Effects of tadalafil treatment after bilateral nerve-sparing radical prostatectomy: quality of life, psychosocial outcomes, and treatment satisfaction results from a randomized, placebo-controlled phase IV study

Table 2 LS mean changes [95%CI] in EPIC domain scores from baseline

	Tadalafil OaD (N = 139)	Tadalafil PRN (N = 142)	Placebo (N = 141)
EPIC sexual domain (age-group by treatment interaction: p = 0.083) ^a
End of DBT	+27.5 [21.6, 33.4]**	+20.7 [15.3, 26.1]	+18.0 [12.1, 23.8]
End of OLT	+36.6 [30.0, 43.1]	+32.6 [26.6, 38.6]	+33.4 [27.0, 39.8]
Men ≤60 years	+30.1 [23.2, 36.9]	+31.2 [24.8, 37.6]	+24.9 [18.2, 31.6]
Men 61–68 years	+34.0 [26.0, 42.0]	+22.1 [14.6, 29.5]	+26.5 [18.5, 34.4]
EPIC urinary incontinence domain (age-group by treatment interaction: p = 0.084) ^a
End of DBT	+34.1 [29.3, 38.9]	+31.1 [26.7, 35.5]	+30.6 [25.9, 35.3]
End of OLT	+37.4 [32.6, 42.3]	+35.5 [31.1, 40.0]	+35.4 [30.7, 40.2]
Men ≤60 years	+33.0 [27.7, 38.3]	+34.6 [29.6, 39.7]	+35.8 [30.5, 41.1]
Men 61–68 years	+38.5 [32.2, 44.8]*	+32.0 [26.2, 37.9]	+30.2 [24.0, 36.5]
EPIC urinary irritative/obstructive domain
End of DBT	+13.8 [11.5, 16.1]	+13.3 [11.2, 15.4]	+12.3 [10.0, 14.5]
End of OLT	+13.9 [11.5, 16.2]	+13.8 [11.7, 15.9]	+12.3 [10.0, 14.6]
EPIC bowel domain
End of DBT	+5.9 [3.7, 8.2]	+6.3 [4.2, 8.3]	+6.5 [4.3, 8.7]
End of OLT	+6.9 [4.7, 9.1]	+6.5 [4.5, 8.5]	+6.8 [4.6, 8.9]
EPIC hormonal domain
End of DBT	+1.7 [−0.8, 4.3]	+2.7 [0.4, 5.1]*	−0.2 [−2.7, 2.3]
End of OLT	+2.5 [0.1, 4.9]	+2.9 [0.8, 5.1]	+3.0 [0.7, 5.4]

**p < 0.01, *p < 0.05 versus placebo (MMRM).
^aSignificant at the 10% level.
Abbreviations:CI confidence interval, DBT double-blind treatment, EPIC Expanded Prostate Cancer Index Composite (EPIC-26), LS mean least squares mean, MMRM mixed model for repeated measures, N number of patients in the ITT population, OaD once daily, OLT open-label treatment, PRN “pro-re-nata”/on-demand.
Data are from MMRM, including baseline domain score, treatment, country, visit, visit-by-treatment interaction, and age group (men ≤60 years, men 61–68 years) (combined sexual/ incontinence score: additionally adjusted for body mass index, smoking status, nerve-sparing score, and type of surgery [open, conventional, robot-assisted, other]). Age-group-by-treatment interaction was included only if significant at the 10% level. For men ≤60 years and 61–68 years (data shown in italics), the overall treatment effect presented includes all visits from baseline to end of OLT.

ISSN: 1471-2490