Intravaginal devices for running‐induced urinary incontinence symptoms in females: a study protocol
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Wiley Open Access
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| Natura: | Artículo Open Access |
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Wiley
2025
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| author | Sabine Vesting Marina Petter Rodrigues Grace Collins Linda McLean |
| author_facet | Sabine Vesting Marina Petter Rodrigues Grace Collins Linda McLean Sabine Vesting Marina Petter Rodrigues Grace Collins Linda McLean |
| collection | Wiley Open Access |
| contents | Intravaginal devices for running‐induced urinary incontinence symptoms in females: a study protocol Sabine Vesting Marina Petter Rodrigues Grace Collins Linda McLean BJU International 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. 10.1111/bju.16708 http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| doi_str_mv | 10.1111/bju.16708 |
| format | Artículo Open Access |
| id | wiley_oa_10_1111_bju_16708 |
| institution | Wiley Open Access |
| license_str_mv | http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| publishDate | 2025 |
| publisher | Wiley |
| record_format | wiley_oa |
| spellingShingle | Intravaginal devices for running‐induced urinary incontinence symptoms in females: a study protocol Sabine Vesting Marina Petter Rodrigues Grace Collins Linda McLean BJU International Intravaginal devices for running‐induced urinary incontinence symptoms in females: a study protocol Sabine Vesting Marina Petter Rodrigues Grace Collins Linda McLean BJU International 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. 10.1111/bju.16708 http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| title | Intravaginal devices for running‐induced urinary incontinence symptoms in females: a study protocol |
| topic | BJU International |
| url | https://bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.16708 |