Female Urinary Incontinence Clinical Trial
Official title:
Treatment for Stress Urinary Incontinence—Indirect Training of Pelvic Floor Muscle Via Transversus Abdominis Muscle Contraction
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06291441 -
Women Urinary Incontinence Prevalence Study (WUIPS)
|