Treatment for Female Stress Urinary Incontinence - Full Text View

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00270738

Purpose

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.

Condition	Intervention
Female Urinary Incontinence	Procedure: Indirect training of the PFMs via transversus abdominis Procedure: pelvic floor muscle training Procedure: home exercise

MedlinePlus related topics: Exercise and Physical Fitness Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
Official Title:	Treatment for Stress Urinary Incontinence—Indirect Training of Pelvic Floor Muscle Via Transversus Abdominis Muscle Contraction

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

women's observations [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

quantification of symptoms [ Time Frame: 4 months ] [ Designated as safety issue: No ]
clinical measures [ Time Frame: 4 months ] [ Designated as safety issue: No ]
quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	December 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental TrA training group	Procedure: Indirect training of the PFMs via transversus abdominis Individual visit: twice a month for 4 months. Exercise regimen: diaphragmatic breathing, tonic activation, muscle strengthening, functional expiratory patterns, and impact activities.
2: Active Comparator PFMT group	Procedure: pelvic floor muscle training Individual visit: twice a month for 4 months. Exercise: intensive pelvic floor muscle training
3: Active Comparator control group (PFM exercise at home)	Procedure: home exercise 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270738

Contacts

Contact: Jau-Yih Tsauo, PhD

886-2-33228130

jytsauo@ntu.edu.tw

Locations

Taiwan
National Taiwan University Hospital	Recruiting
Taipei, Taiwan
Contact: Jau-Yih Tsauo, PhD 886-2-33228130 jytsauo@ntu.edu.tw

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Study Director:

Jau-Yih Tsauo, PhD

Graduate School of Physical Therapy, College of Medicine, NTU

More Information

Responsible Party:	School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University ( Jau-Yih Tsauo )
Study ID Numbers:	9461700665
Study First Received:	December 26, 2005
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00270738
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

urinary incontinence
transversus abdominis
pelvic floor muscles
randomized controlled trial

Study placed in the following topic categories:

Signs and Symptoms
Urinary Incontinence, Stress
Urologic Diseases

Urination Disorders
Stress
Urinary Incontinence

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 16, 2009