Treatment for Female Stress Urinary Incontinence
Primary Purpose
Female Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Indirect training of the PFMs via transversus abdominis
pelvic floor muscle training
home exercise
Sponsored by
About this trial
This is an interventional treatment trial for Female Urinary Incontinence focused on measuring urinary incontinence, transversus abdominis, pelvic floor muscles, randomized controlled trial
Eligibility Criteria
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
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
TrA training group
PFMT group
control group (PFM exercise at home)
Outcomes
Primary Outcome Measures
women's observations
Secondary Outcome Measures
quantification of symptoms
clinical measures
quality of life
Full Information
NCT ID
NCT00270738
First Posted
December 26, 2005
Last Updated
December 4, 2012
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00270738
Brief Title
Treatment for Female Stress Urinary Incontinence
Official Title
Treatment for Stress Urinary Incontinence-Indirect Training of Pelvic Floor Muscle Via Transversus Abdominis Muscle Contraction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Urinary Incontinence
Keywords
urinary incontinence, transversus abdominis, pelvic floor muscles, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
TrA training group
Arm Title
2
Arm Type
Active Comparator
Arm Description
PFMT group
Arm Title
3
Arm Type
Active Comparator
Arm Description
control group (PFM exercise at home)
Intervention Type
Procedure
Intervention Name(s)
Indirect training of the PFMs via transversus abdominis
Other Intervention Name(s)
TrA training
Intervention Description
Individual visit: twice a month for 4 months. Exercise regimen: diaphragmatic breathing, tonic activation, muscle strengthening, functional expiratory patterns, and impact activities.
Intervention Type
Procedure
Intervention Name(s)
pelvic floor muscle training
Other Intervention Name(s)
PFMT
Intervention Description
Individual visit: twice a month for 4 months. Exercise: intensive pelvic floor muscle training
Intervention Type
Procedure
Intervention Name(s)
home exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
women's observations
Time Frame
4 months
Secondary Outcome Measure Information:
Title
quantification of symptoms
Time Frame
4 months
Title
clinical measures
Time Frame
4 months
Title
quality of life
Time Frame
4 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jau-Yih Tsauo, PhD
Organizational Affiliation
Graduate School of Physical Therapy, College of Medicine, NTU
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
22446154
Citation
Hung HC, Chih SY, Lin HH, Tsauo JY. Exercise adherence to pelvic floor muscle strengthening is not a significant predictor of symptom reduction for women with urinary incontinence. Arch Phys Med Rehabil. 2012 Oct;93(10):1795-800. doi: 10.1016/j.apmr.2012.03.010. Epub 2012 Mar 23.
Results Reference
derived
PubMed Identifier
21566065
Citation
Hung HC, Hsiao SM, Chih SY, Lin HH, Tsauo JY. Effect of pelvic-floor muscle strengthening on bladder neck mobility: a clinical trial. Phys Ther. 2011 Jul;91(7):1030-8. doi: 10.2522/ptj.20100186. Epub 2011 May 12.
Results Reference
derived
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Treatment for Female Stress Urinary Incontinence
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