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

Antimuscarinic Drug Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01503580
• Other study ID #: 200712062M
• Status: Completed
• Phase: N/A
• First received: September 24, 2011
• Last updated: October 30, 2013
• Start date: August 2008
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: October 2013
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all cases are female patients with lower urinary tract symptoms

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Antimuscarinic Drug
• Urinary Bladder, Overactive

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Department of Gynecology,National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of heart rate variability after antimuscarinics	Changes of heart rate variability after 3-months' antimuscarinics treatment	3 months	Yes
Secondary	Changes of arterial stiffness after antimuscarinics treatment	Changes of arterial stiffness after 3-months antimuscarinics' treatment	3 months	Yes
Secondary	Changes of psychologic distress after antimuscarinics treatment	Changes of psychologic distress after 3-months' antimuscarinics treatment	3 months	Yes