Exploring Intravaginal Devices for Running-Related Urinary Leaks in Women: Study Overview

What is it about?

This study investigates the efficacy of intravaginal devices, such as the Uresta pessary and menstrual tampon, in mitigating exercise-induced urinary incontinence (UI) among female runners. Conducted as an assessor-blind randomized controlled trial, it aims to assess urine leakage during running, patient satisfaction, and symptom improvement over a 10-week intervention period. The trial includes 90 female participants who track their leakage for an initial 2 weeks, followed by random assignment to pessary, tampon, or control groups. Primary outcomes are measured through patient-reported impressions and satisfaction scales, while secondary outcomes include adherence and unintended effects. A subset of participants will undergo laboratory assessments to evaluate pelvic floor morphology and function, providing insights into potential mechanisms of intervention effectiveness. Results will contribute to understanding and improving conservative treatment options for exercise-induced UI in women. This study is registered under ClinicalTrials.gov identifier: NCT 05773378 and adheres to ethical research standards as per the Declaration of Helsinki.

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Why is it important?

This study investigates exercise-induced urinary incontinence (UI), a condition that particularly affects women engaging in high-impact physical activities. The research is significant because it addresses a common barrier to physical activity, which is crucial for reducing the global burden of lifestyle-related diseases. By exploring the effectiveness of intravaginal devices such as pessaries and tampons as potential conservative treatments, This study aims to provide accessible solutions for individuals with UI, thereby possibly enhancing their quality of life and ability to engage in regular exercise. Key Takeaways: 1. This study evaluates the effectiveness of intravaginal devices, specifically pessaries and menstrual tampons, in reducing symptoms of running-induced urinary incontinence over a 10-week intervention period. 2. The research employs a rigorous, assessor-blind randomized controlled trial design, with both primary and secondary outcomes to assess the frequency and amount of urine leakage, treatment satisfaction, and usability of the interventions. 3. This study includes an in-depth laboratory-based assessment of pelvic floor morphology and function to understand the mechanisms by which these interventions may be effective, providing a comprehensive analysis of their potential benefits.