- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01627145
Post-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug
November 14, 2012 updated by: National Taiwan University Hospital
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
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ho-Hsiung Lin, PhD
- Phone Number: 71557 +886-2-23123456
- Email: hhlin@ntuh.gov.tw
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- No 8, Chung-Shan South Road,
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: antimuscariniz drug
|
Solifenacin 5 mg qd,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The percentage of normalized urodynamic pattern after treatment
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The percentage of recurrence rates after treatment during follow-up and further to analyze the risk factors of recurrence
Time Frame: 48 months
|
48 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Anticipated)
January 1, 2015
Study Completion (Anticipated)
July 1, 2015
Study Registration Dates
First Submitted
June 21, 2012
First Submitted That Met QC Criteria
June 22, 2012
First Posted (Estimate)
June 25, 2012
Study Record Updates
Last Update Posted (Estimate)
November 15, 2012
Last Update Submitted That Met QC Criteria
November 14, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder, Overactive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Solifenacin Succinate
Other Study ID Numbers
- 201012024RC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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