Table 1.
Baseline patient characteristics and inclusion and exclusion criteria
| Phase 1 (n = 15) | Phase 2 (n = 18) | |
|---|---|---|
| Age, yr (range) | 64 (52–82) | 66 (49–80) |
| Prior medical BPH therapy, No. (%) | 10 (67) | 4 (22) |
| Prostate volume, g (range) | 45.3 (29.8–80.8) | 51.0 (30.0–74.0) |
| Qmax, ml/s (range) | 11.4 (7.0–14.2) | 10.7 (5.0–15.5) |
| PSA level, ng/ml (range) | 2.2 (0.3–6.1) | 2.9 (0.6–8.9) |
| IPSS (range) | 19.1 (12–26) | 20.1 (15–30) |
| QoL (range) | 4.5 (3–6) | 4.5 (3–6) |
BPH = benign prostatic hyperplasia; Qmax = maximum flow rate; PSA = prostate-specific antigen; IPSS = International Prostate Symptom Score; QoL = quality of life.