Intravaginal devices for running‐induced urinary incontinence symptoms in females: a study protocol
Bibliographic record
Abstract
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: NCT05773378), 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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.016 | 0.011 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.007 | 0.004 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.004 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.006 | 0.005 |
| Insufficient payload (model declined to judge) | 0.056 | 0.012 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".