Studies of Psychiatric Predisposing Factors, Treatment-related Cardiovascular Effects, and Prognostic Factors Associated With Antimuscarinic Drug (Tolterodine) for Female Overactive Bladder Syndrome

Overview

Overactive bladder syndrome (OAB) affects around 17 % of female population. However, the etiology of OAB was complicated and unclear in many aspects. In particular, the research about psychiatric aspect of etiology in OAB was paucity. Besides, research about prognostic factors and impact of cardiovascular system of OAB treatment was also paucity. Therefore the aims of the investigators study were (1) to analyze the etiology of OAB in psychiatric aspects; (2) to analyze the prognostic factors associated with tolterodine treatment; (3) to analyze the differences of cardiac conduction and heart rate variability before and after tolterodine treatment; (4) to analyze the differences of arterial stiffness between non-OAB and OAB female patients, and before and after tolterodine treatment.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2010

Interventions

  • Drug: tolterodine, solifenacin
    • The enrolled women before March 2009 were treated with tolterodine 4 mg slow-release, and after March 2009 were treated with solifenacin 5 mg once a day for 12 weeks.

Arms, Groups and Cohorts

  • Experimental: antimuscarinic drug

Clinical Trial Outcome Measures

Primary Measures

  • Changes of heart rate variability after antimuscarinics
    • Time Frame: 3 months
    • Changes of heart rate variability after 3-months’ antimuscarinics treatment

Secondary Measures

  • Changes of arterial stiffness after antimuscarinics treatment
    • Time Frame: 3 months
    • Changes of arterial stiffness after 3-months antimuscarinics’ treatment
  • Changes of psychologic distress after antimuscarinics treatment
    • Time Frame: 3 months
    • Changes of psychologic distress after 3-months’ antimuscarinics treatment

Participating in This Clinical Trial

Inclusion Criteria

  • all cases are female patients with lower urinary tract symptoms

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Taiwan University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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