Study of Intravaginal Devices to Reduce Urinary Leakage During Running in Adult Female Runners

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.

Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?