Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet Prior to Bariatric Surgery: an Assessor Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Self report of urinary incontinence by women
研究概览
简要总结
The purpose of this study is to assess the efficacy of pelvic floor muscle training (PFMT) on urinary incontinence reports in obese women undergoing a low calorie diet prior to bariatric surgery for obesity. The study will also assess and compare rates of adherence to treatments, pelvic floor muscle function and women´s self perception of their PFM function, and satisfaction with treatment.
详细描述
According to the World Health Organization (WHO), the adult overweight rate in 2014 reached 20%, with the highest prevalence among women. In addition to metabolic diseases, obesity can cause musculoskeletal disorders, including pelvic floor muscle (PFM) disorders and urinary incontinence (UI) is the most prevalent one. Conservative intervention can be medication, lifestyle changes, but pelvic floor muscle training (PFMT) is considered the first-line conservative therapy for urinary incontinence in women and it is effective when delivered both individually or in group.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The principal investigator will be blind in relation to group allocation and the outcome assessor will be blind too in relation to group allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients of the outpatient bariatric surgery service that will start a low calorie diet program as part of the bariatric presurgery routine of the service
- •Over 18 years old
- •With body mass index greater than 30kg / m2
- •Who have reported urinary incontinence in the last four weeks
- •Who have the ability to contract the pelvic floor muscles
- •No report of neurological disease, no cognitive impairment
- •That are not pregnant.
排除标准
- •Women who do not wish to continue participating in the research.
结局指标
主要结局
Self report of urinary incontinence by women
时间窗: Women will be evaluated at baseline
Self report of urinary incontinence measured using question 3 of the ICIQ-SF. Women will be considered incontinent if they choose option 1,2,3,4,5 of question 3. Women will be considered continent if they choose option 0 of question 3.
Severity and impact of Urinary incontinence in women´s quality of life
时间窗: Women will be evaluated at baseline
the severity and impact of Urinary incontinence in women´s quality of life will be measured using the ICIQ-SF score
次要结局
- participants self-perception of their PFM function(Women will be evaluated at baseline)
- Satisfaction with treatment(only after 12 weeks from the baseline assessment)
- Participants' adherence to the PFMT protocol(Women will be evaluated at baseline and right after 12 weeks)
- PFM function(Women will be evaluated at baseline)
- Identification of barriers for the treatment(only after 12 weeks from the baseline assessment)
- Subjective satisfaction with treatment(only after 12 weeks from the baseline assessment)
研究者
Pauliana Carolina de Souza Mendes
Physiotherapist
University of Sao Paulo