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

Tables

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)NSa
Prostate volume (mL)26.0 ± 13.8 (98)27.3 ± 14.7 (50)24.7 ± 12.9 (48)NSa
IPSS total score15.5 ± 6.0 (101)14.7 ± 5.2 (51)16.3 ± 6.7 (50)NSb
IPSS-QoL4.5 ± 0.9 (101)4.5 ± 0.9 (51)4.4 ± 1.0 (50)NSb
BPH impact index5.1 ± 2.7 (100)5.1 ± 2.7 (50)5.1 ± 2.8 (50)NSb
Voided volume (mL)170.4 ± 116.3 (70)159.5 ± 115.7 (35)181.2 ± 117.5 (35)NSb
Max flow rate (mL/s)10.6 ± 6.0 (70)10.3 ± 5.7 (35)10.9 ± 6.3 (35)NSb
Average flow rate (mL/s)5.8 ± 3.2 (69)5.8 ± 3.3 (34)5.7 ± 3.1 (35)NSb
Post void residual urine (mL)66.4 ± 77.2 (70)70.1 ± 85.7 (34)62.9 ± 69.3 (36)NSb

 

Table 2. Overall Severity
 
Criteria for overall severityGroupMildModerateSevereIntergroup P value
n(%)n(%)n(%)
Overall severity was evaluated by the criteria for treatment efficacy in BPH proposed by the Japanese Urological Association. Chi-square test.
Symptom (IPSS)Group O0(0.0)36(80.0)9(20.0)NS
Group T0(0.0)32(71.1)13(28.9)
QoL (IPSS-QoL)Group O0(0.0)22(48.9)23(51.1)NS
Group T0(0.0)25(55.6)20(44.4)
Function (Qmax)Group O9(20.9)30(69.8)4(9.3)NS
Group T9(20.9)31(72.1)3(7.0)
Overall severityGroup O1(2.2)36(80.0)8(17.8)NS
Group T2(4.7)31(72.1)10(23.3)

 

Table 3. Differences in IPSS, IPSS-QoL and BII
 
GroupNBaseline8 weeksIntragroup P valueDifference
Mean ± SD (range). Intragroup: Wilcoxon signed-rank test; intergroup: Mann-Whitney U test.
IPSS total scoreGroup O4515.0 ± 5.29.7 ± 5.0< 0.001-5.3 ± 4.7
Group T4516.8 ± 6.411.3 ± 5.0< 0.001-5.5 ± 5.6
Intergroup P valueNSNSNS
IPSS-QoLGroup O454.6 ± 0.72.9 ± 1.0< 0.001-1.8 ± 1.2
Group T454.5 ± 0.83.1 ± 1.2< 0.001-1.5 ± 1.2
Intergroup P valueNSNSNS
BII total scoreGroup O455.3 ± 2.72.7 ± 2.1< 0.001-2.6 ± 2.0
Group T455.4 ± 2.63.2 ± 2.3< 0.001-2.2 ± 2.8
Intergroup P valueNSNSNS

 

Table 4. Differences in Objective Findings
 
GroupNBaseline8 weeksIntragroup P valueDifference
Mean ± SD (range). Intragroup: Wilcoxon signed-rank test; intergroup: Mann-Whitney U test.
Voided volume (mL)Group O33162.8 ± 118.3209.4 ± 142.50.01746.6 ± 105.6
Group T33184.8 ± 119.3196.7 ± 109.4NS11.8 ± 151.6
Intergroup P valueNSNSNS
Max flow rate (mL/s)Group O3310.4 ± 5.813.0 ± 6.10.0032.5 ± 4.9
Group T3310.8 ± 6.312.3 ± 6.1NS1.5 ± 6.0
Intergroup P valueNSNSNS
Average flow rate (mL/s)Group O325.8 ± 3.47.6 ± 4.10.0031.8 ± 3.0
Group T335.7 ± 3.06.5 ± 3.7NS0.8 ± 2.8
Intergroup P valueNSNSNS
Post void residual urine (mL)Group O3260.2 ± 78.054.5 ± 91.0NS-5.7 ± 52.3
Group T3466.2 ± 69.938.2 ± 43.2NS-28.0 ± 66.9
Intergroup P valueNSNSNS

 

Table 5. Criteria for Treatment Efficacy
 
Group (n)ExcellentGoodFairPoorIntergroup P value
n(%)n(%)n(%)n(%)
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 efficacyGroup 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 6. Predictive Factors for Efficacy Using the Japanese Clinical Practice Guideline for Voiding Dysfunction
 
Odds ratio95% Confidence limitsP 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.
Age1.0771.140.98 - 1.190.99 - 1.33NSNS
PV1.031.130.93 - 1.131.02 - 1.25NS0.021
Severity of symptoms0.260.060.20 - 3.330.01 - 0.75NS0.029
Severity of QoL0.597.020.09 - 3.670.70 - 70.72NSNS
Severity of dysfunction0.301.260.06 - 1.510.18 - 8.70NSNS
Baseline BII0.070.820.73 - 1.570.51 - 1.32NSNS