J Clin Med Res

Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc

Journal website http://www.jocmr.org

Original Article

Volume 11, Number 7, July 2019, pages 495-500

Efficacy of Naftopidil as a Medical Expulsive Therapy in Japanese Men With Ureteral Stones: A Prospective Randomized Controlled Study

**Table 1.** Patient Characteristics and Clinical Outcomes in the Four Treatment Groups
	Group	P value
The difference of each group compared with analgesic only group was shown in analyzed patients, patient age, stone size, stone location and duration of passage. *Analgesics only versus naftopidil group. NS: not significant; SD: standard deviation.
Randomized patients (n)	125	125	125	125
Withdrawal patients (n)	38	39	44	44
Self-withdrawal	18	18	18	20
Side effect	1	1	2	1
Extracorporeal shock-wave lithotripsy	12	13	15	14
Ureteral stent	5	6	7	6
Hospital change	1	0	1	2
Treatment of other diseases	1	1	1	1
Analyzed patients (n)	87	86	81	81	NS
Age, years, mean (SD)	48.3 (12.5)	45.7 (13.6)	48.8 (10.9)	45.9 (10.8)	NS
Stone size, mm, mean (SD)	5.1 (1.6)	5.1 (1.9)	5.1 (1.8)	4.9 (1.9)	NS
Stone location (n)
Right/left	40/47	33/53	42/39	33/48	NS
Proximal	27	42	33	33	NS
Middle	6	6	5	4	NS
Distal	54	38	43	44	NS
Duration of passage, days, mean (SD)	20.0 (9.8)	22.6 (9.3)	16.8 (9.9)*	17.8 (10.3)	NS *0.040
Proximal	23.5 (8.7)	25.2 (8.1)	20.1 (10.4)	19.5 (10.5)	NS
Middle	27.3 (6.5)	24.0 (9.4)	24.2 (7.3)	23.3 (7.3)	NS
Distal	17.4 (9.7)	19.5 (9.9)	13.4 (8.6)*	16.0 (10.2)	NS *0.041

Table 1. Patient Characteristics and Clinical Outcomes in the Four Treatment Groups

Group

P value

Analgesics only

Quercus salicina + flopropione

Naftopidil

Quercus salicina + flopropione + naftopidil

The difference of each group compared with analgesic only group was shown in analyzed patients, patient age, stone size, stone location and duration of passage. *Analgesics only versus naftopidil group. NS: not significant; SD: standard deviation.

Randomized patients (n)

125

Withdrawal patients (n)

Self-withdrawal

Side effect

Extracorporeal shock-wave lithotripsy

Ureteral stent

Hospital change

Treatment of other diseases

Analyzed patients (n)

Age, years, mean (SD)

48.3 (12.5)

45.7 (13.6)

48.8 (10.9)

45.9 (10.8)

Stone size, mm, mean (SD)

5.1 (1.6)

5.1 (1.9)

5.1 (1.8)

4.9 (1.9)

Stone location (n)

Right/left

40/47

33/53

42/39

33/48

Proximal

Middle

Distal

Duration of passage, days, mean (SD)

20.0 (9.8)

22.6 (9.3)

16.8 (9.9)*

17.8 (10.3)

NS *0.040

Proximal

23.5 (8.7)

25.2 (8.1)

20.1 (10.4)

19.5 (10.5)

Middle

27.3 (6.5)

24.0 (9.4)

24.2 (7.3)

23.3 (7.3)

Distal

17.4 (9.7)

19.5 (9.9)

13.4 (8.6)*

16.0 (10.2)

