Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Health-related QoF Between OAB-wet and OAB-dry Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03806855
Recruitment Status : Completed
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Overactive bladder syndrome (OAB) has a great negative impact on health-related quality of life. In literatures, few studies reported the comparisons of health related quality of life between OAB-wet and OAB-dry female patients. Thus, our aim is to compare the clinical variables and health-related quality of life between OAB-wet and OAB-dry women.

Condition or disease Intervention/treatment
Quality of Life Diagnostic Test: Bladder diary

Detailed Description:
Between July 2009 and January 2018, all women with OAB visiting a medical center for evaluation were reviewed. The classification of OAB-wet or OAB-dry is based on the record of the three-day bladder diary of each patient. The diagnosis of OAB in each patient was based on the presence of at least one episode of urgency in her three-day bladder diary and with the absence of stress urinary incontinence. The presence of at least one episode of urgency associated incontinence was defined to be OAB-wet, otherwise, OAB-dry. Besides, only female OAB patients with available King's Health Questionnaire (KHQ) data were reviewed in this study.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 1071 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Comparisons of Health-Related Quality of Life Between Overactive Bladder-wet and -Dry Women Based on Bladder Diary
Actual Study Start Date : July 1, 2009
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
OAB-wet
The diagnosis of OAB in each patient was based on the presence of at least one episode of urgency in her three-day bladder diary and with the absence of stress urinary incontinence. The presence of at least one episode of urgency associated incontinence was defined to be OAB-wet.
 Diagnostic Test: Bladder diary
3-day bladder diary
OAB-dry
The diagnosis of OAB in each patient was based on the presence of at least one episode of urgency in her three-day bladder diary and with the absence of stress urinary incontinence. The absence of urgency associated incontinence was defined to be OAB-dry.
 Diagnostic Test: Bladder diary
3-day bladder diary


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Difference in Quality of life [ Time Frame: Between July 2009 and January 2018 ]
    Use questionnaire to evaluate the difference in QoF of OAB-wet and OAB-dry women


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Between July 2009 and January 2018, all women older than 20-year-old with OAB visiting a medical center for evaluation were enrolled.
Criteria

Inclusion Criteria:

  1. More than 20-year-old
  2. Female
  3. Diagnosed with overactive bladder by bladder diary

Exclusion Criteria:

  1. Younger than 20-year-old
  2. Pregnant or planned to be pregnant
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806855


Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Ho-Hsiung Lin, PhD National Taiwan University Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03806855    
Other Study ID Numbers: 201810092RINB
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
Health Related Quality of Life
Overactive Bladder
Bladder Diary