Stress Urinary Incontinence Physiotherapy (SUIP) - A Randomized Controlled Trial With 6-Months Follow-up
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))
研究概览
简要总结
The purpose of the present study is to compare two different physiotherapy programs regarding their effect on stress urinary incontinence.
详细描述
Stress urinary incontinence (SUI), the most prevalent type of urinary incontinence, is defined as involuntary loss of urine during effort, or physical exertion (e.g. sporting activities), or upon sneezing, or coughing (Haylen et al, 2010). The overall prevalence of stress, urge, mixed, and any UI was 23.7%, 9.9%, 14.5%, and 49.2%, respectively (Minassian et al, 2008).
Numerous epidemiologic studies show that parity is a risk factor for SUI. Other significant risk factors are age, weight, obesity, chronic pulmonary diseases, ethnic background, and menopause. (Minassian et al, 2008; Matthews et al, 2013) Urinary incontinence affects four times more women (51.1%) than men (13.9%) (Markland et al, 2011). It has an impact on the physical, psychosocial, social, personal, and economic well-being of the affected individuals and of their families. It is associated with a concomitant impairment of activities and participation, and a higher risk of suffering from anxiety disorders has been shown. (Goldstick & Constantini, 2014; Hunskaar et al, 2003).
SUI is increasingly recognized as a health and economic problem, which not only troubles the affected women, but also implies a substantial economic burden on the health and social services (Hampel et al, 2004).
Consequently, as physiotherapy has proven to be good value for the money, its effectiveness could contribute to a reduction in the cost of health care.
Pelvic floor muscles (PFM) have to be able to contract strongly (Shishido et al, 2008), rapidly and reflexively (Deffieux et al; 2008; Morin et al, 2004) to guarantee continence. The ability of PFM to generate rapid and strong contractions results in the generation of an adequate squeeze pressure in the proximal urethra, which maintains a pressure higher than that in the bladder, thus preventing leakage (Miller et al, 1994). Rapid and reflexive PFM contractions are crucial for maintaining continence, preceding an abrupt rise in the intra-abdominal pressure associated with coughing, sneezing, running, or jumping (Morin et al., 2004). Studies have shown that the PFM function regarding power (rate of force development) was impaired in incontinent women compared to continent women (Deffieux et al, 2008; Morin et al, 2004).
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
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •Stress urinary incontinence (based on the patient's history)
- •Mixed incontinence (with dominant SUI)
- •1 year post-partal, parous, nulliparous, pre- or post-menopausal
- •BMI 18-30
- •Participants must be medically and physically fit for the exercises (running, jumps)
- •Stable on systemic or local estrogen treatment for the past 3 months prior to inclusion
排除标准
- •Urge incontinence or predominant urgency in incontinence
- •Prolapse > grade 1 POP-Q (Bump et al., 1996) (uterus, cystocele, rectocele during Valsalva maneuver)
- •Pregnancy (test to accomplish)
- •Current urinary tract or vaginal infection
- •Menstruation on the day of examination
- •Lactation period not yet finished
- •Contraindications for measurements, e.g. acute inflammatory or infectious disease, tumor, fracture
- •De novo systemic or local estrogen treatment (< 3 months)
- •De novo drug treatment with anticholinergics or other bladder active substances (tricyclic antidepressants, Selective Serotonin Reuptake Inhibitor etc.)
研究组 & 干预措施
Involuntary muscle contractions
Standard physiotherapy program (focus on involuntary reflexive pelvic floor muscle contractions)
干预措施: Involuntary muscle contractions (Other)
Voluntary muscle contractions
Physiotherapy program (focus on voluntary pelvic floor muscle contractions)
干预措施: Voluntary muscle contractions (Other)
结局指标
主要结局
International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))
时间窗: up to 6 months follow up
The ICIQ-UIsf provides a brief and robust measure to assess the impact of symptoms of incontinence on quality of life and outcome of treatment
次要结局
- International Consultation on Incontinence Modular Questionnaire - Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)(up to 6 months follow up)
- International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))(At the 6 months follow up)
- Pelvic floor muscle electromyography(up to 6 months follow up)
- 20-minute PAD-test(up to 6 months follow up)
研究者
Lorenz Radlinger
Prof. Dr. Lorenz Radlinger
Bern University of Applied Sciences