NS *0.041

**Table 2.** Cox Proportional Hazards Model: Multivariate Analysis for the Probability of Overall Stone Expulsion in Each Ureteral Position
	Hazard ratio	95% CI	P value
A: analgesics only. B: daily doses of 240 mg flopropione and 1,350 mg QS. C: daily dose of 50 mg naftopidil. D: daily dose of 240 mg flopropione, 1,350 mg QS and 50 mg naftopidil. CI: confidence interval; NS: not significant.
Whole ureter
A vs. B	0.638	0.429 - 0.948	0.0262
A vs. C	1.426	1.000 - 2.033	0.0497
B vs. C	2.183	1.475 - 3.229	< 0.0001
A vs. D	1.267	0.886 - 1.814	NS
B vs. D	1.962	1.323 - 2.910	0.0008
Proximal
A vs. B	0.766	0.348 - 1.687	NS
A vs. C	1.805	0.870 - 3.746	NS
B vs. C	2.403	1.220 - 4.733	0.0113
A vs. D	1.915	0.928 - 3.953	NS
B vs. D	2.542	1.298 - 4.979	0.0065
Middle
A vs. B	1.158	0.163 - 8.238	NS
A vs. C	2.259	0.371 - 13.76	NS
B vs. C	1.650	0.275 - 9.906	NS
A vs. D	3.283	0.523 - 20.60	NS
B vs. D	2.170	0.360 - 13.08	NS
Distal
A vs. B	0.708	0.437 - 1.146	NS
A vs. C	1.555	1.013 - 2.388	0.0440
B vs. C	2.064	1.249 - 3.409	0.0047
A vs. D	1.082	0.699 - 1.675	NS
B vs. D	1.494	0.901 - 2.478	NS

Table 2. Cox Proportional Hazards Model: Multivariate Analysis for the Probability of Overall Stone Expulsion in Each Ureteral Position

Hazard ratio

95% CI

P value

A: analgesics only. B: daily doses of 240 mg flopropione and 1,350 mg QS. C: daily dose of 50 mg naftopidil. D: daily dose of 240 mg flopropione, 1,350 mg QS and 50 mg naftopidil. CI: confidence interval; NS: not significant.

Whole ureter

A vs. B

0.638

0.429 - 0.948

0.0262

A vs. C

1.426

1.000 - 2.033

0.0497

B vs. C

2.183

1.475 - 3.229

< 0.0001

A vs. D

1.267

0.886 - 1.814

B vs. D

1.962

1.323 - 2.910

0.0008

Proximal

A vs. B

0.766

0.348 - 1.687

A vs. C

1.805

0.870 - 3.746

B vs. C

2.403

1.220 - 4.733

0.0113

A vs. D

1.915

0.928 - 3.953

B vs. D

2.542

1.298 - 4.979

0.0065

Middle

A vs. B

1.158

0.163 - 8.238

A vs. C

2.259

0.371 - 13.76

B vs. C

1.650

0.275 - 9.906

A vs. D

3.283

0.523 - 20.60

B vs. D

2.170

0.360 - 13.08

Distal

A vs. B

0.708

0.437 - 1.146

A vs. C

1.555

1.013 - 2.388

0.0440

B vs. C

2.064

1.249 - 3.409

0.0047

A vs. D

1.082

0.699 - 1.675

B vs. D

1.494

0.901 - 2.478

**Table 3.** Cox Proportional Hazards Model: Multivariate Analysis for the Probability of Expulsion of Stones < 6 mm in Each Ureteral Position
	Hazard ratio	95% CI	P value
A: analgesics only. B: daily doses of 240 mg flopropione and 1,350 mg QS. C: daily dose of 50 mg naftopidil. D: daily dose of 240 mg flopropione, 1,350 mg QS and 50 mg naftopidil. CI: confidence interval; NS: not significant.
Whole ureter
A vs. B	0.751	0.477 - 1.183	NS
A vs. C	1.570	1.039 - 2.374	0.0329
B vs. C	2.000	1.270 - 3.150	0.0028
A vs. D	1.145	0.759 - 1.727	NS
B vs. D	1.513	0.963 - 2.377	NS
Proximal
A vs. B	0.704	0.271 - 1.825	NS
A vs. C	1.617	0.707 - 3.698	NS
B vs. C	2.363	0.999 - 5.586	NS
A vs. D	1.385	0.622 - 3.085	NS
B vs. D	2.028	0.881 - 4.670	NS
Distal
A vs. B	0.775	0.453 - 1.328	NS
A vs. C	1.778	1.066 - 2.965	0.0275
B vs. C	2.105	1.190 - 3.724	0.0105
A vs. D	1.115	0.672 - 1.849	NS
B vs. D	1.396	0.793 - 2.456	NS

