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OpenTrials
Completed

NCT Number: NCT01503580

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gynecology,National Taiwan University Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all cases are female patients with lower urinary tract symptoms

Treatment and study plan

tolterodine, solifenacin

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.

Primary outcomes

  1. Changes of heart rate variability after antimuscarinics

    Time frame: 3 months

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

Secondary outcomes

  1. Changes of arterial stiffness after antimuscarinics treatment

    Time frame: 3 months

    Changes of arterial stiffness after 3-months antimuscarinics' treatment

  2. Changes of psychologic distress after antimuscarinics treatment

    Time frame: 3 months

    Changes of psychologic distress after 3-months' antimuscarinics treatment

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2013
First posted
Jan 4, 2012
Registry last updated
Oct 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.