Overactive Bladder Syndrome
Conditions
Keywords
antimuscarinic treatment, urodynamic studies, nerve growth factor
Brief summary
To investigate whether prolonged period of treatment (6 months) can have a better therapeutic outcome than conventional period (3 months) of antimuscarinics.
Detailed description
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.
Interventions
DRUGSolifenacin for 24 weeks
Solifenacin 5 mg once a day for 24 weeks
DRUGSolifenacin for 12 weeks
Solifenacin 5 mg one a day for 12 weeks
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women who have overactive bladder syndrome
Exclusion criteria
* Women who are less than 20 year-old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of normalized urodynamic findings | 6 months | The rate of normalized urodynamic finding after antimuscarinics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The cure rate of overactive bladder | 24 weeks | The cure rate of overactive bladder after antimuscarinics |
| The recurrence rate of overactive bladder | 2.5 years | The recurrence rate of overactive bladder after antimuscarinics |
| The difference of urine nerve growth factor level | 24 weeks | The difference of urine nerve growth factor level after antimuscarinics |
Countries
Taiwan
Contacts
Primary ContactHo-Hsiung Lin, MD, PhD
Outcome results
None listed