NCT01758848

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
Last Updated

January 1, 2013

Status Verified

November 1, 2012

Enrollment Period

9 months

First QC Date

November 22, 2010

Last Update Submit

December 27, 2012

Conditions

Keywords

overactive bladderpelvic floor musclesdeep abdominal muscles

Outcome Measures

Primary Outcomes (1)

  • urinary diary

    7 days

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women with overactive bladder

You may qualify if:

  • women with overactive bladder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jau-Yih Tsauo, PhD

    School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2010

First Posted

January 1, 2013

Study Start

September 1, 2010

Primary Completion

June 1, 2011

Study Completion

October 1, 2012

Last Updated

January 1, 2013

Record last verified: 2012-11

Locations