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

NCT ID: NCT01503580

Last Updated: 2013-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2013-10-31

Brief Summary

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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

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Conditions

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Antimuscarinic Drug

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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antimuscarinic drug

Group Type EXPERIMENTAL

tolterodine, solifenacin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* all cases are female patients with lower urinary tract symptoms
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Gynecology,National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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200712062M

Identifier Type: -

Identifier Source: org_study_id