Randomized Controlled Non-Inferiority Trial Comparing a Mobile Application Based Program With Conventional Rehabilitation for Stress and Mixed Urinary Incontinence in Adult Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn if a mobile app-guided pelvic floor rehabilitation program works as well as standard in-person pelvic floor rehabilitation to treat urinary leakage in adult women.
The main question it aims to answer is:
Does the app program improve quality of life related to urinary leakage as much as in-person rehabilitation?
Researchers will compare the app-based program to in-person rehabilitation to see if both lead to similar improvements in quality of life.
Participants will:
Attend one medical visit before starting to confirm they are eligible Attend one in-person training session with a physiotherapist Follow either an app-based or an in-person pelvic floor rehabilitation program for 3 months Complete quality of life questionnaires at the start and at 4 months
详细描述
Background
Urinary incontinence (UI) is common in women and undertreated in Portugal. Only 11% of Portuguese women with UI report having completed any rehabilitation program. Conventional pelvic floor rehabilitation requires supervised sessions two to three times per week for at least 3 to 4 months, mostly available only at tertiary hospitals. Mobile app-based programs may improve access, adherence, and convenience. However, no randomized trial has compared an app-based program directly against supervised rehabilitation as an active comparator in the Portuguese population. An important consideration in participant selection is pelvic floor muscle function. Studies show that up to 53% of women with UI cannot contract the pelvic floor correctly without prior in-person training. For this reason, the ability to voluntarily contract the pelvic floor is an inclusion criterion, confirmed at the baseline medical visit.
Study Design
This is a randomized controlled non-inferiority trial with two parallel arms conducted at the Pelvic Floor Rehabilitation Unit of the Physical and Rehabilitation Medicine (PM&R) Department of ULS São João, a tertiary academic hospital in Porto, Portugal.
The Mobile App
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
- None
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
- •age >18 years
- •stress urinary incontinence (SUI) or mixed urinary incontinence with predominance of SUI
- •more than one urinary incontinence episode for week in the last month
- •pelvic floor muscle strength equal or greater than 2 assessed by Oxford Modified Rating Score
排除标准
- •indwelling urinary catheter
- •active pelvic neoplasia
- •pelvic organ prolapse grade greater than or equal to 2
- •active urinary tract infection or macroscopic hematuria
- •neurogenic dysfunction of the lower urinary tract
- •cognitive deficit, osteoarticular, neurological or psychiatric pathologies that prevent the realization of the therapeutic program
- •conservative or surgical treatment of UI in the last 12 months
- •pregnancy or recent childbirth (< 6 months)
- •impossibility of access or illiteracy to technological means (smartphone)
- •unavailability to attend the supervised program due to accessibility, schedule or economic reasons
研究者
Susana Moreira
Principal investigator
Unidade Local de Saúde São João