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Treatment for Female Stress Urinary Incontinence

NCT ID: NCT00270738

Last Updated: 2012-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Female Urinary Incontinence

Keywords

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urinary incontinence transversus abdominis pelvic floor muscles randomized controlled trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

TrA training group

Group Type EXPERIMENTAL

Indirect training of the PFMs via transversus abdominis

Intervention Type PROCEDURE

Individual visit: twice a month for 4 months. Exercise regimen: diaphragmatic breathing, tonic activation, muscle strengthening, functional expiratory patterns, and impact activities.

2

PFMT group

Group Type ACTIVE_COMPARATOR

pelvic floor muscle training

Intervention Type PROCEDURE

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

3

control group (PFM exercise at home)

Group Type ACTIVE_COMPARATOR

home exercise

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

pelvic floor muscle training

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

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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TrA training PFMT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jau-Yih Tsauo, PhD

Role: STUDY_DIRECTOR

Graduate School of Physical Therapy, College of Medicine, NTU

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 22446154 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21566065 (View on PubMed)

Other Identifiers

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9461700665

Identifier Type: -

Identifier Source: org_study_id