Effect of combination treatment on patient-related outcome measures in benign prostatic hyperplasia: clinical utility of dutasteride and tamsulosin

Figures & data

Table 1 International Prostate Symptom Score questionnaire

In the past month	Not at all	Less than 1 in 5 times	Less than half of the time	About half of the time	More than half of the time	Almost always	Your score
1. Incomplete emptying	0	1	2	3	4	5
How often have you had the sensation of not emptying your bladder?
2. Frequency	0	1	2	3	4	5
How often have you had to urinate less than every 2 hours?
3. Intermittency	0	1	2	3	4	5
How often have you found you stopped and started again several times when you urinated?
4. Urgency	0	1	2	3	4	5
How often have you found it difficult to postpone urination?
5. Weak stream	0	1	2	3	4	5
How often have you had a weak urinary stream?
6. Straining	0	1	2	3	4	5
How often have you had to strain to start urination?
	None	1 time	2 times	3 times	4 times	5 times	Your score
7. Nocturia	0	1	2	3	4	5
How many times did you typically get up at night to urinate?
Total IPSS score
Quality of life due to urinary symptoms	Delighted	Pleased	Mostly satisfied	Mixed-equally satisfied and dissatisfied	Mostly dissatisfied	Unhappy	Terrible
If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?	0	1	2	3	4	5	6

Notes: Total IPSS score: 0–7 mildly symptomatic; 8–19 moderately symptomatic; 20–35 severely symptomatic.

Abbreviation: IPPS, International Prostate Symptom Score.

Table 2 Benign Prostatic Hypertrophy Impact Index questionnaire

1. During the last month, how much physical discomfort did any urinary problems cause you?
None (0)	Only a little (1)	Some (2)	A lot (3)
2. During the last month, how much did you worry about your health because of any urinary problems?
None (0)	Only a little (1)	Some (2)	A lot (3)
3. Overall, how bothersome has any trouble with urination been during the last month?
Not at all (0)	A little (1)	Some (2)	A lot (3)
4. During the last month, how much of the time has any urinary problem kept you from doing the kinds of things you would usually do?
None (0)	A little (1)	Some of the time (2)	Most of the time (3)	All the time (4)

Table 3 Patient Perception of Satisfaction with Medication questionnaire

0	1	2	3	4	5	6
1. Since you began taking the study medication, how has control of your urinary problems changed?
Much improved	Improved	Somewhat improved	No change	Somewhat worse	Worse	Much worse
2. How satisfied are you with the effect of the study medication on control of your urinary problems?
Very satisfied	Satisfied	Somewhat satisfied	Neutral	Somewhat dissatisfied	Dissatisfied	Very dissatisfied
3. Since you began taking the study medication, how has the strength of your urinary stream changed?
Much improved	Improved	Somewhat improved	No change	Somewhat worse	Worse	Much worse
4. How satisfied are you with the effect of the study medication on the strength of your urinary stream?
Very satisfied	Satisfied	Somewhat satisfied	Neutral	Somewhat dissatisfied	Dissatisfied	Very dissatisfied
5. Since you began taking the study medication, how has your pain prior to urinating changed?
Much improved	Improved	Somewhat improved	No change	Somewhat worse	Worse	Much worse
6. How satisfied are you with the effect the study medication has on your pain prior to urinating?
Very satisfied	Satisfied	Somewhat satisfied	Neutral	Somewhat dissatisfied	Dissatisfied	Very dissatisfied
7. Since you began taking the study medication, how has your pain during urination changed?
Much improved	Improved	Somewhat improved	No change	Somewhat worse	Worse	Much worse
8. How satisfied are you with the effect the study medication has on your pain during urination?
Very satisfied	Satisfied	Somewhat satisfied	Neutral	Somewhat dissatisfied	Dissatisfied	Very dissatisfied
9. Since you began taking the study medication, how has the way your urinary problems interfere with your ability to go about your usual activities changed?
Much improved	Improved	Somewhat improved	No change	Somewhat worse	Worse	Much worse
10. How satisfied are you with the effect the study medication has on your ability to go about your usual activities without interference with your usual activities?
Very satisfied	Satisfied	Somewhat satisfied	Neutral	Somewhat dissatisfied	Dissatisfied	Very dissatisfied
11. Overall, how satisfied are you with the study medication and its effect on your urinary problems?
Very satisfied	Satisfied	Somewhat satisfied	Neutral	Somewhat dissatisfied	Dissatisfied	Very dissatisfied
12. Would you ask your doctor for the medication you received in this study?
Yes	No	Not sure

