Intravaginal devices for running-induced urinary incontinence symptoms in females: a study protocol

Background

Exercise-induced urinary incontinence (UI) can hinder physical activity, particularly in women engaging in high-impact activities. This condition is linked to reduced passive support of the urethra and bladder. Intravaginal devices that support pelvic structures may offer a solution, but high-quality evidence is lacking.

Study Design

The study is an assessor-blind randomised controlled trial.

Primary and Secondary Endpoints

Primary outcomes include frequency and amount of urine leakage during running over a 2-week period, Patient Global Impression of Improvement, treatment satisfaction, and the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, measured at baseline and after a 10-week intervention. Secondary outcomes include adherence and unintended effects. A subset of participants will be invited to a laboratory-based assessment at baseline and follow-up involving pelvic floor morphometry and function to explore the mechanisms through which the interventions may be effective.

Patients and Methods

We aim to recruit 90 runners aged ≥18 years, with female-typical pelvic anatomy, who report running-induced UI. After 2 weeks of leakage tracking without any intervention, participants will be randomly assigned to a 10-week pessary, tampon, or control intervention (1:1:1 ratio). Follow-up assessments will be performed at 11–12 and 16 weeks. Between- and within-group differences will be evaluated with general linear models using an intent-to-treat approach.

Trial Registration and Ethics

This study is registered (ClinicalTrials.gov identifier: NCT 05773378), has been approved by the local Institutional Research Ethics Board, and follows the Declaration of Helsinki. Results will be published in peer-reviewed journals, shared with clinicians and participants, and disseminated publicly.