[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498678":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":32,"centralContacts":36,"locations":45,"responsibleParty":69,"collaborators":23,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":23,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":23,"enrollmentInfo":81,"targetDuration":23,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":48,"whyStopped":23,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of Ottawa","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Pessary Intervention","EXPERIMENTAL","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.\n\nUresta 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.",[13],"Device: Pessary Intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[18],"Device: Tampon Intervention",{"label":20,"type":21,"description":22,"interventionNames":23},"Control Group","NO_INTERVENTION","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.",null,[25,29],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":23},"DEVICE","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.",[9],{"type":26,"name":15,"description":30,"armGroupLabels":31,"otherNames":23},"Participants will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 10-week period.",[15],[33],{"name":34,"affiliation":5,"role":35},"Linda McLean","PRINCIPAL_INVESTIGATOR",[37,42],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","613-562-5800","4102","lmclea2@uottawa.ca",{"name":43,"role":38,"phone":39,"phoneExt":40,"email":44},"Sabine Vesting","svesting@uottawa.ca",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"McLean Function Measurement Lab","RECRUITING","Ottawa","Ontario","K1S 1S2","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-75.69812,45.41117,{"lat":58,"lon":57},[61,65,68],{"name":62,"role":38,"phone":63,"phoneExt":40,"email":64},"Anne-Marie MacDonald, MSc","(613) 562-5800","mfmlab@uottawa.ca",{"name":66,"role":38,"phone":63,"phoneExt":67,"email":41},"Linda McLean, PhD","2544",{"name":66,"role":38,"phone":23,"phoneExt":23,"email":23},{"type":35,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Dr. Linda McLean","Professor in the School of Rehabilitation Sciences at University of Ottawa","100498678","do-intravaginal-devices-reduce-urinary-incontinence-in-female-runners-100498678",false,"NCT05773378","Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?","Do Intravaginal Devices Reduce or Eliminate Exercise Induced Urinary Incontinence in Female Runners?","Inclusion Criteria:\n\n* Females aged 18 years and over who run at least twice a week for a minimum of 10K\u002Fweek (minimum speed of 6 km\u002Fh 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\n* Who regularly (≥ 1 per week) experience urine leakage while running.\n\nExclusion Criteria:\n\n* Any risk factors related to exercise;\n* Pain or musculoskeletal injury at the time of the screening;\n* History of urogenital surgery;\n* Symptoms of the female athlete triad;\n* Have a known neurologic disorder (e.g. stroke, multiple sclerosis);\n* Pregnancy or partum within the previous year;\n\nFor the in-lab assessment:\n\n* Ability to run with a moderately full bladder for 38 minutes on a treadmill\n* BMI ≥ 30\n* Pelvic organ prolapse ≥ 2","FEMALE","18 Years",{"count":82,"type":83},90,"ESTIMATED","INTERVENTIONAL",[86],"NA","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.\n\nWhile 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.",[89],"Urinary Incontinence",[91,92,93,94,95],"exercise-induced urinary incontinence","running-induced urinary incontinence","intravaginal pessary","tampon","pelvic floor","2024-12-11",{"date":98,"type":99},"2024-12-17","ACTUAL",{"date":101,"type":99},"2023-04-14",{"date":103,"type":83},"2025-09-01",{"name":5,"class":6},1]