Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Primary Objective:
Secondary Objective:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tolterodine 1 | Experimental |
| |
| Toterodine 3 | Experimental |
| |
| Tolterodine 6 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolterodine | Drug | Extended release tolterodine tartrate 4 mg, once daily, for 1 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Risk factors and relapse rate of the OAB symptoms after drug discontinuation | from baseline (treatment completion) to 1, 3 month after drug discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Micturition diary efficacy parameters | from baseline (treatment completion) to 1, 3 month after drug discontinuation | |
| Quality of life parameters: change in total score and subscale scores of OAB-questionnaire | from baseline (treatment completion) to 1, 3 month after drug discontinuation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kyu-Sung Lee, Ph.D | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Irwon-dong | Seoul | 135-710 | South Korea | ||
| Holy Family Hospital, The Catholic University of Korea |
Not provided
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068737 | Tolterodine Tartrate |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tolterodine | Drug | Extended release tolterodine tartrate 4 mg, once daily, for 3 months |
|
|
| Tolterodine 6 | Drug | Extended release tolterodine tartrate 4 mg, once daily, for 6 months |
|
|
| Patient perceptions: change in patient perception of urgency, change in patient perception of bladder condition and percentage of patients who wants retreatment | from baseline (treatment completion) to 1, 3 month after drug discontinuation |
| Gyeonggi-do |
| South Korea |
| Asan Medical Center, Ulsan College of Medicine | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |