Effects of Home-based Telerehabilitation-assisted High-intensity Inspiratory Muscle Training on Pelvic Floor Muscle Function and Urinary Symptoms in Women With Stress Urinary Incontinence: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change of Pelvic floor muscle functions with Pressure feedbacks
研究概览
简要总结
Strengthening the diaphragm muscle, the roof of the pelvic floor muscles (PFM), may be an alternative intervention in patients suffering from stress urinary incontinence (SUI). This study aims to investigate the effects of home-based telerehabilitation-assisted high-intensity inspiratory muscle training (IMT) on PFM function and urinary symptoms in women with SUI.
详细描述
The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30 breaths with a 1-minute rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The IMT was performed twice a day, 7 days/week, for 8 weeks. The study group performed IMT at 60% of their baseline MIP and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session, while the control group performed a sham-IMT without applied resistance. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.
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 (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with stress urinary incontinence by a specialized Urologist
- •Being female aged between 25 and 50 years
- •To have the ability to access and use technological devices required by the study
- •Being able to read and write
- •Volunteering to research
排除标准
- •Inability of the participant to understand or perform the procedures proposed during the evaluations or training program.
- •Active urinary tract infection,
- •pelvic organ prolapse stage 2 and more according to the pelvic organ prolapse staging system (Pelvic Organ Prolapse Quantification System (POP-Q))
- •Fecal incontinence,
- •Any neurogenic dysfunction of the lower urinary tract
- •Conservative or surgical treatment of urinary incontinence in the last 12 months
- •Previous pelvic floor training
- •Less than three months after pregnancy or postpartum
- •Having undergone any pelvic floor surgery (hysterectomy, etc.)
- •Radiotherapy treatment in the last 12 months
- •Severe low back pain or pelvic pain
- •Lower extremity orthopaedic problems that may affect the pelvic structure (such as lower extremity inequality, total hip arthroplasty)
- •Having any chronic respiratory disease
- •Having any neurological disease
- •Being in menopause
- •Latex allergy
研究组 & 干预措施
Study Group
Patients who perform inspiratory muscle training (IMT) with %60 loading
干预措施: Inspiratory Muscle Training (IMT) (Device)
Sham Group
Patients who perform Sham IMT
干预措施: Sham IMT (Device)
结局指标
主要结局
Change of Pelvic floor muscle functions with Pressure feedbacks
时间窗: 8 weeks
Pressure feedbacks: Pelvic muscle functions were evaluated with pressure feedback of pelvic muscle using a biofeedback device (Myomed 932®- Enraf-Nonius, Delf, The Netherlands), and recorded in hPa (Hectopascal). - Manual muscle test: Manual muscle test was evaluated using the modified Oxford Scale that ranges from 1 to 5. Higher values on this scale indicate better muscle strength.
Change of Pelvic floor muscle functions with Manual muscle test
时间窗: 8 weeks
The manual muscle test was evaluated using the modified Oxford Scale, which ranges from 1 to 5. Higher values on this scale indicate better muscle strength.
次要结局
- Urogenital Distress Inventory-Short Form(8 weeks)
- International Consultation on Incontinence Questionnaire-Short Form(8 weeks)
- Incontinence Severity Index(8 weeks)
- Inspiratory muscle strength(8 weeks)
研究者
Ridvan Aktan
Asst. Prof., PhD
Izmir University of Economics