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

Not Applicable

Completed

• Conditions: Antimuscarinic Drug
• Interventions: Drug: tolterodine, solifenacin

• Registration Number: NCT01503580
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2010-07
• Study First Submitted: 2011-09-24
• Study First Submitted QC: 2012-01-03
• Study First Posted: 2012-01-04
• Status Verified: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 155

Inclusion Criteria

• all cases are female patients with lower urinary tract symptoms

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
antimuscarinic drug	tolterodine, solifenacin	-

Primary Outcome Measures

Name	Time	Method
Changes of heart rate variability after antimuscarinics	3 months	Changes of heart rate variability after 3-months' antimuscarinics treatment

Secondary Outcome Measures

Name	Time	Method
Changes of arterial stiffness after antimuscarinics treatment	3 months	Changes of arterial stiffness after 3-months antimuscarinics' treatment
Changes of psychologic distress after antimuscarinics treatment	3 months	Changes of psychologic distress after 3-months' antimuscarinics treatment

Trial Locations

Locations (1)

Department of Gynecology,National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan