Post-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug

Overactive Bladder Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01627145
• Other study ID #: 201012024RC
• 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

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

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