Table 4.
Adjusted hazard ratios for all recurrence and anatomical recurrence after Optilume drug-coated balloon use for anterior urethral strictures.
| All Recurrences | Anatomical Recurrences | |
|---|---|---|
| Characteristic | HR (95% CI, P-Value) | HR (95% CI, P-Value) |
| Age | 1.01 (0.99-1.02, P = .495) | 1.00 (0.99-1.02, P = .564) |
| BMI | 0.98 (0.94-1.02, P = .280) | 0.98 (0.94-1.02, P = .315) |
| Stricture length | ||
| L1 (< 2 cm) | - | - |
| L2 (2-7 cm) | 1.32 (0.57-3.08, P = .514) | 1.88 (0.86-4.12, P = .116) |
| L3 (> 7 cm) | 2.24 (0.29-17.09, P = .437) | 3.67 (0.36-37.30, P = .271) |
| Stricture location | ||
| S1 (Bulbar) | - | - |
| S2 (Penile) | 3.88 (0.32-47.27, P = .288) | 2.72 (0.25-28.93, P = .408) |
| S3 (Pan-urethral) | NA | NA |
| Etiology | ||
| E2 – Idiopathic | - | - |
| E1 – External trauma | 1.98 (0.68-5.82, P = .213) | 1.06 (0.38-2.98, P = .910) |
| E3a – Internal trauma | 1.34 (0.54-3.36, P = .529) | 0.67 (0.26-1.72, P = .400) |
| E3b – Recurrent stricture | 1.00 (0.40-2.49, P = .998) | 1.03 (0.45-2.35, P = .942) |
| E3c – Radiation | 0.68 (0.20-2.34, P = .537) | 0.90 (0.30-2.68, P = .852) |
| E4 - Infectious | 0.96 (0.11-8.74, P = .972) | 0.87 (0.09-8.39, P = .906) |
| E5 – Hypospadias repair | 5.21 (1.06-25.60, P = .042) | 7.92 (1.81-34.74, P = .006) |
| E6 – Lichen sclerosus | NA | NA |
| LSE stage | - | |
| 1 | - | - |
| 2 | 1.16 (0.42-3.15, P = .775) | 0.71 (0.29-1.77, P = .466) |
| 3 | 0.13 (0.01-2.07, P = .150) | 0.16 (0.01-2.24, P = .173) |
| 4 | 0.19 (0.01-2.98, P = .235) | 0.06 (0.00-1.04, P = .053) |
| 5 | NA | NA |
| Type of use | ||
| FDA-Indicated | - | - |
| Off-label | 0.90 (0.51-1.60, P = .731) | 1.08 (0.63-1.85, P = .787) |
| Pre-treatment type | ||
| None | - | - |
| Balloon dilation | 2.21 (0.55-8.83, P = .263) | 0.64 (0.18-2.31, P = .494) |
| DVIU | 1.61 (0.48-5.38, P = .439) | 1.72 (0.48-6.24, P = .407) |
| Balloon type | ||
| 30 Fr, 5 cm | - | - |
| 30 Fr, 3 cm | 1.50 (0.65-3.44, P = .339) | 0.98 (0.45-2.13, P = .969) |
| 24 Fr, 5 cm | 1.47 (0.55-3.93, P = .444) | 0.79 (0.37-1.67, P = .533) |
| 24 Fr, 3 cm | 3.64 (1.10-12.09, P = .035) | 4.58 (1.44-14.54, P = .010) |
| 18 Fr, 3 cm | NA | NA |
| Prior urethroplasty | 1.24 (0.64-2.41, P = .525) | 1.38 (0.71-2.69, P = .340) |
| Prior dilation/DVIU | 1.04 (0.58-1.86, P = .889) | 1.00 (0.57-1.78, P = .994) |
BMI, body mass index; SD, standard deviation.
Bold values highlight statistically significant findings.