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.

Study Overview

• Status: Completed
• Conditions: Antimuscarinic Drug
• Intervention / Treatment: Drug: tolterodine, solifenacin

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Department of Gynecology,National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• all cases are female patients with lower urinary tract symptoms

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: antimuscarinic drug	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of heart rate variability after antimuscarinics	Changes of heart rate variability after 3-months' antimuscarinics treatment	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of arterial stiffness after antimuscarinics treatment	Changes of arterial stiffness after 3-months antimuscarinics' treatment	3 months
Changes of psychologic distress after antimuscarinics treatment	Changes of psychologic distress after 3-months' antimuscarinics treatment	3 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: September 24, 2011
• First Submitted That Met QC Criteria: January 3, 2012
• First Posted (Estimate): January 4, 2012

Study Record Updates

• Last Update Posted (Estimate): October 31, 2013
• Last Update Submitted That Met QC Criteria: October 30, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Solifenacin Succinate; Tolterodine Tartrate
• Other Study ID Numbers: 200712062M