Efficacy and Safety of Selective Serotonin Reuptake Inhibitor (SSRI) in Overactive Bladder Patients

Overactive Bladder Clinical Trial

Official title: Efficacy and Safety of SSRI in Overactive Bladder Patients; a 3-month, Prospective, Open-label, Comparative Study

Status Completed

Clinical Trial Summary

The urologic literature suggests that there is an association between a variety of psychiatric disorders and incontinence. Most notably, depression is found in a significant percentage of patients with urinary incontinence. Depression also occurs in other conditions associated with urinary urge incontinence, such as aging and dementia, and in neurologic disorders such as normal pressure hydrocephalus. Correction of some neurologic disorders eliminates both depression and urge incontinence. Although chronic medical disorders such as urge incontinence may lead to depression, an alternative hypothesis is that these two conditions share a common neurochemical pathogenesis. Lowering monoamines such as serotonin and noradrenaline in the central nervous system (CNS) leads to depression and urinary frequency and a hyperactive bladder in experimental animals. Thus, depression may not only be the result of persistent urinary incontinence, but individuals with altered CNS monoamines could manifest both depression and an overactive bladder. The latter condition may lead to urge incontinence, urinary frequency, urgency, or enuresis. Uncovering further evidence for such a linkage could serve as the basis for the development of genetic markers and novel therapeutic interventions for these two conditions.

In this study, the investigators will evaluate the efficacy and safety of SSRI on OAB patients who does not respond to the antimuscarinic agents.

Clinical Trial Description

• 3-month, prospective, open-label, comparative trial

• Primary Objectives:

• To investigate the changes of OAB symptoms in patients who did not showed therapeutic benefits after 3 months of treatment with antimuscarinic agents and who then treated with SSRI (escitalopram) for 3 months.

• Secondary Objectives

• To investigate the change of patient perception of urgency and bladder condition

• To investigate the change of patient perception of quality of life

• To investigate the change of psychologic parameters

• To investigate the patient perception of treatment benefit

• To find the predictive factors of patients who respond to the 3 month-treatment with escitalopram

• To explore the efficacy of escitalopram on the tolerability and safety ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

• NCT number: NCT00902421
• Study type: Interventional
• Source: Samsung Medical Center
• Status: Completed
• Phase: Phase 4
• Start date: January 2007
• Completion date: July 2009