Comparison Between a Telerehabilitation Program for Urinary Incontinence Versus a Conventional Face-to-face Program: a Longitudinal Study in Pandemic Times
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Assessment of urinary incontinence related quality of life using the Portuguese Version of the King's Health Questionnaire (KHQ).
研究概览
简要总结
Urinary incontinence (UI) is defined as any involuntary loss of urine. It affects a significant percentage of the population, mainly female, with a prevalence of 21.4% in Portuguese women, having a negative impact on quality of life and sexual function.
About half presents with stress UI (SUI), followed by mixed UI (MUI), with isolated urgency UI being less common.
Pelvic floor rehabilitiation is a first line treatment for SUI and MUI, however, it is not yet defined which is the best treatment program or the ideal strategies to improve adherence to it.
Telerehabilitation assumed a leading role in the covid pandemic phase, although there are few studies on pelvic floor rehabilitation for UI, none in Portugal to date.
The authors aim to evaluate the effectiveness of a hybrid program of pelvic floor rehabilitation in female patients with SUI and MUI with a predominance of SUI, including consultation and face-to-face sessions complemented with telerehabilitation.
详细描述
Randomized longitudinal study including consecutively admitted patients on pelvic floor rehabilitation consultation of the Physical Medicine and Rehabilitation Department of Centro Hospitalar São João for conservative treatment of UI.
Patients who meet the inclusion criteria and do not meet any of the exclusion criteria will be randomized one to one between the intervention group and the control group.
The intervention group includes a hybrid program of face-to-face sessions followed by sessions of video, while the control group develops the entire program in face-to-face sessions.
The effectiveness of the program will be assessed by the results in the UI-related quality of life (primary outcome); UI severity, patient's overall perception of improvement, sexual function, depression/anxiety symptoms and satisfaction and adherence to treatment (secondary outcomes).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged between 18 and 65 years with SUI or MUI with a predominance of SUI with at least 1 urinary incontinence episode per week in the last month
- •Pelvic floor muscle strength greater than or equal to 2 (modified Oxford scale)
- •Capable of understanding and executing the therapeutic program and expressing agreement to participate in the study after free and informed consent
排除标准
- •Patients with urgency urinary incontinence or MUI with a predominance of urgency
- •Pregnant women
- •Submitted to conservative or surgical treatment of UI in the last 12 months
- •Active urinary tract infection
- •Macroscopic hematuria
- •Neurogenic dysfunction of the lower urinary tract
- •Cognitive deficit
- •Osteoarticular, neurological or psychiatric pathologies that prevent the realization of the therapeutic program
- •Active pelvic neoplasia
- •Pelvic organ prolapse grade greater than or equal to 2
- •Impossibility of access or illiteracy to technological means (phone or computer)
- •Unavailable to attend the face-to-face program due to accessibility, schedule, economic reasons or fear of the pandemic context
结局指标
主要结局
Assessment of urinary incontinence related quality of life using the Portuguese Version of the King's Health Questionnaire (KHQ).
时间窗: From admission to discharge of the program, up to 13 weeks.
The primary outcome is the assessment of urinary incontinence related quality of life using the Portuguese Version of KHQ.
次要结局
- Assessment of UI severity.(From admission to discharge of the program, up to 16 weeks.)
- Evaluation of the global perception of improvement of the patient.(From admission to discharge of the program, up to 13 weeks.)
- Evaluation of sexual function.(From admission to discharge of the program, up to 13 weeks.)
- Assessment of the presence of symptoms of depression/anxiety.(From admission to discharge of the program, up to 13 weeks.)
- Assessment of satisfaction with the treatment.(From admission to discharge of the program, up to 13 weeks.)
- Assessment of adherence to the treatment.(From admission to discharge of the program, up to 13 weeks.)
研究者
Susana Moreira
Medical Doctor
Centro Hospitalar De São João, E.P.E.