NCT00730535

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: KYU-SUNG LEE · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	Tolterodine	Extended release tolterodine tartrate 4 mg, once daily, for 1 months
DRUG	Tolterodine	Extended release tolterodine tartrate 4 mg, once daily, for 3 months
DRUG	Tolterodine 6	Extended release tolterodine tartrate 4 mg, once daily, for 6 months

Timeline

• Start date: 2006-08-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-08-08
• Last updated: 2019-12-02

Locations

4 sites across 1 country: South Korea