The Effectiveness of a Tele-rehabilitation Program Implemented in a Greek Clinical Setting for Women With Urinary Incontinence: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1-hour Pad test
研究概览
简要总结
The prevalence of urinary incontinence (UI) in the female Greek population is 1 to 3 women (27%).Globally, the development of tele-rehabilitation programs through mobile application (mobile apps) has been a breakthrough for UI treatment. More specifically, the pelvic floor muscles (PFM) exercise programs through mobile apps, provide optimal health care services by offering to the patients a therapy program in the convenient environment of their choice (e.g their homes), with safety and less expense. Furthermore, it is given the opportunity to patients with mobility problems or with lack of transport or to them who live in remote areas, to treat their incontinence.
However, the majority of the existence mobile apps, work as simple verbal instructions and they do not being tailored in patients' individual needs, which is necessary for the successful implementation of the PFM exercise programs. Additionally, the PFM training is effective for UI treatment, when occurs intensively (daily) with supervision for at least 3 months by a physiotherapist. However, the adherence to a such intensive treatment program is very often compromised, because of many reasons (e.g lack of interest etc).
Therefore the main purpose of the current study is, to investigate the effectiveness of a tele-rehabilitation program, through a novel, innovative mobile app (customized in patients needs), in cooperation with a PFM superficial sensor. The mobile app will offer an interactive environment and the opportunity of a simultaneous supervision by a physiotherapist during the treatment, which might provide sufficient motivation to the patient to adhere with the intensive PFM exercise program. A secondary objective of the study is, to investigate the degree of adherence to PFM exercises and the degree of supervision, which is needed in the tele-rehabilitation program. Both the mobile app and the PFM superficial sensor, will be created for the needs of the present study.
详细描述
The present study is designed to be conducted as a prospective randomized controlled clinical trial (RCT) with three arms.
- The Telerehabilitation Group (TeleG) will use the mobile app in collaboration with the pelvic floor muscle (PFM) superficial sensor, with the remote supervision of the physiotherapist, which will take place in home.
- Traditional treatment Group (TrG) will follow PFM exercises program with the physiotherapist, which will take place in a health care environment.
- Control Group (CG) will execute the PFM exercises via a home leaflet, without any supervision.
Αll patients will be assessed in three sessions, at baseline (0 wk), half-way at 6 wks and at the end of the treatment (after 12 wks).
Primary outcome measures will evaluate the severity of the incontinence and the quantity of the urinary loss through the patient-centered International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF) and the clinician-centered '1-hour Pad test', respectively.
Secondary outcomes will include vaginal evaluation through (a) digital palpation using the PERFECT assessment scheme and through (b) an electromyography probe, in order to be assessed the power and the endurance of the PFMs. The patients will complete patient-centered outcome measures, such as a specific PFM exercise adherence questionnaire and a PFM exercise diary during their treatment, in order to be evaluated on how well they followed the program.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The randomization list will remain hidden from the responsible physical therapist who will implement the treatment in the groups (he/she will be informed on the first day of the intervention for each patient). Due to the nature of the treatment, the intervention is not blinded between participants and clinicians. However, the analysis of the data will be 'blind' to all both parties, assessor and investigator.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Greek women,
- •18-75 years old,
- •Diagnosis of SUI or mixed UI (via Urodynamic test).
- •Writing and reading of the Greek language
- •Usage of 'smartphones' and internet,
- •Able to perform a voluntary muscle contraction of the PFM, during the clinical examination.
排除标准
- •6 months after postpartum,
- •Systemic diseases,
- •Malignancy,
- •Major gynecological surgery (i.e. total hysterectomy) over the last 10 years,
- •Neurological dysfunction,
- •Mental impairment
结局指标
主要结局
1-hour Pad test
时间窗: At baseline (0 week) and at the end of the intervention (12 weeks)
Clinician-centered test by which, the pad is weighed before and after a set of specific-standardized exercises (walking, general exercises, etc.) during one hour. It is compared the difference in the amount of urine retained before and after the exercises in the pad, in order to de determined the urine leakage of the patient.Τhe 1-hour Pad test is given in three scoring categories: (a) mild incontinence (\<10 ml) , (b) moderate incontinence (11-50ml) and (c) severe incontinence (\>50 ml)
International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF)
时间窗: At baseline (0 week), in the middle (6 weeks), and at the end of the intervention (12 weeks)
Patient-centered questionnaire which contains questions that assess the frequency, severity, and impact of incontinence on patients. The ICIQ-UI SF (range 0-21) is given in four scoring categories: (a) slight symptoms (1-5), (b) moderate symptoms (6-12), (c) severe symptoms (13-18) and (d) very severe symptoms (19-21).
次要结局
- Patient Global Impression of Improvement (PGI-I Scale)(At the end of the intervention (12 weeks))
- PERFECT assessment scheme(At baseline (0 week), in the middle (6 weeks), and at the end of the intervention (12 weeks))
- Australian Pelvic Floor Questionnaire (APFQ)(At baseline (0 week), and at the end of the intervention (12 weeks))
- Electromyographic (EMG) PFM's activity(At baseline (0 week), in the middle (6 weeks), and at the end of the intervention (12 weeks))
- PFM adherence exercise diary(At baseline (0 week) is provided the PFM adherence exercise diary and the patients will return it, at the end (12 weeks) of the intervention)
- Adherence questionnaire(At the middle (6 weeks), and at the end of the intervention (12 weeks))
研究者
Evdokia Billis
Professor in Physiotherapy
University of Patras