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Treatment for Female Stress Urinary Incontinence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00270738
First received: December 26, 2005
Last updated: December 4, 2012
Last verified: December 2012
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment for Stress Urinary Incontinence—Indirect Training of Pelvic Floor Muscle Via Transversus Abdominis Muscle Contraction

Resource links provided by NLM:


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 ]

Enrollment: 168
Study Start Date: December 2005
Study Completion Date: March 2010
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Other Name: TrA training
Active Comparator: 2
PFMT group
Procedure: pelvic floor muscle training
Individual visit: twice a month for 4 months. Exercise: intensive pelvic floor muscle training
Other Name: PFMT
Active Comparator: 3
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.
Other Name: home exercise

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
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

No publications provided by National Taiwan University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00270738     History of Changes
Other Study ID Numbers: 9461700665
Study First Received: December 26, 2005
Last Updated: December 4, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
urinary incontinence
transversus abdominis
pelvic floor muscles
randomized controlled trial

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on November 20, 2014