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Table 1 Baseline characteristics

From: 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

 

Tadalafil OaD (N = 139)

Tadalafil PRN (N = 143)a

Placebo (N = 141)

Overall (N = 423)a

Age, years

 Mean (SD)

58.6 (5.07)

57.5 (5.91)

57.6 (5.69)

57.9 (5.58)

 <61 years, n (%)

82 (59.0)

85(59.4)

91 (64.5)

258 (61.0)

 61-68 years, n (%)

57 (41.0)

58 (40.6)

50 (35.5)

165 (39.0)

nsRP approach, n (%)

 Open surgery

68 (48.9)

65 (45.5)

56 (39.7)

189 (44.7)

 Conventional laparoscopy

29 (20.9)

31 (21.7)

28 (19.9)

88 (20.9)

 Robot-assisted laparoscopy

31 (22.3)

41 (28.7)

44 (31.2)

116 (27.4)

 Other

11 (7.9)

6 (4.2)

13 (9.2)

30 (7.1)

IIEF-EF at randomization (V4, after prostatectomy)

 N with data

137

140

137

414

 Mean (SD)

6.0 (5.80)

6.7 (5.57)

6.5 (6.08)

6.4 (5.81)

EPIC sexual domain score

 N with data

133

140

137

410

 Mean (SD)

19.8 (19.56)

21.9 (20.16)

20.1 (21.87)

20.6 (20.53)

EPIC urinary incontinence domain score

 N with data

133

139

137

409

 Mean (SD)

46.7 (30.71)

47.9 (28.89)

49.5 (28.05)

48.0 (29.17)

EPIC urinary irritative/obstructive domain score

 N with data

131

137

134

402

 Mean (SD)

78.1 (18.92)

81.5 (15.08)

81.3 (16.42)

80.4 (16.88)

EPIC bowel domain total score

 N with data

129

134

136

399

 Mean (SD)

88.3 (15.32)

91.2 (10.31)

89.9 (13.69)

89.8 (13.27)

EPIC hormonal domain score

 N with data

130

137

136

403

 Mean (SD)

90.0 (12.71)

92.0 (10.51)

91.4 (10.89)

91.2 (11.39)

  1. aData presented for all patients randomized. One patient assigned to tadalafil PRN did not receive any study drug and was therefore not included in the ITT population.
  2. Abbreviations:EPIC Expanded Prostate Cancer Index Composite (EPIC-26), IIEF-EF International Index of Erectile Function – Erectile Function, ITT intent-to-treat, N number of patients, n number of patients with characteristic, nsRP bilateral nerve-sparing prostatectomy, NSS Nelson Nerve-Sparing score, OaD once daily, PRN “pro-re-nata”/on-demand, SD standard deviation, V visit EPIC scores range from 0–100, higher scores indicate better values.