World J Nephrol Urol

World Journal of Nephrology and Urology, ISSN 1927-1239 print, 1927-1247 online, Open Access

Article copyright, the authors; Journal compilation copyright, World J Nephrol Urol and Elmer Press Inc

Journal website http://www.wjnu.org

Original Article

Volume 3, Number 2, June 2014, pages 72-82

A Randomized Study Comparing Once-Daily and Thrice-Daily Naftopidil 75 mg/Day for Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia

**Table 1.** Baseline Characteristics of the Two Groups
	Total (n)	Group O (n)	Group T (n)	Intergroup P value
Mean ± SD. ^aUnpaired t-test; ^bMann-Whitney U test.
Age (years)	69.4 ± 8.2 (101)	68.5 ± 8.3 (51)	70.4 ± 8.0 (50)	NS^a
Prostate volume (mL)	26.0 ± 13.8 (98)	27.3 ± 14.7 (50)	24.7 ± 12.9 (48)	NS^a
IPSS total score	15.5 ± 6.0 (101)	14.7 ± 5.2 (51)	16.3 ± 6.7 (50)	NS^b
IPSS-QoL	4.5 ± 0.9 (101)	4.5 ± 0.9 (51)	4.4 ± 1.0 (50)	NS^b
BPH impact index	5.1 ± 2.7 (100)	5.1 ± 2.7 (50)	5.1 ± 2.8 (50)	NS^b
Voided volume (mL)	170.4 ± 116.3 (70)	159.5 ± 115.7 (35)	181.2 ± 117.5 (35)	NS^b
Max flow rate (mL/s)	10.6 ± 6.0 (70)	10.3 ± 5.7 (35)	10.9 ± 6.3 (35)	NS^b
Average flow rate (mL/s)	5.8 ± 3.2 (69)	5.8 ± 3.3 (34)	5.7 ± 3.1 (35)	NS^b
Post void residual urine (mL)	66.4 ± 77.2 (70)	70.1 ± 85.7 (34)	62.9 ± 69.3 (36)	NS^b

Table 1. Baseline Characteristics of the Two Groups

Total (n)

Group O (n)

Group T (n)

Intergroup P value

Mean ± SD. ^aUnpaired t-test; ^bMann-Whitney U test.

Age (years)

69.4 ± 8.2 (101)

68.5 ± 8.3 (51)

70.4 ± 8.0 (50)

NS^a

Prostate volume (mL)

26.0 ± 13.8 (98)

27.3 ± 14.7 (50)

24.7 ± 12.9 (48)

NS^a

IPSS total score

15.5 ± 6.0 (101)

14.7 ± 5.2 (51)

16.3 ± 6.7 (50)

NS^b

IPSS-QoL

4.5 ± 0.9 (101)

4.5 ± 0.9 (51)

4.4 ± 1.0 (50)

NS^b

BPH impact index

5.1 ± 2.7 (100)

5.1 ± 2.7 (50)

5.1 ± 2.8 (50)

NS^b

Voided volume (mL)

170.4 ± 116.3 (70)

159.5 ± 115.7 (35)

181.2 ± 117.5 (35)

NS^b

Max flow rate (mL/s)

10.6 ± 6.0 (70)

10.3 ± 5.7 (35)

10.9 ± 6.3 (35)

NS^b

Average flow rate (mL/s)

5.8 ± 3.2 (69)

5.8 ± 3.3 (34)

5.7 ± 3.1 (35)

NS^b

Post void residual urine (mL)

66.4 ± 77.2 (70)

70.1 ± 85.7 (34)

62.9 ± 69.3 (36)

NS^b

**Table 2.** Overall Severity
Criteria for overall severity	Group	Mild	Moderate	Severe	Intergroup P value
Overall severity was evaluated by the criteria for treatment efficacy in BPH proposed by the Japanese Urological Association. Chi-square test.
Symptom (IPSS)	Group O	0	(0.0)	36	(80.0)	9	(20.0)	NS
	Group T	0	(0.0)	32	(71.1)	13	(28.9)
QoL (IPSS-QoL)	Group O	0	(0.0)	22	(48.9)	23	(51.1)	NS
	Group T	0	(0.0)	25	(55.6)	20	(44.4)
Function (Qmax)	Group O	9	(20.9)	30	(69.8)	4	(9.3)	NS
	Group T	9	(20.9)	31	(72.1)	3	(7.0)
Overall severity	Group O	1	(2.2)	36	(80.0)	8	(17.8)	NS
	Group T	2	(4.7)	31	(72.1)	10	(23.3)

Table 2. Overall Severity

Criteria for overall severity

Group

Mild

Moderate

Severe

Intergroup P value

(%)

Overall severity was evaluated by the criteria for treatment efficacy in BPH proposed by the Japanese Urological Association. Chi-square test.

