Overactive bladder Overactive bladder
Conditions
Interventions
Switch from Beta-3 to Beta-3 Therapy for Residual Overactive Bladder Symptoms and evaluate the efficacy and safety.
Sponsors
Kato Shinobu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Has a diagnosis of OAB 2) Aged 40 years or older 3) Has remaining symptoms (OABSS total score >= 3 and urinary urgency >= 2) after mirabegron treatment for 8 weeks or more 4) IPSS-QOL score >= 4 5) Able to urinate without assistance 6) Able to record voiding diary data 7) Provided written informed consent
Exclusion criteria
Exclusion criteria: 1) Has only stress urinary incontinence 2) Post-void residual >= 100ml 3) Has a complication with similar symptoms to OAB except for prostatic hyperplasia 4) Has a malignancy 5) Has a scheduled surgical treatment for OAB or BPH during the study period 6) Has a hypersensitivity to Beta-3 agonists 7) Has previously administered vibegron 8) Considered inappropriate for participating in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of OABSS score | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Change in OABSS subscores(4 element) 2)Change in IPSS total score 3)Change in IPSS subscores(3 element and 7 element) 4)Change in IPSS-QOL score 5) Changes in the items tabulated from the voiding diary (No. of voids, urinary urgency, pressure incontinence, No. of nocturnal voiding, volume /void) and proportion of normalized subjects in these symptoms 6) Proportion of subjects with highly improved / improved in PGI assessment 7) Proportion of subjects with minimum score changes in OABSS total score 8) Correlation of OABSS subsocres and PGI | — |
Contacts
Public ContactShinobu Kato
KATO UROLOGICAL CLINIC
Outcome results
None listed