Do Intravaginal Devices Reduce or Eliminate Exercise Induced Urinary Incontinence in Female Runners?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Urinary leakage tracking: Proportion of training sessions during which urine leakage occurred
研究概览
简要总结
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.
详细描述
Urinary incontinence (UI) is a serious public health concern, imposing a significant financial burden. In Canada the direct and indirect health costs associated with UI total over 3.6 billion annually and no estimates of disease burden take into account deconditioning that results from withdrawal from physical activity nor effects on mental health or quality of life. Although the primary risk factor for UI is pregnancy and vaginal delivery, it was recently reported that between 20% and 40% of nulliparous females report urine leakage when they engage in physical activity.
Urinary continence is maintained as long as urethral closure pressure remains higher than bladder pressure. This is accomplished through a complex combination of mechanisms, including smooth and striated urethral sphincter muscle action, urethral venous engorgement and mucous secretions within the urethra, and the proper transfer of loads to the urethra, which depends on adequate bladder neck and urethral connective tissue support as well as pelvic floor muscle (PFM) action. The associations among physical activity, pelvic floor morphology and function, and UI are not clear. A recent systematic review retrieved 18 mainly small studies investigating the association between physical activity and pelvic floor dysfunction. Exercise at mild to moderate intensity appears to be protective, decreasing both the odds and the risk of experiencing urinary incontinence. However, females who engage in high-impact activities such as running are more likely to report UI during exercise than those who engage in mild or moderate intensity exercise, thus chronic and repetitive loading of the pelvic floor may have negative consequences.
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 investigated about interventions specific to running-induced UI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 18 years and over who run at least twice a week for a minimum of 10K/week (minimum speed of 6 km/h to ensure high impact), who have done so for at least 6 months (to ensure adequate duration of exposure), and who commit to continue the same amount during the study period
- •Who regularly (≥ 1 per week) experience urine leakage while running.
排除标准
- •Any risk factors related to exercise;
- •Pain or musculoskeletal injury at the time of the screening;
- •History of urogenital surgery;
- •Symptoms of the female athlete triad;
- •Have a known neurologic disorder (e.g. stroke, multiple sclerosis);
- •Pregnancy or partum within the previous year;
- •For the in-lab assessment:
- •Ability to run with a moderately full bladder for 38 minutes on a treadmill
- •Pelvic organ prolapse ≥ 2
结局指标
主要结局
Urinary leakage tracking: Proportion of training sessions during which urine leakage occurred
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Intervention questionnaire(Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks)
- Adherence to each intervention(Once a week during the 12 weeks of the study)
- Unintended effects(Once a week during the 12 weeks of the study)
- Brisk walking and Running lower Urinary Tract Symptoms Questionnaire (BRUTS) score(Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks)
- Changes in bladder neck height(Baseline and post intervention (at 12 weeks))
- Changes in levator hiatus area(Baseline and post intervention (at 12 weeks))
- Changes in levator plate length(Baseline and post intervention ( at 12 weeks))
- Changes in pelvic floor muscle strength(Baseline and post intervention ( at 12 weeks))
- Changes in pelvic floor muscle stiffness(Baseline and post intervention ( at 12 weeks))
- Pad weight gain(Baseline and post intervention ( at 12 weeks))
研究者
Dr. Linda McLean
Professor in the School of Rehabilitation Sciences at University of Ottawa
University of Ottawa