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Exploring Predictors of Symptoms Relapse After Discontinuation of Treatment in Overactive Bladder (OAB) Patients

Overactive Bladder Clinical Trial

Official title:
Exploring Predictors of Symptoms Relapse After Discontinuation of Successful Treatment With a Tolterodine Prolonged Release Capsules (4 mg, Once Daily) in Overactive Bladder Patients: A Prospective Randomized Multicenter Trial

Clinical Trial Summary

This is a Phase IV, prospective, randomized, multi-center study to find risk factors of OAB symptoms relapse in patients who showed therapeutic benefits after 1, 3, or 6 months of treatment with Tolterodine SR and who then discontinued these antimuscarinics for 3 month.

Patients who have OAB symptoms for 6 or more than 6 months and who show successful treatment response to 1 month of treatment with Tolterodine SR 4mg will be enrolled and randomized to 1, 3 or 6 months of treatment group. After completion of the treatment, subjects will be evaluated for changes in OAB symptoms and retreatment rate will be assessed.

Clinical Trial Description

Primary Objective:

- To investigate the risk factors of OAB symptom relapse and retreatment in patients who showed therapeutic benefits after 1, 3 or 6 months of treatment with Tolterodine SR and who then discontinued these antimuscarinics for 3 month.

Secondary Objective:

- To investigate the change of the patient perception and quality of life after antimuscarinic discontinuation

- To find the rate of patients who have OAB symptom relapse.

- To find the risk factors of patients who want retreatment.

- To find the rate of patients who want retreatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00730535
Study type Interventional
Source Samsung Medical Center
Contact
Status Completed
Phase Phase 4
Start date August 2006
Completion date July 2009
View Details
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