Overactive bladder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with no treatment or more than 6 weeks pharmacotherapy for OAB. 2. Participants diagnosed as OAB by OAB symptom score (OABSS) and total score is more than 6 points (moderate or more). 3. Fully active, able to carry on all pre-disease performance without restriction (ECOG Performance Status: Grade 0). 4. Participants who understand explanation and obtain written informed consent.
Exclusion criteria
Exclusion criteria: 1. Participants has abnormality around the bladder (e.g., bladder stone, urethral stone, interstitial cystitis, endometriosis, pelvic organ prolapse). 2. Participant is diagnosed as Urinary Tract Infection (UTI). 3. Participants who have had surgery for urinary incontinence. 4. Pregnant or possibly pregnant participants. 5. Participants who can not understand the notation of Japanese. 6. Participants with depressed tendency. 7. Participants who are diagnosed as dementia. 8. Participants who are considered as inappropriate for this study by the responsible doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HRQoL total score of Overactive bladder questionnaire (OAB-q) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The other score of Overactive bladder questionnaire (OAB-q) 2. Overactive bladder symptom score (OABSS) 3. King's health questionnaire (KHQ) 4. Patient Global Impression-Improvement (PGI-I) 5. Patient Global Impression-Severity (PGI-S) 4. Euroqol-5D-5L (EQ-5D-5L) 5. Hospital Anxiety and Depression Scale (HADS) 6. Frequency volume chart 7. Participant satisfaction 8. Change of drug therapy 9. Adherence of treatment 10. Drop-out rate 11. Adverse events 12. Participant feedback | — |
Countries
Japan
Contacts
Kyoto University, Graduate School of Medicine Urology