Introduction
Materials and methods
Subjects and study design
Statistical analyses
Results
Baseline characteristics
Analyses by sex | Analyses by PSA categories | |||||||
---|---|---|---|---|---|---|---|---|
Women | Men | Men with lower PSA levels | Men with higher PSA levels | |||||
Placebo | OnabotA 100 U | Placebo | OnabotA 100 U | Placebo | OnabotA 100 U | Placebo | OnabotA 100 U | |
Baseline demographics | (n = 94) | (n = 92) | (n = 30) | (n = 32) | (n = 19) | (n = 21) | (n = 11) | (n = 11) |
Age (years) | 66.0 ± 12.09 | 64.1 ± 12.63 | 66.9 ± 12.67 | 70.2 ± 10.80 | 67.7 ± 13.85 | 68.4 ± 12.06 | 65.6 ± 10.84 | 73.5 ± 7.20 |
Weight (kg) | 56.11 ± 10.90 | 56.33 ± 10.61 | 68.87 ± 12.11 | 63.84 ± 9.36 | 70.30 ± 13.22 | 64.57 ± 9.89 | 66.39 ± 10.01 | 62.45 ± 8.52 |
Height (cm) | 153.76 ± 5.83 | 153.29 ± 6.38 | 164.93 ± 5.48 | 163.79 ± 7.80 | 165.69 ± 6.16 | 163.87 ± 8.34 | 163.62 ± 3.96 | 163.65 ± 7.02 |
OAB history (years) | 4.51 ± 4.26 | 4.91 ± 4.10 | 3.18 ± 3.10 | 6.09 ± 6.54 | 3.68 ± 3.61 | 6.67 ± 7.61 | 2.30 ± 1.76 | 4.99 ± 3.83 |
PVR urine volume < 100 mL, n (%) | 94 (100) | 92 (100) | 30 (100) | 32 (100) | 19 (100) | 21 (100) | 11 (100) | 11 (100) |
Number of daily episodes | ||||||||
UI | 6.09 ± 3.60 | 7.18 ± 4.11 | 6.19 ± 4.66 | 6.50 ± 6.39 | 6.89 ± 5.05 | 6.38 ± 5.34 | 5.00 ± 3.86 | 6.73 ± 8.34 |
UUI | 5.77 ± 3.48 | 6.65 ± 4.00 | 5.50 ± 3.75 | 6.29 ± 6.44 | 5.89 ± 3.72 | 6.11 ± 5.39 | 4.85 ± 3.94 | 6.64 ± 8.39 |
Micturition | 12.16 ± 2.95 | 11.93 ± 3.09 | 14.46 ± 3.89 | 13.00 ± 5.08 | 14.07 ± 4.01 | 12.65 ± 4.32 | 15.18 ± 3.72 | 13.67 ± 6.48 |
Urgency | 8.70 ± 3.52 | 8.82 ± 4.17 | 12.17 ± 4.98 | 10.23 ± 6.18 | 12.39 ± 4.33 | 9.83 ± 5.00 | 11.82 ± 6.17 | 11.00 ± 8.21 |
Nocturia | 1.72 ± 1.38 | 1.51 ± 1.48 | 2.30 ± 1.42 | 2.27 ± 1.33 | 2.56 ± 1.51 | 2.38 ± 1.39 | 1.88 ± 1.24 | 2.12 ± 1.27 |
Volume voided per micturition (mL) | 135.96 ± 49.74 | 134.25 ± 49.63 | 113.35 ± 42.90 | 125.77 ± 54.47 | 113.30 ± 44.16 | 127.11 ± 50.64 | 114.25 ± 40.77 | 123.20 ± 63.70 |
KHQ domain scores | ||||||||
Role limitations | 60.28 ± 26.45 | 63.59 ± 28.81 | 62.64 ± 30.75 | 60.42 ± 30.16 | 72.22 ± 29.70 | 60.32 ± 30.49 | 46.97 ± 26.69 | 60.61 ± 30.98 |
Social limitations | 45.86 ± 29.98 | 46.68 ± 31.05 | 48.85 ± 23.26 | 46.53 ± 29.39 | 50.93 ± 23.20 | 43.92 ± 30.93 | 45.45 ± 24.07 | 51.52 ± 26.89 |
OABSS total score | 11.5 ± 2.23 | 11.3 ± 1.88 | 12.1 ± 1.66 | 12.2 ± 1.80 | 12.5 ± 1.47 | 12.0 ± 1.92 | 11.5 ± 1.81 | 12.5 ± 1.57 |
AEs over 12 weeks, n (%) | (n = 94) | (n = 92) | (n = 30) | (n = 32) | (n = 19) | (n = 21) | (n = 11) | (n = 11) |
Any AE | 50 (53) | 58 (63) | 14 (47) | 18 (56) | 8 (42) | 10 (48) | 6 (55) | 8 (73) |
Urinary tract infection* | 7 (7) | 14 (15) | 2 (7) | 2 (6) | 1 (5) | 0 | 1 (9) | 2 (18) |
Nasopharyngitis | 8 (9) | 13 (14) | 3 (10) | 2 (6) | 2 (11) | 1 (5) | 1 (9) | 1 (9) |
Dysuria | 3 (3) | 10 (11) | 0 | 2 (6) | 0 | 0 | 0 | 2 (18) |
Urinary retention** | 1 (1) | 3 (3) | 1 (3) | 4 (13)*** | 0 | 0 | 1 (9) | 4 (36)*** |
Residual urine volume increased | 0 | 4 (4) | 0 | 3 (9) | 0 | 1 (5) | 0 | 2 (18) |
Cystitis | 2 (2) | 4 (4) | 0 | 0 | 0 | 0 | 0 | 0 |
Hematuria | 3 (3) | 2 (2) | 1 (3) | 1 (3) | 0 | 0 | 1 (9) | 1 (9) |
PVR urine volume category at Week 2, n (%) | (n = 94) | (n = 91) | (n = 30) | (n = 32) | (n = 19) | (n = 21) | (n = 11) | (n = 11) |
< 100 mL | 90 (96) | 71 (78) | 30 (100) | 22 (69) | 19 (100) | 17 (81) | 11 (100) | 5 (45) |
≥ 100 mL to < 200 mL | 4 (4) | 16 (18) | 0 | 7 (22) | 0 | 4 (19) | 0 | 3 (27) |
≥ 200 mL to < 350 mL | 0 | 4 (4) | 0 | 2 (6) | 0 | 0 | 0 | 2 (18) |
≥ 350 mL | 0 | 0 | 0 | 1 (3) | 0 | 0 | 0 | 1 (9) |