跳至主要内容
临床试验/NCT01948713
NCT01948713已完成不适用

Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence: Randomized Blind Clinical Trial

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2013年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
2
主要终点
Change in frequence of urinary incontinence

研究概览

简要总结

INTRODUCTION: Stress urinary incontinence is a common condition in women and can be defined as the involuntary loss of urine on exertion, exercise, sneezing or coughing. This pathology causes physical discomfort and impacts the quality of life in a negative manner. Physiotherapeutic exercises is a treatment with low cost and high patient attendance. It can be applied with focus on strengthening the pelvic floor muscles or on muscular synergism. OBJECTIVE: To compare the effectiveness of Kegel exercises performed alone or performed in association with the strengthening of the muscles of the hip in the treatment of stress urinary incontinence. METHODOLOGY: The study is a randomized, blinded clinical trial. It aims at assessing objectively the strength of the pelvic floor, the improvement in the number of episodes of loss and impact on quality of life. The study will accept up to 40 women, who will be divided into two groups of physical therapy: group 1 (that will strengthen the pelvic floor muscles with Kegel exercises) and group 2 (that will perform strengthening the pelvic floor muscles with Kegel exercises associated with the strengthening of muscles of the hip). The two groups will be evaluated at the beginning and at the end of treatment.

详细描述

the strength of the pelvic floor muscles will be evaluated with the aid of a perineometer

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
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with 30 to 70 years of age;
  • Clinical diagnosis of stress urinary incontinence;
  • Urodynamic study.

排除标准

  • Stress urinary incontinence with sphincter deficiency;
  • Urinary urgence;
  • Mixed urinary incontinence;
  • Pregnant women;
  • Neurological or muscular disease that interfere with continence;
  • Urinary infection;
  • Genital prolapse;
  • Gynecological surgery for urinary incontinence in the last year;
  • Hormone replacement therapy;
  • Strength 0 in functional evaluation of the pelvic floor muscles.

结局指标

主要结局

Change in frequence of urinary incontinence

时间窗: At the first session of physical therapy and after 10 weeks of physical therapy treatment a voiding diary will be applied, and every session a follow up diary will be used. The physiotherapy treatment will be held twice a week for 10 weeks.

number of episodes of urinary leakage per week

次要结局

  • Change in quality of life(At the first session of physical therapy and after 10 weeks of physical therapy treatment . The physiotherapy treatment will be held twice a week for 10 weeks.)
  • Change in strength of pelvic floor muscles(At the first session of physical therapy and after 10 weeks of physical therapy treatment . The physiotherapy treatment will be held twice a week for 10 weeks.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验