Treatment for Female Stress Urinary Incontinence
Condition: Female Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      Urinary incontinence (UI) is the complaint of any involuntary leakage of urine. Stress
      urinary incontinence (SUI) is the complaint of involuntary leakage on effort or exertion, or
      on sneezing or coughing. The prevalence of female UI is greater than that of male, and the
      commonest type is SUI. UI has significant impact on the quality of life including physical,
      mental and social issues. SUI may also lead to withdraw from regular physical exercise and
      fitness activities that important in the prevention of osteoporosis, coronary heart disease,
      and so on. The cause of SUI is related to the impairment of pelvic floor muscles (PFM). So
      far, the effects of intensive pelvic floor muscle training for female SUI were proved in many
      randomized controlled trials. However, training of accurate contraction of PFM depends on
      vaginal palpation. The willingness to seek for medical help may be reduced due to being
      embarrassed with vaginal palpation. Sapsford proposed a concept to treat SUI via transversus
      abdominis (TrA) that does not need to palpate the vagina. Maybe the new intervention can
      promote the willingness to seek medical help. However, to date there is no randomized
      controlled trial comparing the effect of indirect training of the PFM via TrA with either
      untreated control or other intervention. Therefore, there are two purposes in this study, to
      compare the effect of indirect training of PFM via TrA with control group and to compare the
      effect of indirect training of PFM via TrA with PFMT for female SUI.
    

Detailed description: 
      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.
    

Intervention name(s): Indirect training of the PFMs via transversus abdominis; pelvic floor muscle training; home exercise
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Individual visit: twice a month for 4 months. Exercise regimen: diaphragmatic breathing, tonic activation, muscle strengthening, functional expiratory patterns, and impact activities.; Individual visit: twice a month for 4 months. Exercise: intensive pelvic floor muscle training; 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.
Other intervention name(s): TrA training; PFMT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: urinary incontinence; transversus abdominis; pelvic floor muscles; randomized controlled trial