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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01627145
First Posted: June 25, 2012
Last Update Posted: November 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose
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 Intervention
Overactive Bladder Syndrome Drug: Solifenacin

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

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

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

Estimated Enrollment: 300
Study Start Date: August 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: antimuscariniz drug Drug: Solifenacin
Solifenacin 5 mg qd,

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: National Taiwan University Hospital, Professor, Department of Obstetrics & Gynecology
ClinicalTrials.gov Identifier: NCT01627145     History of Changes
Other Study ID Numbers: 201012024RC
First Submitted: June 21, 2012
First Posted: June 25, 2012
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


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