Effectiveness and Safety of Vibegron in Patients with Overactive Bladder: A Retrospective Chart Review of Patient Outcomes
Not Applicable
- Conditions
- overactive bladder
- Registration Number
- JPRN-UMIN000037233
- Lead Sponsor
- ishino Clinic, Koseikai Medical Corp.
- Brief Summary
We have evaluated the effects of vibegron on OAB. A total of 100 patients who had been administered vibegron once a day for at least 4 weeks between November 2018 and June 2019 were analyzed. The primary endpoint for effectiveness was the change in OABSS between baseline and four weeks. Four weeks after treatment, total OABSS score was significantly improved. No new safety concerns were identified.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
Nothing
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change in Overactive Bladder Symptom Score (OABSS) total score from baseline to 4 weeks
- Secondary Outcome Measures
Name Time Method 1) Change in OABSS sub-scores (4 elements) from baseline 2) Change in International Prostate Symptom Score (IPSS) total score from baseline 3) Change in IPSS sub-scores (3 and 7 elements) from baseline 4) Change in IPSS-QOL score from baseline 5) Proportion of subjects with minimum changes in OABSS total score 6) Individual scores of King's Health Questionnaire (KHQ) 7) Subgroup analyses for OABSS, IPSS, IPSS-QOL, and KHQ