Comparisons of 3-month Versus 6-month Solifenacin Treatment for Female OAB Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparisons of Urodynamic Effects, Urinary Nerve Growth Factor Levels and Outcomes in Female Overactive Bladder Patients After 3-month Versus 6-month Solifenacin Treatment: a Randomized Prospective Study

Conditions
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Overactive Bladder Syndrome

Intervention / Treatment
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* Drug: Solifenacin for 12 weeks
* Drug: Solifenacin for 24 weeks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who have overactive bladder syndrome Exclusion Criteria: Women who are less than 20 year-old

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solifenacin for 12 weeks group<br>Solifenacin (5 mg qd) for 12 weeks | Drug: Solifenacin for 12 weeks<br>* Solifenacin 5 mg one a day for 12 weeks<br>* Other names: Vesicare;|
| Active Comparator: Solifenacin for 24 weeks group<br>Solifenacin (5 mg qd) for 24 weeks | Drug: Solifenacin for 24 weeks<br>* Solifenacin 5 mg once a day for 24 weeks<br>* Other names: Vesicare;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of normalized urodynamic findings | The rate of normalized urodynamic finding after antimuscarinics | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 2.5 years | 
| The difference of urine nerve growth factor level | The difference of urine nerve growth factor level after antimuscarinics | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antimuscarinic treatment, urodynamic studies, nerve growth factor