized to this group won't receive any intervention and will be asked to continue their running training as usual for 12-weeks. They will also be instructed to not begin any treatment for urinary incontinence until their reassessment. After 12-weeks, they will be reassessed and will be offered the opportunity to receive a pessary if they desire so. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of training sessions during which urine leakage occurred | Participants will be asked to complete a bladder diary recording leakage experiences during each running session over a two-week period before their first lab assessment and over a two-week period again beginning in the tenth week after starting the protocol. They will receive daily reminders to fill it out. | 10-12 weeks | 
| Brisk walking and Running lower Urinary Tract Symptoms Questionnaire (BRUTS) score | The Brisk walking and Running Lower Urinary Tract Symptoms Questionnaire evaluates the symptoms and management strategies associated with urinary urgency and urinary incontinence that occurs during brisk walking, jogging, and running. Participants will be asked to complete it before coming for their first lab assessment and after 12-weeks. Also, a follow-up will be conducted upon finishing the intervention, and participants will be invited to complete the questionnaire again at 4, 12 and 24 weeks later. The questionnaire has 4 domains: (1) about urgency symptoms, (2) about urgency urinary incontinence (UUI), (3) about stress urinary incontinence (SUI) and (4) about symptoms management. Scores are all 0-100 and higher scores mean a worse outcome with regards to the impact of lower urinary tract symptoms. The total score is still out of 100 (Urgency + UUI + SUI + Management / 4). | 12 weeks; follow-up at 4, 12 and 24 weeks later. | 
| Patient's global perception of improvement | Participants will be asked to rate their overall impression of how much the symptoms improved with the intervention on a scale of 0 to 100 after 12-weeks. Also, a follow-up will be conducted upon finishing the intervention, and, if they are still using the intervention, participants will be invited to rate their overall impression again at 4, 12 and 24 weeks later. Higher scores mean a better outcome = more improvement. | 12 weeks; follow-up at 4, 12 and 24 weeks later. | 
| Patient's global satisfaction with treatment | Participants will be asked to rate their satisfaction with the intervention on a scale of 0 to 100 after 12-weeks. Also, a follow-up will be conducted upon finishing the intervention, and, if they are still using the intervention, participants will be invited to rate their satisfaction again at 4, 12 and 24 weeks later. Higher scores mean a better outcome = more satisfied. | 12 weeks; follow-up at 4, 12 and 24 weeks later. | 
| International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) | The ICIQ-FLUTS is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life in research and clinical practice, with validity, reliability and responsiveness established with rigour in several data sets. It has a total of 12 questions; four questions on filling symptoms, three on voiding symptoms and five questions on urinary incontinence symptoms. The overall score ranges from 0-48, where all subscales scores are added. Higher scores indicate greater impact of individual symptoms for the patient. Participants will be asked to complete it before coming for their first lab assessment and after 12-weeks. Also, a follow-up will be conducted upon finishing the intervention, and participants will be invited to complete the questionnaire again at 4, 12 and 24 weeks later. | 12 weeks; follow-up at 4, 12 and 24 weeks later. | 
| Intervention questionnaire | A custom questionnaire with 20 questions was developed to collect information regarding participant's experience running with the intervention (tampon or pessary). The questions addresses the frequency of intervention use, ease of insertion and removal, comfort level while using the device, adverse events (bleeding, vaginal discharge, pain), overall satisfaction, and the extent of urine leakage with the dispositive. Each question is rated on a scale form 0 to 100, with higher scores indicating a greater experience with the intervention. Participants randomized to the intervention groups will be asked to complete the questionnaire related to their assigned intervention after 12-weeks. Additionally, a follow-up will be conducted upon completing the intervention, and participants will be invited to complete the questionnaire again at 4, 12 and 24 weeks later. | 12 weeks; follow-up at 4, 12 and 24 weeks later. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to each intervention | Adherence to the interventions will be logged through weekly e-mail contact, followed up with telephone contact if there is no response to the e-mail. | Once a week during the 12 weeks of the study | 
| Adverse events | Adverse events (bleeding, vaginal discharge, pain, etc.) will be assessed through weekly e-mail contact, followed up with telephone contact if there is no response to the e-mail. | Once a week during the 12 weeks of the study | 
| Changes in bladder neck height | Changes in bladder neck height will be assessed by Ultrasound imaging at baseline and after 12-weeks. The images will be recorded before and after a 30-minute running protocol on a treadmill. | 12 weeks | 
| Changes in levator hiatus area | Changes in levator hiatus area will be assessed by Ultrasound imaging at baseline and after 12-weeks. The images will be recorded before and after a 30-minute running protocol on a treadmill. | 12 weeks | 
| Changes in levator plate lenght | Changes in levator plate lenght will be assessed by Ultrasound imaging at baseline and after 12-weeks. The images will be recorded before and after a 30-minute running protocol on a treadmill. | 12 weeks | 
| Changes in pelvic floor muscle strength | Changes in pelvic floor muscle strength will be assessed at baseline and after 12-weeks using an intravaginal dynamometer. The measures will be recorded before and after a 30-minute running protocol on a treadmill. | 12 weeks | 
| Changes in pelvic floor muscle stiffness | Changes in pelvic floor muscle stiffness will be assessed at baseline and after 12-weeks using an intravaginal dynamometer. The measures will be recorded before and after a 30-minute running protocol on a treadmill. | 12 weeks | 
| Pad weight gain | Participants will be provided with a pre-weighed pad to attach to their underwear and wear it while running for 30 minutes on the treadmill. Once they finish running, the pad will be weighted again to record urine leakage. This will be done at the baseline and after 12-weeks. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise-induced urinary incontinence, running-induced urinary incontinence, intravaginal pessary, tampon, pelvic floor