Table 1.
Baseline Characteristics by Study Drug Treatment in Women Participating in Phase 1 URO-902 Trials
| Characteristic | ION-02 Study | ION-03 Study | ||||
|---|---|---|---|---|---|---|
| URO-902 by Intravesical Instillation 5 mg (n=10) | URO-902 by Intravesical Instillation 10 mg (n=6) | Placebo (n=5) | URO-902 by Detrusor Injection 16 mg (n=6) | URO-902 by Detrusor Injection 24 mg (n=3) | Placebo (n=4) | |
| Age (years), mean (SD) | 62.6 (15.2) | 65.8 (14.4) | 69.8 (9.8) | 55.8 (4.6) | 65.1 (9.2) | 57.0 (6.8) |
| Race, n (%) | ||||||
| White | 9 (90.0) | 6 (100.0) | 4 (80.0) | 2 (33.3) | 2 (66.7) | 4 (100.0) |
| Black/African American | 1 (10.0) | 0 | 0 | 4 (66.7) | 1 (33.3) | 0 |
| Ethnicity, n (%) | ||||||
| Latino/Hispanic | 0 | 0 | 1 (20.0) | 0 | 1 (33.3) | 0 |
| Micturitions/day, mean (SD) | 11.5 (3.4) | 11.2 (4.7) | 10.1 (3.2) | 11.3 (2.7) | 17.2 (7.1) | 10.2 (4.8) |
| Urgency episodes/day, mean (SD) | 11.5 (3.2) | 11.2 (4.7) | 10.1 (3.2) | 10.2 (3.6) | 17.2 (7.1) | 9.8 (5.2) |
| Urgency incontinence episodes/day, mean (SD) | 2.7 (2.3) | 2.2 (2.2) | 5.3 (3.6) | 1.9 (0.8) | 3.8 (3.3) | 1.8 (1.5) |
Note: Adapted from Rovner E, Chai TC, Jacobs S, et al. Evaluating the safety and potential activity of URO-902 (hMaxi-K) gene transfer by intravesical instillation or direct injection into the bladder wall in female participants with idiopathic (non-neurogenic) overactive bladder syndrome and detrusor overactivity from two double-blind, imbalanced, placebo-controlled randomized phase 1 trials. Neurourol Urodyn. 2020;39(2):744–753. doi:10.1002/nau.24272. © 2020 The Authors. Neurourology and Urodynamics published by Wiley Periodicals, Inc.22
Abbreviation: SD, standard deviation.