Symptom (IPSS)

Group O

(0.0)

(80.0)

(20.0)

Group T

(0.0)

(71.1)

(28.9)

QoL (IPSS-QoL)

Group O

(0.0)

(48.9)

(51.1)

Group T

(0.0)

(55.6)

(44.4)

Function (Qmax)

Group O

(20.9)

(69.8)

(9.3)

Group T

(20.9)

(72.1)

(7.0)

Overall severity

Group O

(2.2)

(80.0)

(17.8)

Group T

(4.7)

(72.1)

(23.3)

**Table 3.** Differences in IPSS, IPSS-QoL and BII
	Group	N	Baseline	8 weeks	Intragroup P value	Difference
Mean ± SD (range). Intragroup: Wilcoxon signed-rank test; intergroup: Mann-Whitney U test.
IPSS total score	Group O	45	15.0 ± 5.2	9.7 ± 5.0	< 0.001	-5.3 ± 4.7
	Group T	45	16.8 ± 6.4	11.3 ± 5.0	< 0.001	-5.5 ± 5.6
	Intergroup P value	NS	NS		NS
IPSS-QoL	Group O	45	4.6 ± 0.7	2.9 ± 1.0	< 0.001	-1.8 ± 1.2
	Group T	45	4.5 ± 0.8	3.1 ± 1.2	< 0.001	-1.5 ± 1.2
	Intergroup P value	NS	NS		NS
BII total score	Group O	45	5.3 ± 2.7	2.7 ± 2.1	< 0.001	-2.6 ± 2.0
	Group T	45	5.4 ± 2.6	3.2 ± 2.3	< 0.001	-2.2 ± 2.8
	Intergroup P value	NS	NS		NS

Table 3. Differences in IPSS, IPSS-QoL and BII

Group

Baseline

8 weeks

Intragroup P value

Difference

Mean ± SD (range). Intragroup: Wilcoxon signed-rank test; intergroup: Mann-Whitney U test.

IPSS total score

Group O

15.0 ± 5.2

9.7 ± 5.0

< 0.001

-5.3 ± 4.7

Group T

16.8 ± 6.4

11.3 ± 5.0

< 0.001

-5.5 ± 5.6

Intergroup P value

IPSS-QoL

Group O

4.6 ± 0.7

2.9 ± 1.0

< 0.001

-1.8 ± 1.2

Group T

4.5 ± 0.8

3.1 ± 1.2

< 0.001

-1.5 ± 1.2

Intergroup P value

BII total score

Group O

5.3 ± 2.7

2.7 ± 2.1

< 0.001

-2.6 ± 2.0

Group T

5.4 ± 2.6

3.2 ± 2.3

< 0.001

-2.2 ± 2.8

Intergroup P value

**Table 4.** Differences in Objective Findings
	Group	N	Baseline	8 weeks	Intragroup P value	Difference
Mean ± SD (range). Intragroup: Wilcoxon signed-rank test; intergroup: Mann-Whitney U test.
Voided volume (mL)	Group O	33	162.8 ± 118.3	209.4 ± 142.5	0.017	46.6 ± 105.6
	Group T	33	184.8 ± 119.3	196.7 ± 109.4	NS	11.8 ± 151.6
	Intergroup P value	NS	NS		NS
Max flow rate (mL/s)	Group O	33	10.4 ± 5.8	13.0 ± 6.1	0.003	2.5 ± 4.9
	Group T	33	10.8 ± 6.3	12.3 ± 6.1	NS	1.5 ± 6.0
	Intergroup P value	NS	NS		NS
Average flow rate (mL/s)	Group O	32	5.8 ± 3.4	7.6 ± 4.1	0.003	1.8 ± 3.0
	Group T	33	5.7 ± 3.0	6.5 ± 3.7	NS	0.8 ± 2.8
	Intergroup P value	NS	NS		NS
Post void residual urine (mL)	Group O	32	60.2 ± 78.0	54.5 ± 91.0	NS	-5.7 ± 52.3
	Group T	34	66.2 ± 69.9	38.2 ± 43.2	NS	-28.0 ± 66.9
	Intergroup P value	NS	NS		NS

Table 4. Differences in Objective Findings

Group

Baseline

8 weeks

Intragroup P value

Difference

Mean ± SD (range). Intragroup: Wilcoxon signed-rank test; intergroup: Mann-Whitney U test.

