Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270738
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
2005-12-26
Brief Title:
Treatment for Female Stress Urinary Incontinence
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Treatment for Stress Urinary Incontinence-Indirect Training of Pelvic Floor Muscle Via Transversus Abdominis Muscle Contraction
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 womens observations quantification of symptoms clinicians 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 womens observations quantification of symptoms clinicians 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 110 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
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 womens observations quantification of symptoms clinicians 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 110 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None