Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?

Condition(s) studied

Investigational drug(s) / intervention(s)

Pessary Intervention: Participants will receive a 3-size fitting kit and will fit the appropriate size based on manufacturer instruction. Once the size is verified, the participants will be asked to use the pessary while running over a 10-week period.

Tampon Intervention: Participants will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 10-week period.

Study summary

More than one in five females experience the embarrassment and shame of urine leakage while exercising and this urinary incontinence (UI) is a substantial barrier to exercise. As many as one in three females with UI report that they limit their physical activity due to incontinence: 11.6% by not exercising at all, 11.3% by exercising less and 12.4% by changing the type of exercise they perform. It is imperative to look for alternatives to manage this condition, as it is a key reason why females abandon the very physical exercise that is necessary to maintain or improve their physical and mental health and their quality of life.

While there is Grade A evidence for pelvic floor muscle training and some evidence for intravaginal pessaries to reduce symptoms of UI in general female populations, no study has evaluated the impact of conservative interventions specifically on UI experienced predominantly during running.

Eligibility

Primary outcome measure(s)

• Urinary leakage tracking: Proportion of training sessions during which urine leakage occurred — at baseline, and during intervention week 10-12
  At baseline, participants will be asked to complete a bladder diary, recording leakage experiences during each running session over a two-week period, while running without any intervention. This tracking will be repeated for another two-week period starting in the eighth week of running with the intervention (weeks 10-12 of the protocol). Participants will receive daily reminders to fill it out.
• Patient's global impression of improvement — Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
  Participants will be asked to rate their overall impression of symptom improvement over the 10-week intervention on a 7 step scale (7= very much worse, to 1= very much better). Also, a follow-up will be conducted upon finishing the intervention, and, if they are still using the intervention, participants will be invited to rate their overall impression again at 16, 24 and 36 weeks.
• Patient's global satisfaction with treatment — Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
  The participants will be asked how satisfied they were with their progress during the 10-weeks, on a scale from 0 to 100% (0 = not at all satisfied, 100 = completely satisfied). Also, a follow-up will be conducted upon finishing the intervention, and, if they are still using the intervention, participants will be invited to rate their satisfaction again at 16, 24 and 36 weeks.
• International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) — Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
  The ICIQ-FLUTS is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life in research and clinical practice, with validity, reliability and responsiveness established with rigour in several data sets. It has a total of 12 questions; four questions on filling symptoms, three on voiding symptoms and five questions on urinary incontinence symptoms. The overall score ranges from 0-48, where all subscales scores are added. Higher scores indicate greater impact of individual symptoms for the patient. Participants will be asked to complete it at baseline and after 12-weeks. Also, a follow-up will be conducted upon finishing the intervention, and participants will be invited to complete the questionnaire again at 16, 24 and 36 weeks.
• International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) — Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
  The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a questionnaire that includes three questions about urinary incontinence frequency, severity, and impact on daily life, resulting in a score of 0-21. The fourth question aims to classify the type of urinary incontinence, for this study 'leaks when you are physically active/exercising.' The questionnaire has a Level A validation grade according to ICI standards, as its validity, reliability, and responsiveness have been tested in several data sets. Participants will be asked to complete it at baseline and after 12-weeks. Also, a follow-up will be conducted upon finishing the intervention, and participants will be invited to complete the questionnaire again at 16, 24 and 36 weeks.

Trial sites (1)

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