跳至主要内容
临床试验/NCT02318251
NCT02318251Unknown不适用

Stress Urinary Incontinence Physiotherapy (SUIP) - A Randomized Controlled Trial With 6-Months Follow-up

Bern University of Applied Sciences2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

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

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

Experimental

Standard physiotherapy program (focus on involuntary reflexive pelvic floor muscle contractions)

干预措施: Involuntary muscle contractions (Other)

Voluntary muscle contractions

Active Comparator

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

发起方
Bern University of Applied Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lorenz Radlinger

Prof. Dr. Lorenz Radlinger

Bern University of Applied Sciences

研究点 (2)

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