Back to resultsPost-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug
Primary Purpose
Overactive Bladder Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Solifenacin
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder Syndrome focused on measuring overactive bladder syndrome, derusor overactivity, urodynamic studies, bladder oversensitivity
Eligibility Criteria
Inclusion Criteria:
- female patients within 18 years old to 99 years old with overactive bladder syndrome
Exclusion Criteria:
- unwilling or unable to perform testing procedure
Sites / Locations
- No 8, Chung-Shan South Road,Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
antimuscariniz drug
Arm Description
Outcomes
Primary Outcome Measures
The percentage of normalized urodynamic pattern after treatment
Secondary Outcome Measures
The percentage of recurrence rates after treatment during follow-up and further to analyze the risk factors of recurrence
Full Information
NCT ID
NCT01627145
First Posted
June 21, 2012
Last Updated
November 14, 2012
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01627145
Brief Title
Post-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug
Official Title
Post-treatment Normallized Urodynamic Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug and Its Correlations With Voiding Diary, King's Health Questionnaire, and Overactive Bladder Sympto
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
5. Study Description
Brief Summary
Post-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug and Its Conelations With Voiding Diary, King's Health Quentionaire, Overactive Bladder Sympton Scores and Patient Perception of Bladder Condition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome
Keywords
overactive bladder syndrome, derusor overactivity, urodynamic studies, bladder oversensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
antimuscariniz drug
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Solifenacin
Intervention Description
Solifenacin 5 mg qd,
Primary Outcome Measure Information:
Title
The percentage of normalized urodynamic pattern after treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The percentage of recurrence rates after treatment during follow-up and further to analyze the risk factors of recurrence
Time Frame
48 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
female patients within 18 years old to 99 years old with overactive bladder syndrome
Exclusion Criteria:
unwilling or unable to perform testing procedure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ho-Hsiung Lin, PhD
Phone
+886-2-23123456
Ext
71557
Email
hhlin@ntuh.gov.tw
Facility Information:
Facility Name
No 8, Chung-Shan South Road,
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho-Hsiung Lin, MD, PhD
Phone
+88623123456
Ext
71557
Email
hhlin@ntuh.gov.tw
First Name & Middle Initial & Last Name & Degree
Ho-Hsiung Lin, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Post-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug
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