In both symptom duration-based subgroups, approximately half of the patients experienced moderate bladder-related problems at baseline as measured by PPBC, and approximately one-quarter experienced severe problems, with no clinically meaningful differences between groups; other clinical characteristics were also similar between groups.
The solifenacin treatment group showed a statistically significant improvement in mean PPBC score at EOT versus placebo.
Distribution of PPBC scores at EOT is shown in Figure 4.
Compared with placebo, solifenacin was associated with statistically significant improvements in OAB-q Symptom Bother and HRQL, PPBC, and bladder diary variables after 12 weeks, both in patients who had experienced symptoms for less than five years and in those with symptoms for five years or longer.
In the sub-analysis of VOLT, patients who had experienced symptoms for between three months to one year, one year to five years, and longer than five years indicated comparable improvements in PPBC score, OAB-q score, and a visual analog scale of patient perception of symptom bother (Lucente et al.
A strength of the VIBRANT study is that it evaluated efficacy using objective, diary-based endpoints and the OAB-q and PPBC, which capture patients' perspectives on the impact of symptoms on their lives.