Usability, Acceptability and Effect of a Mobile Application and Connected Object for Older Women With Urinary Incontinence: a Mixed Method Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Percent change in the number of UI episodes
研究概览
简要总结
This project aims to evaluate the usability, acceptability, and impact of the Oups! mobile app and a connected Bluetooth dynamometer for at-home PFM training to treat UI. The study will:
- assess usability and participant feedback on the Oups! app, identifying improvements;
- evaluate the usability and acceptability of the dynamometer during assessment and home practice, noting potential enhancements; and
- measure the effects of the app and device on UI symptoms, quality of life, and PFM function post-treatment.
详细描述
CONTEXT:
Urinary incontinence (UI), or involuntary urine leakage, is a common issue among women over 55. Clinical guidelines recommend pelvic floor muscle (PFM) therapy as the first-line treatment for UI. However, fewer than one-third of older women seek treatment, often due to cost and accessibility barriers. Mobile applications have proven helpful in managing UI symptoms in younger women, offering a low-cost, private solution that encourages adherence. Although numerous apps exist, none are designed specifically for older women, nor have these women been consulted on app usability or effectiveness.
To address this, the investigators have developed the Oups! mobile app, based on our GROUP pelvic floor muscle training (PFMT) program for older women with UI. Additionally, the investigators propose using a connected device-a portable Bluetooth-enabled dynamometer-to measure PFM strength and contraction quality, supporting women in performing effective PFMT. Previously, our lab-developed Montreal Dynamometer provided this feedback but was limited to laboratory use.
This study will examine the usability, acceptability, and impact of combining the Oups! app with the new portable dynamometer for PFM self-training in women aged 55 and over. This innovative approach could potentially improve access to effective UI management and increase treatment uptake in this population.
METHODOLOGY:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •55 years +
- •Stress or mixed UI symptoms with predominantly stress UI symptoms
- •At least 3 or more urinary leaks/week
- •Able to ambulate safely
- •Understand simple instruction in French, written and verbally
- •Basic understanding of how to use a tablet or mobile phone
- •Willing to participate in a gynecological exam
- •Able to properly contract the PFM
- •Provide informed consent.
排除标准
- •Urge UI symptoms or mixed incontinence with primarily urgency
- •Neurological condition
- •Grade 3 or 4 of pelvic organ prolapse (POP)
- •Any other acute or chronic condition likely to interfere with the mobile app and/or connected object
- •Risk factors likely to interfere with the mobile app and/or connected object (i.e.: chronic constipation, chronic cough)
- •Medications that can interfere with the mobile app and/or connected object
- •Received UI treatments in the last year.
研究组 & 干预措施
Physiotherapy through mobile app and connected device
PFMT using the Oups! mobile app + a connected vaginal device for 12 weeks
干预措施: Physiotherapy through mobile app and connected device (Behavioral)
结局指标
主要结局
Percent change in the number of UI episodes
时间窗: at recruitment and 13 weeks after recruitment
evaluated with a 7-day bladder diary
次要结局
- Change in the symptoms and the degree to which UI-associated symptoms are troubling or bothersome(at recruitment and 13 weeks after recruitment)
- Change in UI related QOL(at recruitment and 13 weeks after recruitment)
- Change in PFM function: PERFECT Score(at recruitment and 13 weeks after recruitment)
- Change in PFM Function: Montreal Dynamometer(at recruitment and 13 weeks after recruitment)
- Change in Pelvic Floor Muscle Function: Connected Device(at recruitment and 13 weeks after recruitment)
- Severity of a pelvic organ prolapse: Baden-Walker System(at recruitment and 13 weeks after recruitment)
- Severity of a pelvic organ prolapse: Simplified Pelvic Organ Prolapse Quantification(at recruitment and 13 weeks after recruitment)
- Adherence to intervention: Frequency of exercise days(during the 12-week intervention)
- Participant engagement: Educational and motivational video completion rate(during the 12-week intervention)
- Training intensity: average force produced during exercises(during the 12-week intervention)
- Acceptability of the Mobile App and Connected Device: uMARS Score(13 weeks after recruitment)
- Participant Experience and Acceptability: Qualitative Interviews(13 weeks after recruitment)
研究者
Chantal Dumoulin
Dr Chantal Dumoulin, researcher and laboratory director
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal