Physical Therapy for Overactive Bladder

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01758848
First received: November 22, 2010
Last updated: December 27, 2012
Last verified: November 2012
  Purpose

Overactive bladder is a syndrome of symptoms. The core symptom is urgency with/without urge incontinence, frequency, nocturia. The prevalence of overactive bladder increased with age. The elderly is increasing with time, so the people who suffering from overactive bladder is also increasing. Research related to overactive bladder in the field of physical therapy is remained needed. The purposes of this study are to investigate the application of physical therapy to women with overactive bladder, emphasizing on the effect of voluntary muscle contraction for urgency inhibition, including the urodynamic study and clinical study.

There are three stages in this study. In the first stage, we are going to develop a specific health-related quality of life questionnaire for urinary incontinence in Taiwan version. One hundred and fifty women with urinary incontinence and fifty healthy women without lower urinary tract symptom will be recruited in the first year to investigate the reliability and validity of the questionnaire. The Short-Form 36, Chinese version, will be used as gold standard for validity. Fifty women with urgency will be recruited in the second stage to test the effect of muscle active contraction strategies to inhibit detrusor pressure and urgency. The three muscle active contraction strategies include pelvic floor muscle strong contraction, pelvic floor muscle tonic contraction, and transversus abdominis tonic contraction. The outcome variables including detrusor pressure of the urodynamic parameter and self-reported urgency score. Simultaneous image record by abdominal ultrasound during the urodynamic examination will be used to ensure the accuracy of muscle action. The predictors of success of strategy from the result of the second year will be used to stratify the patients in the third stage. Eighty women with urgency will be recruited in the final stage to examine the clinical effect of strategy for urgency inhibition.


Condition
Overactive Bladder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physical Therapy for Overactive Bladder

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • urinary diary [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 155
Study Start Date: September 2010
Study Completion Date: October 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Overactive bladder is a syndrome of symptoms. The core symptom is urgency with/without urge incontinence, frequency, nocturia. The prevalence of overactive bladder increased with age. The elderly is increasing with time, so the people who suffering from overactive bladder is also increasing. Research related to overactive bladder in the field of physical therapy is remained needed. The purposes of this study are to investigate the application of physical therapy to women with overactive bladder, emphasizing on the effect of voluntary muscle contraction for urgency inhibition, including the urodynamic study and clinical study.

There are three stages in this study. In the first stage, we are going to develop a specific health-related quality of life questionnaire for urinary incontinence in Taiwan version. One hundred and fifty women with urinary incontinence and fifty healthy women without lower urinary tract symptom will be recruited in the first year to investigate the reliability and validity of the questionnaire. The Short-Form 36, Chinese version, will be used as gold standard for validity. Fifty women with urgency will be recruited in the second stage to test the effect of muscle active contraction strategies to inhibit detrusor pressure and urgency. The three muscle active contraction strategies include pelvic floor muscle strong contraction, pelvic floor muscle tonic contraction, and transversus abdominis tonic contraction. The outcome variables including detrusor pressure of the urodynamic parameter and self-reported urgency score. Simultaneous image record by abdominal ultrasound during the urodynamic examination will be used to ensure the accuracy of muscle action. The predictors of success of strategy from the result of the second year will be used to stratify the patients in the third stage. Eighty women with urgency will be recruited in the final stage to examine the clinical effect of strategy for urgency inhibition.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

women with overactive bladder

Criteria

Inclusion Criteria:

  • women with overactive bladder

Exclusion Criteria:

-

  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: NCT01758848

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jau-Yih Tsauo, PhD School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01758848     History of Changes
Other Study ID Numbers: 200812091R
Study First Received: November 22, 2010
Last Updated: December 27, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
overactive bladder
pelvic floor muscles
deep abdominal muscles

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014