Table 3. Cox Proportional Hazards Model: Multivariate Analysis for the Probability of Expulsion of Stones < 6 mm in Each Ureteral Position

Hazard ratio

95% CI

P value

Whole ureter

A vs. B

0.751

0.477 - 1.183

A vs. C

1.570

1.039 - 2.374

0.0329

B vs. C

2.000

1.270 - 3.150

0.0028

A vs. D

1.145

0.759 - 1.727

B vs. D

1.513

0.963 - 2.377

Proximal

A vs. B

0.704

0.271 - 1.825

A vs. C

1.617

0.707 - 3.698

B vs. C

2.363

0.999 - 5.586

A vs. D

1.385

0.622 - 3.085

B vs. D

2.028

0.881 - 4.670

Distal

A vs. B

0.775

0.453 - 1.328

A vs. C

1.778

1.066 - 2.965

0.0275

B vs. C

2.105

1.190 - 3.724

0.0105

A vs. D

1.115

0.672 - 1.849

B vs. D

1.396

0.793 - 2.456

**Table 4.** Cox Proportional Hazards Model: Multivariate Analysis for the Probability of Expulsion of Stones > 6 mm in Each Ureteral Position
	Hazard ratio	95% CI	p value
A: analgesics only. B: daily doses of 240 mg flopropione and 1,350 mg QS. C: daily dose of 50 mg naftopidil. D: daily dose of 240 mg flopropione, 1,350 mg QS and 50 mg naftopidil. CI: confidence interval; NS: not significant.
Whole ureter
A vs. B	0.514	0.228 - 1.159	NS
A vs. C	1.345	0.662 - 2.732	NS
B vs. C	2.621	1.197 - 5.735	0.0159
A vs. D	1.518	0.732 - 3.148	NS
B vs. D	2.961	1.325 - 6.617	0.0081
Proximal
A vs. B	1.465	0.296 - 7.261	NS
A vs. C	2.683	0.541 - 13.30	NS
B vs. C	1.894	0.610 - 5.881	NS
A vs. D	2.855	0.521 - 15.64	NS
B vs. D	2.007	0.565 - 7.133	NS
Distal
A vs. B	0.486	0.157 - 1.511	NS
A vs. C	1.316	0.564 - 3.073	NS
B vs. C	2.641	0.822 - 8.493	NS
A vs. D	1.009	0.425 - 2.400	NS
B vs. D	2.107	0.648 - 6.857	NS

Table 4. Cox Proportional Hazards Model: Multivariate Analysis for the Probability of Expulsion of Stones > 6 mm in Each Ureteral Position

Hazard ratio

95% CI

p value

Whole ureter

A vs. B

0.514

0.228 - 1.159

A vs. C

1.345

0.662 - 2.732

B vs. C

2.621

1.197 - 5.735

0.0159

A vs. D

1.518

0.732 - 3.148

B vs. D

2.961

1.325 - 6.617

0.0081

Proximal

A vs. B

1.465

0.296 - 7.261

A vs. C

2.683

0.541 - 13.30

B vs. C

1.894

0.610 - 5.881

A vs. D

2.855

0.521 - 15.64

B vs. D

2.007

0.565 - 7.133

Distal

A vs. B

0.486

0.157 - 1.511

A vs. C

1.316

0.564 - 3.073

B vs. C

2.641

0.822 - 8.493

A vs. D

1.009

0.425 - 2.400

B vs. D

2.107

0.648 - 6.857