Treatment for Female Stress Urinary Incontinence
关键词
抽象
描述
In the first period (part I), 100 women with SUI will be recruited in this study and randomized to intervention or control group after stratified by the moving direction of PFM during contraction of TrA. All subjects will be evaluated pre- and post- 4-month intervention. The measurements included basic data and comprehensive urogynaecological history, women's observations, quantification of symptoms, clinician's measures and quality of life.
Women in the control group will receive customary information of PFM exercise and they can decide by themselves to receive an intensive pelvic floor muscle training after control period or not. The intervention group will follow a specially designed exercise course including diaphragmatic breathing, tonic activation, muscle strengthening, functional expiratory patterns and impact activities. They will be individually trained by a physical therapist for 30-60 minutes eight times during intervention period.
In the second period (part II), another 100 women with SUI will be recruited in this study and randomized to intervention or control group. All subjects will be evaluated pre- and post- 4-month intervention. The measurements included basic data and comprehensive urogynaecological history, women's observations, quantification of symptoms, clinician's measures and quality of life.
Women in the control group will receive customary information of PFM exercise and they can decide by themselves to receive intensive pelvic floor muscle training after control period or not. The intervention group will received intensive pelvic floor muscle training. They will be individually trained by a physical therapist for 30-60 minutes eight times during intervention period.
Descriptive and inferential statistics will be completed using SPSS for windows, version 11.0. Descriptive statistics will be computed for subject demographics. Normality will be evaluated by using the Shapiro-Wilk test for all variables. The confounding factors between two groups will be tested by the independent t-test or Chi-square test. A two-way mixed analysis of variance (ANOVA) and Friedman test will be used to assess possible difference between pre- and post- intervention and two groups. The Chi-square will be used to assess the discount dependent variables.
日期
| 最后验证: | 11/30/2012 |
| 首次提交: | 12/25/2005 |
| 提交的预估入学人数: | 12/25/2005 |
| 首次发布: | 12/27/2005 |
| 上次提交的更新: | 12/03/2012 |
| 最近更新发布: | 12/05/2012 |
| 实际学习开始日期: | 11/30/2005 |
| 预计主要完成日期: | 11/30/2006 |
| 预计完成日期: | 02/28/2010 |
状况或疾病
干预/治疗
Procedure: 1
Procedure: 2
Procedure: 3
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: 1 TrA training group | Procedure: 1 Individual visit: twice a month for 4 months. Exercise regimen: diaphragmatic breathing, tonic activation, muscle strengthening, functional expiratory patterns, and impact activities. |
| Active Comparator: 2 PFMT group | Procedure: 2 Individual visit: twice a month for 4 months. Exercise: intensive pelvic floor muscle training |
| Active Comparator: 3 control group (PFM exercise at home) | Procedure: 3 PFM exercise at home: at least six high-intensity (near-maximum) contractions 3 times per day at home, with an aim at holding each muscle contraction for 10 seconds, with at least a 10-second rest between contractions. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - female with stress urinary incontinence episodes during last month Exclusion Criteria: - Systemic neuromuscular disease - Previous medication、surgery、PFMT for urinary incontinence - Previous surgery of bladder or low back - RAH - During pregnancy or after childbirth<3 m/o - Severe prolapse of bladder or uterus |
结果
主要结果指标
1. women's observations [4 months]
次要成果指标
1. quantification of symptoms [4 months]
2. clinical measures [4 months]
3. quality of life [4 months]
