Overactive bladder
Conditions
Interventions
1:Vesicare 5mg-10mg/day Solifenacine
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: At Screening Visit (Week -2) 1. Male or female patient aged >= 18 years; 2. Written informed consent has been obtained; 3. Patient is willing and able to complete the 3-days micturition diary correctly; 4. Symptoms of OAB (including urinary frequency, urgency with or without urge incontinence) for >=3 months; 5. At least 3 episode of urgency with or without incontinence in last 3 days. At Visit 1 (Week 0)Based on the 3-day micturition diary prior to Visit1: 1. Number of micturition per day>= 8; 2. Number of urgency episodes in 3 days >=3.
Exclusion criteria
Exclusion criteria: At Screening Visit (Week -2) 1. Significant stress incontinence or mixed stress / urge incontinence where stress is the predominant factor as determined by the investigator; 2. Patient with indwelling catheters or practicing intermittent self-catheterization; 3. Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs; 4. Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks; 5. Patients under treatment with Solifenacin and the prohibited drugs in Appendix 4; 6. Diabetic neuropathy; 7. Patients who are prohibited from taking Solifenacin as contraindications (See Appendix 5); 8. Any clinical significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial; 9. Participation in any clinical trial in 30 days except for Part 1 of RESORT; 10. Employees of the Astellas Group, third parties associated with the study, or the study site; 11. Pregnant women or women ready to pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OABS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PPBC;IPSSQOL;IPSS; | — |
Countries
China
Contacts
Public ContactJianye Wang
Outcome results
None listed