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

This study is currently recruiting participants.
Verified November 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01627145
First received: June 21, 2012
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: National Taiwan University Hospital, Professor, Department of Obstetrics & Gynecology
ClinicalTrials.gov Identifier: NCT01627145     History of Changes
Other Study ID Numbers: 201012024RC
Study First Received: June 21, 2012
Last Updated: November 14, 2012
Health Authority: Taiwan: Department of Health

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
Urological Manifestations
Signs and Symptoms
Muscarinic Antagonists
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
 Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013