Voided volume (mL)

Group O

162.8 ± 118.3

209.4 ± 142.5

0.017

46.6 ± 105.6

Group T

184.8 ± 119.3

196.7 ± 109.4

11.8 ± 151.6

Intergroup P value

Max flow rate (mL/s)

Group O

10.4 ± 5.8

13.0 ± 6.1

0.003

2.5 ± 4.9

Group T

10.8 ± 6.3

12.3 ± 6.1

1.5 ± 6.0

Intergroup P value

Average flow rate (mL/s)

Group O

5.8 ± 3.4

7.6 ± 4.1

0.003

1.8 ± 3.0

Group T

5.7 ± 3.0

6.5 ± 3.7

0.8 ± 2.8

Intergroup P value

Post void residual urine (mL)

Group O

60.2 ± 78.0

54.5 ± 91.0

-5.7 ± 52.3

Group T

66.2 ± 69.9

38.2 ± 43.2

-28.0 ± 66.9

Intergroup P value

**Table 5.** Criteria for Treatment Efficacy
	Group (n)	Excellent	Good	Fair	Poor	Intergroup P value
Treatment efficacy was evaluated by the criteria for treatment efficacy in BPH proposed by the Japanese Urological Association. Overall efficacy was the median of the efficacy grades of three items: symptoms, QoL and function. Chi-square test.
Symptom (IPSS)	Group O (45)	4	(8.9)	10	(22.2)	14	(31.1)	17	(37.8)	NS
	Group T (45)	1	(2.2)	8	(17.8)	19	(42.2)	17	(37.8)
QoL (IPSS-QoL)	Group O (45)	4	(8.9)	7	(15.6)	29	(64.4)	5	(11.1)	NS
	Group T (45)	1	(2.2)	7	(15.6)	28	(62.2)	9	(20.0)
Function (Qmax)	Group O (33)	0	(0.0)	10	(30.3)	5	(15.2)	18	(54.5)	NS
	Group T (33)	1	(3.0)	9	(27.3)	4	(12.1)	19	(57.6)
Overall efficacy	Group O (37)	1	(2.7)	8	(21.6)	16	(43.2)	12	(32.4)	NS
	Group T (39)	0	(0.0)	5	(12.8)	20	(51.3)	14	(35.9)

Table 5. Criteria for Treatment Efficacy

Group (n)

Excellent

Good

Fair

Poor

Intergroup P value

(%)

Treatment efficacy was evaluated by the criteria for treatment efficacy in BPH proposed by the Japanese Urological Association. Overall efficacy was the median of the efficacy grades of three items: symptoms, QoL and function. Chi-square test.

Symptom (IPSS)

Group O (45)

(8.9)

(22.2)

(31.1)

(37.8)

Group T (45)

(2.2)

(17.8)

(42.2)

(37.8)

QoL (IPSS-QoL)

Group O (45)

(8.9)

(15.6)

(64.4)

(11.1)

Group T (45)

(2.2)

(15.6)

(62.2)

(20.0)

Function (Qmax)

Group O (33)

(0.0)

(30.3)

(15.2)

(54.5)

Group T (33)

(3.0)

(27.3)

(12.1)

(57.6)

Overall efficacy

Group O (37)

(2.7)

(21.6)

(43.2)

(32.4)

Group T (39)

(0.0)

(12.8)

(51.3)

(35.9)

**Table 6.** Predictive Factors for Efficacy Using the Japanese Clinical Practice Guideline for Voiding Dysfunction
	Odds ratio	95% Confidence limits	P value
Logistic regression analysis.
Age	1.077	1.14	0.98 - 1.19	0.99 - 1.33	NS	NS
PV	1.03	1.13	0.93 - 1.13	1.02 - 1.25	NS	0.021
Severity of symptoms	0.26	0.06	0.20 - 3.33	0.01 - 0.75	NS	0.029
Severity of QoL	0.59	7.02	0.09 - 3.67	0.70 - 70.72	NS	NS
Severity of dysfunction	0.30	1.26	0.06 - 1.51	0.18 - 8.70	NS	NS
Baseline BII	0.07	0.82	0.73 - 1.57	0.51 - 1.32	NS	NS

Table 6. Predictive Factors for Efficacy Using the Japanese Clinical Practice Guideline for Voiding Dysfunction

Odds ratio

95% Confidence limits

P value

Group O (n = 37)

Group T (n = 39)

Group O (n = 37)

Group T (n = 39)

Group O (n = 37)

Group T (n = 39)

Logistic regression analysis.

Age

1.077

1.14

0.98 - 1.19

0.99 - 1.33

1.03

1.13

0.93 - 1.13

1.02 - 1.25

0.021

Severity of symptoms

0.26

0.06

0.20 - 3.33

0.01 - 0.75

0.029

Severity of QoL

0.59

7.02

0.09 - 3.67

0.70 - 70.72

Severity of dysfunction

0.30

1.26

0.06 - 1.51

0.18 - 8.70

Baseline BII

0.07

0.82

0.73 - 1.57

0.51 - 1.32