Pooled analysis Cohort A: 3 randomized, placebo-controlled, double-blind studies and 1 open-label, single arm trial Cohort B: one randomized, placebo-controlled, double-blind study
PGI-I much or very much better: Cohort A: 71.5% Cohort B: 57.4% Decrease in SUI episodes at end point: Cohort A: N/A Cohort B: ≈70% Discontinued by 12 months: Cohort A: 57.5% Cohort B: 79.5%
Discontinued by 4 wks: 69% Discontinued by 12 mos: 91% At 12 mos, 10 women were on no treatment and had not undergone surgery; of these, 6 were considered cured
Abbreviations: N/A, not available; PGI-I, Patient Global Impression-Improvement rating scale.