Treatment for Female Stress Urinary Incontinence

Female Urinary Incontinence Clinical Trial

Official title:

Treatment for Stress Urinary Incontinence—Indirect Training of Pelvic Floor Muscle Via Transversus Abdominis Muscle Contraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270738
• Other study ID #: 9461700665
• Status: Completed
• Phase: N/A
• First received: December 26, 2005
• Last updated: December 4, 2012
• Start date: December 2005
• Est. completion date: March 2010

Study information

• Verified date: December 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: March 2010
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Female Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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.
• pelvic floor muscle training
Individual visit: twice a month for 4 months. Exercise: intensive pelvic floor muscle training
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	women's observations		4 months	No
Secondary	quantification of symptoms		4 months	No
Secondary	clinical measures		4 months	No
Secondary	quality of life		4 months	No