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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01627145
Other study ID # 201012024RC
Secondary ID
Status Recruiting
Phase N/A
First received June 21, 2012
Last updated November 14, 2012
Start date August 2012
Est. completion date July 2015

Study information

Verified date November 2012
Source National Taiwan University Hospital
Contact Ho-Hsiung Lin, PhD
Phone +886-2-23123456
Email hhlin@ntuh.gov.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date July 2015
Est. primary completion date January 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Solifenacin
Solifenacin 5 mg qd,

Locations

Country Name City State
Taiwan No 8, Chung-Shan South Road, Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The percentage of normalized urodynamic pattern after treatment 12 weeks No
Secondary The percentage of recurrence rates after treatment during follow-up and further to analyze the risk factors of recurrence 48 months No
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