The Feasibility and Effects of a Telehealth-delivered Physical Therapy Program for Postmenopausal Women with Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Satisfaction scale
研究概览
简要总结
Postmenopausal women frequently report physical (hot flushes, night sweat, insomnia, vaginal dryness, sexual dysfunction, urinary incontinence, reduced fitness level, osteoporotic symptoms, sarcopenia, decreased fat free mass, etc.) and psychological (depression, anxiety, cognitive decline, etc.) symptoms. Among these symptoms, urinary incontinence is one of the most common manifestations of pelvic floor dysfunction and may significantly impact on women's quality of life. Urinary incontinence is highly prevalent (30%) in postmenopausal women and is primarily attributed to the decreased level of estrogen. Other potential risk factors for urinary incontinence after menopause include age, parity, genetic factors, pregnancy, overweight/obesity, low physical activity levels, diabetes, urinary tract infection, etc. International guidelines recommend lifestyle and behavioral change, pelvic floor muscle training and bladder training as first-line treatments for urinary incontinence in postmenopausal women. During the COVID-19 pandemic, access to and utilization of healthcare services is reduced. As travel distance has been reported as one of the strong barriers to healthcare among patients with incontinence, research has been conducted to investigate the applications and effects of telehealth. While telehealth rehabilitation may improve urinary incontinence symptoms, the field is still emerging and more studies are needed to elucidate how physical therapists can perform telehealth pelvic floor muscle training for urinary incontinence.
The objectives of this three-year study are:
- to investigate the feasibility of a telehealth-delivered physical therapy program for postmenopausal women with urinary incontinence
- to explore the effects of a telehealth-delivered physical therapy program on urinary incontinence symptoms, pelvic floor muscle function and quality of life in postmenopausal women with urinary incontinence
- to compare the effectiveness of telehealth physical therapy program with face-to-face physical therapy in this population
- to compare body composition, physical activity levels, functional capacity, grip strength, urinary incontinence symptoms, and pelvic floor muscles function in women at early versus late stage of post-menopause
- to evaluate the relationships between duration after menopause and body composition, physical activity levels, functional capacity, grip strength, urinary incontinence symptoms, and pelvic floor muscles function
详细描述
This is a non-inferiority randomized controlled trial with a nested cross-sectional study and a nested qualitative interview study. Sixty community-dwelling postmenopausal women with urinary incontinence, aged >40 years, will be recruited and randomly allocated to two groups, telehealth group or face-to-face group. All groups will receive a 12-week pelvic floor muscle training. The face-to-face group will be supervised by a female physical therapist who will provide pelvic floor muscle training twice a week. The training will be adjusted according to the performance of the participant. The telehealth group will receive eight sessions of individualized pelvic floor muscle training provided by a physical therapist via telehealth in addition to a weekly telephone coaching. The baseline, post-intervention, and 3-month follow-up assessments will include feasibility outcomes, measurements of anthropometry, body composition (body composition monitor), hand grip strength (dynamometer), functional exercise capacity (six minute walk test), and pelvic floor muscle function (vaginal manometry, transperineal ultrasound and digital palpation) and two questionnaires about symptom severity of urinary incontinence and physical activity levels. This study will provide evidence of effectiveness of different delivery modes of physical therapy program for postmenopausal women with urinary incontinence and health-care professionals working with this population in clinical practice.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged over 40 years
- •postmenopausal women: amenorrhea for longer than 12 months
- •having symptomatic UI (defined as having the Questionnaire for Urinary Incontinence Diagnosis score > 0 point)
- •being able to answer the questionnaire correctly (no language barrier or cognitive problems)
- •having no other physical or psychological problem that would interfere participation in the study
- •having access to a mobile video conference device with internet access
排除标准
- •women aged over 85 years old
- •receiving hormone therapy
- •having neurological conditions, malignancy for pelvic organ, overflow incontinence or voiding dysfunction
- •had received radical surgery for pelvis, sling or prolapse surgery
结局指标
主要结局
Satisfaction scale
时间窗: absolute values at 12 weeks
Satisfaction will be was assessed using a five-point Likert-scale ranging from '1 = very dissatisfied' to '5 = very satisfied'.
Number of intervention sessions attended
时间窗: absolute values at 12 weeks
Attendance rate: number of sessions attended will be divided by the total number of expected sessions within each treatment arm
Number of participants consented to participate
时间窗: absolute values at baseline
Consent rate: number of participants enrolled will be divided by number of eligible patients approached
Number of completed training sessions in relation to the scheduled sessions
时间窗: absolute values at 12 weeks
Adherence rate: the total number of exercise sessions completed as a proportion of that prescribed each week from baseline to 12 week.
Number of participants with intervention-related adverse events as assessed by CTCAE v4.0
时间窗: absolute values at 12 weeks
Adverse events: the number of adverse or serious adverse events throughout the 12-week intervention period. Participants will be asked about any symptoms (such as pain, bleeding or itching) at each training session.
Number of participants who remain in the study 3 months after baseline assessment
时间窗: absolute values at 3 months
Retention rate: number of participants who remain in the study at 3-month follow-up as a proportion of the total number of participants recruited at the baseline assessment
Number of participants who withdrew from the trial
时间窗: absolute values at 12 weeks and 3 months
Withdrawal rate: number of participants who withdraw from the trial after consenting divided by the number of participants who initially consent to the trial
Acceptability scale
时间窗: absolute values at 12 weeks
Acceptability will be was assessed using a five-point Likert-scale ranging from '1 = very dissatisfied' to '5 = very satisfied'.
次要结局
- Weight(absolute values at 12 weeks and 3 months)
- Body mass index(absolute values at 12 weeks and 3 months)
- Anorectal angle(absolute values at 12 weeks and 3 months)
- Physical activity levels(absolute values at 12 weeks and 3 months)
- Height(absolute values at 12 weeks and 3 months)
- Severity of urinary incontinence(absolute values at 12 weeks and 3 months)
- Handgrip strength(absolute values at 12 weeks and 3 months)
- Pelvic floor muscle strength(absolute values at 12 weeks and 3 months)
- Bladder neck descent(absolute values at 12 weeks and 3 months)
- Body fat percentage(absolute values at 12 weeks and 3 months)
- Skeletal muscle percentage(absolute values at 12 weeks and 3 months)
- Functional exercise capacity(absolute values at 12 weeks and 3 months)
- Visceral fat level(absolute values at 12 weeks and 3 months)
- Anteroposterior diameter of the urogenital levator hiatus(absolute values at 12 weeks and 3 months)
研究者
Kuan-Yin Lin
Assistant Professor
National Taiwan University