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To investigate whether prolonged period of treatment (6 months) can have a better therapeutic outcome than conventional period (3 months) of antimuscarinics.
Overactive bladder syndrome (OAB), with or without urge incontinence, is characterized by urinary urgency, frequency and nocturia. Thus, patients with OAB could be considered to have a reduced quality of life. Patients with overactive bladder syndrome have a higher risk of falling and fracture due to nocturia. OAB affects around 17 % of female population. At present, muscarinic receptor antagonists are the first-line pharmacotherapeutic agents for OAB. However, discontinuation of the treatment often results in symptom relapse. Until now, optimal duration of the treatment and durability of the efficacy have not been determined. We plan to use urodynamic studies outcome to evaluate therapeutic effect, with the change of urinary nerve growth factor level. This study is a randomized prospective study, comparing female OAB patient after 3 months and 6 months of antimuscarinic treatment.
The purpose of this study is to investigate the difference of urodynamic effects, therapeutic effect and urinary urinary nerve growth factor level between OAB females after 3 months and 6 months antimuscarinic treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solifenacin for 12 weeks group | Experimental | Solifenacin (5 mg qd) for 12 weeks |
|
| Solifenacin for 24 weeks group | Active Comparator | Solifenacin (5 mg qd) for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solifenacin for 12 weeks | Drug | Solifenacin 5 mg one a day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of normalized urodynamic findings | The rate of normalized urodynamic finding after antimuscarinics | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The cure rate of overactive bladder | The cure rate of overactive bladder after antimuscarinics | 24 weeks |
| The recurrence rate of overactive bladder | The recurrence rate of overactive bladder after antimuscarinics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ho-Hsiung Lin, MD, PhD | Contact | +886-2-23123456 | 71557 | hhlin@ntuh.gov.tw |
| Name | Affiliation | Role |
|---|---|---|
| Ho-Hsiung Lin, MD, PhD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics & Gynecology, National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
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| ID | Term |
|---|---|
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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| Solifenacin for 24 weeks | Drug | Solifenacin 5 mg once a day for 24 weeks |
|
|
| 2.5 years |
| The difference of urine nerve growth factor level | The difference of urine nerve growth factor level after antimuscarinics | 24 weeks |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |