Overactive Bladder
Conditions
Interventions
OAB group:evaluate participants with OABSS, PPBC and IBSS
Sponsors
People's Hospital of Peking University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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 1 episode of urgency with or without incontinence in last 3 days; At Visit1 (Week 0) Based on the 3-day micturition diary prior to Visit1: 1. Number of micturition per day (24 h) >=8; Number of urgency episodes in 3 days >=1.
Exclusion criteria
Exclusion criteria: At Screening Visit (Week -2) 1. Female patients with pregnancy or lactation, or patient planning to be pregnant or lactate. Female patient in child-bearing age could not guarantee reliable contraceptive; 2. Significant stress incontinence or mixed stress / urge incontinence where stress is the predominant factor as determined by the investigator; 3. Patients with indwelling catheters or practicing intermittent self-catheterization; 4. 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; 5. Patient with malignant disease or radiation therapy of pelvic cavity in the past; 6. Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks; 7. Patients under treatment with the prohibited drugs in Appendix 1A; 8. Diabetic neuropathy; 9. Any clinical significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial; 10. Participation in any clinical trial in 30 days; 11. Employees of the Astellas Group, third parties associated with the study, or the study site. At Visit1 (Week 0) Patient who did not complete the 3-day micturition diary according to the instruction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reproducibility Study of OABS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cronbach's alpha-correlation of OABS; | — |
Countries
China
Contacts
Public ContactYanqun Na
Outcome results
None listed