Table 1.
Estimates of effectiveness of treatment (IPSS improvements), durability of effects, and transition probabilitiesa for occurrence of early and late AEs
Number of subjects included in effectiveness and safety assessments
|
Change in IPSS compared with baseline*
|
Return of LUTS (% patients)
|
|||||||
---|---|---|---|---|---|---|---|---|---|
Baseline | Year 1 | Year 2 | Year 1 | Year 2 | Reference | Per 6-month cycle | Reference | ||
ComboRx | 2,524 | 2,403 | 1,575 | ComboRx | −1.70 | −6.20 | 22,23 | 0.70 | 23 |
Rezūm® | 189 | 165 | 109 | Rezūm | −11.65 | −11.80 | 24–26 | 0.60 | 24–26 |
UroLift® | 420 | 331 | 136 | UroLift | −10.65 | −9.47 | 27–33 | 4.92 | 27–29 |
Prostiva® | 626 | 346 | 139 | Prostiva | −11.24 | −11.06 | 34–40 | 0.93 | 34,37,38,41 |
Greenlight® PVP | 2,478 | 1,185 | 432 | Greenlight PVP | −15.08 | −13.62 | 42–50 | 0.93 | 42–46,48,49,51–54 |
TURP | 539 | 429 | 302 | TURP | −16.79 | −13.06 | 33,35,36,44–46,49,54–58 | 0.31 | 44–46,49,58 |
AEs (% patients) per 6-month cycle
| |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Incontinence | De novo erectile dysfunction | Stricture, contracture, or stenosis | Acute urinary retention | Urinary tract infection | |||||||||
Therapy | Earlyb | Latec | Ref. | Early | Ref. | Early | Late | Ref. | Through Year 2 | Ref. | Early | Late | Ref. |
ComboRx | 0.07 | 0.02 | 22 | 5.38 | 59 | 0.01d | 0.01d | NA | 0.07 | 22 | 0.07 | 0.02 | 22 |
Rezūm | 0.01d | 0.01d | 24–26 | 0.01d | 24–26 | 1.13 | 0.42 | 24–26 | 0.27 | 24–26 | 1.99 | 0.43 | 24–26 |
UroLift | 1.05 | 0.97 | 27–33 | 0.01d | 27–33 | 0.01d | 0.01d | 33 | 1.31 | 26–33 | 2.17 | 0.64 | 27–33 |
Prostiva | 0.01d | 0.26 | 39 | 0.46 | 36,39 | 0.01d | 0.11 | 36–39 | 0.01d | NA | 4.77 | 1.59 | 39 |
Greenlight PVP | 4.75 | 0.01d | 42,43,45,46,52 | 0.01d | 43,45,46,60 | 1.51 | 0.61 | 43–51,53,54 | 1.30 | 43,50,51, 53,54 | 19.90e | 1.11 | 44,46,50, 51,53,54 |
TURP | 2.06 | 0.78 | 50,51,54,58,61 | 1.05 | 33,46 | 4.66 | 0.62 | 46,49–51,54,58,61 | 1.76 | 33,50, 51,54 | 12.23e | 2.09 | 33,46,50, 51,54,61 |
Notes:
A decrease (minus sign) in IPSS represents an improvement compared with baseline. A common baseline IPSS of 22 was used for comparison of the treatment modalities in the model. For the modeling, it is assumed that ComboRx is the typical first line of treatment for LUTS/BPH. Patients who have inadequate symptom relief or worsening of LUTS may progress to one of the three MIT options (0.33 assumption). Patients who progress after an MIT have two surgical options (0.5 assumption). Early AEs are those occurring within 6 months after treatment, while late AEs are those occurring 6 months or later after treatment.
Per 6-month cycle.
First 6-month cycle.
After first 6-month cycle.
When AE is not reported in any source, the rate is indicated as 0.01 for modeling purposes.
Early rates in the few papers with reports were very high.
From baseline reported in the individual papers.
Abbreviations: AE, adverse event; BPH, benign prostatic hyperplasia; ComboRx, combination prescription drug therapy; Greenlight PVP, photovaporization of the prostate; IPSS, International Prostate Symptom Score; LUTS, lower urinary tract symptoms; MIT, minimally invasive therapy; NA, not available; Prostiva, conductive radiofrequency thermal therapy; Ref., reference; Rezūm, convective radiofrequency water vapor thermal therapy; TURP, transurethral resection of the prostate; UroLift, prostatic urethral lift.