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

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ClinicalTrials.gov Identifier: NCT01627145
Recruitment Status : Unknown
Verified November 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : June 25, 2012
Last Update Posted : November 15, 2012
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Syndrome Drug: Solifenacin Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2012
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: antimuscariniz drug Drug: Solifenacin
Solifenacin 5 mg qd,



Primary Outcome Measures :
  1. The percentage of normalized urodynamic pattern after treatment [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. The percentage of recurrence rates after treatment during follow-up and further to analyze the risk factors of recurrence [ Time Frame: 48 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01627145


Contacts
Contact: Ho-Hsiung Lin, PhD +886-2-23123456 ext 71557 hhlin@ntuh.gov.tw

Locations
Taiwan
No 8, Chung-Shan South Road, Recruiting
Taipei, Taiwan, 100
Contact: Ho-Hsiung Lin, MD, PhD    +88623123456 ext 71557    hhlin@ntuh.gov.tw   
Principal Investigator: Ho-Hsiung Lin, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital, Professor, Department of Obstetrics & Gynecology
ClinicalTrials.gov Identifier: NCT01627145     History of Changes
Other Study ID Numbers: 201012024RC
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: November 15, 2012
Last Verified: November 2012

Keywords provided by National Taiwan University Hospital:
overactive bladder syndrome
derusor overactivity
urodynamic studies
bladder oversensitivity

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents