Back to resultsStudies of Psychiatric Predisposing Factors, Treatment-related Cardiovascular Effects, and Prognostic Factors Associated With Antimuscarinic Drug (Tolterodine) for Female Overactive Bladder Syndrome
Primary Purpose
Antimuscarinic Drug
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
tolterodine, solifenacin
Sponsored by
About this trial
This is an interventional treatment trial for Antimuscarinic Drug
Eligibility Criteria
Inclusion Criteria:
- all cases are female patients with lower urinary tract symptoms
Sites / Locations
- Department of Gynecology,National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
antimuscarinic drug
Arm Description
Outcomes
Primary Outcome Measures
Changes of heart rate variability after antimuscarinics
Changes of heart rate variability after 3-months' antimuscarinics treatment
Secondary Outcome Measures
Changes of arterial stiffness after antimuscarinics treatment
Changes of arterial stiffness after 3-months antimuscarinics' treatment
Changes of psychologic distress after antimuscarinics treatment
Changes of psychologic distress after 3-months' antimuscarinics treatment
Full Information
NCT ID
NCT01503580
First Posted
September 24, 2011
Last Updated
October 30, 2013
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01503580
Brief Title
Studies of Psychiatric Predisposing Factors, Treatment-related Cardiovascular Effects, and Prognostic Factors Associated With Antimuscarinic Drug (Tolterodine) for Female Overactive Bladder Syndrome
Official Title
Studies of Psychiatric Predisposing Factors, Treatment-related Cardiovascular Effects, and Prognostic Factors Associated With Antimuscarinic Drug (Tolterodine) for Female Overactive Bladder Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Overactive bladder syndrome (OAB) affects around 17 % of female population. However, the etiology of OAB was complicated and unclear in many aspects. In particular, the research about psychiatric aspect of etiology in OAB was paucity. Besides, research about prognostic factors and impact of cardiovascular system of OAB treatment was also paucity. Therefore the aims of the investigators study were (1) to analyze the etiology of OAB in psychiatric aspects; (2) to analyze the prognostic factors associated with tolterodine treatment; (3) to analyze the differences of cardiac conduction and heart rate variability before and after tolterodine treatment; (4) to analyze the differences of arterial stiffness between non-OAB and OAB female patients, and before and after tolterodine treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antimuscarinic Drug
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
155 (Actual)
8. Arms, Groups, and Interventions
Arm Title
antimuscarinic drug
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
tolterodine, solifenacin
Intervention Description
The enrolled women before March 2009 were treated with tolterodine 4 mg slow-release, and after March 2009 were treated with solifenacin 5 mg once a day for 12 weeks.
Primary Outcome Measure Information:
Title
Changes of heart rate variability after antimuscarinics
Description
Changes of heart rate variability after 3-months' antimuscarinics treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Changes of arterial stiffness after antimuscarinics treatment
Description
Changes of arterial stiffness after 3-months antimuscarinics' treatment
Time Frame
3 months
Title
Changes of psychologic distress after antimuscarinics treatment
Description
Changes of psychologic distress after 3-months' antimuscarinics treatment
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all cases are female patients with lower urinary tract symptoms
Facility Information:
Facility Name
Department of Gynecology,National Taiwan University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Studies of Psychiatric Predisposing Factors, Treatment-related Cardiovascular Effects, and Prognostic Factors Associated With Antimuscarinic Drug (Tolterodine) for Female Overactive Bladder Syndrome
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