Table 4 Results of trials on efficacy of combination therapy with an α-blocker and a 5α-reductase inhibitor

Reference	Duration (weeks)	Intervention (n)	Symptom change (% IPSS)	Change in Qmax (mL/sec)	Change in TPV (%)
Lepor et al^Citation47	52	Placebo (n = 305)	−16.5^a	+1.4	+1.3
		Terazosin 10 mg/day (n = 305)	−37.7^Table Footnotea,Table Footnoteb,Table Footnoted	+2.7^Table Footnoteb,Table Footnoted	+1.3
		Finasteride 5 mg/day (n = 310)	−19.8^a	+1.6	−16.9
		Combination therapy (n = 309)	−39^Table Footnotea,Table Footnoteb,Table Footnoted	+3.2^Table Footnoteb,Table Footnoted	−18.8^Table Footnoteb,Table Footnotec
Debruyne et al^Citation48	26	Alfuzosin 5 mg bid (n = 358)	−41.2^d	+1.8	−0.5
		Finasteride 5 mg/day (n = 344)	−33.5	+1.8	−10.5^c
		Combination therapy (n = 349)	−39^d	+2.3	−11.9^c
Kirby et al^Citation49	52	Placebo (n = 253)	−33.1	+1.4	−
		Doxazosin 1–8 mg/day (n = 250)	−49.1^Table Footnoteb,Table Footnoted	+3.6^Table Footnoteb,Table Footnoted	–
		Finasteride 5 mg/day (n = 239)	−38.6	+1.8	–
		Combination therapy (n = 265)	−49.7^Table Footnoteb,Table Footnoted	+3.8^d	–
McConnell et al^Citation38	234	Placebo (n = 737)	−23.8^a	+1.4^a	+24^a
		Doxazosin 1–8 mg/day (n = 756)	−35.3^Table Footnotea,Table Footnoteb,Table Footnoted	+2.5^Table Footnotea,Table Footnoteb	+24^a
		Finasteride 5 mg/day (n = 768)	−28.4^Table Footnotea,Table Footnoteb	+2.2^Table Footnotea,Table Footnoteb	−19^Table Footnotea–Table Footnotec
		Combination therapy (n = 786)	−41.7^Table Footnotea–Table Footnoted	+3.7^Table Footnotea–Table Footnoted	−19^Table Footnotea–Table Footnotec
Roehrborn et al^Citation50	104	Tamsulosin 0.4 mg/day (n = 1611)	−27.4	+0.9	0
		Dutasteride 0.5 mg/day (n = 1623)	−30.5	+1.9	−28^c
		Combination therapy (n = 1610)	−39.2^Table Footnotec,Table Footnoted	+2.4^Table Footnotec,Table Footnoted	−26.9^c
Roehrborn et al^Citation40	208	Tamsulosin 0.4 mg/day (n = 1611)	−23.2	+0.7	+4.6
		Dutasteride 0.5 mg/day (n = 1623)	−32.3	+2.0	−28^c
		Combination therapy (n = 1610)	−38^Table Footnotec,Table Footnoted	+2.4^c	−27.3^c

Notes:

a Significant compared with baseline;

b Significant compared with placebo;

c Significant compared with α-blocker monotherapy;

d Significant compared with 5α-reductase inhibitor monotherapy.

Abbreviations: Q_max, maximal urinary flow rate; IPSS, International Prostate Symptom Score; TPV, total prostate volume.

LeporHWillifordWOBarryMJThe efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study GroupN Engl J Med19963355335398684407

 PubMed Web of Science ®Google Scholar

DebruyneFMJardinAColloiDSustained-release alfuzosin, finasteride and the combination of both in the treatment of benign prostatic hyperplasia. European ALFIN Study GroupEur Urol1998341691759732187

 PubMed Web of Science ®Google Scholar

KirbyRSA randomized, double-blind crossover study of tamsulosin and controlled-release doxazosin in patients with benign prostatic hyperplasiaBJU Int200391414412614248

 PubMed Web of Science ®Google Scholar

McConnellJDRoehrbornCGBautistaOMThe long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasiaN Engl J Med20033492387239814681504

 PubMed Web of Science ®Google Scholar

RoehrbornCGSiamiPBarkinJThe effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT studyJ Urol200817961662118082216

 PubMed Web of Science ®Google Scholar

RoehrbornCGSiamiPBarkinJThe effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT studyEur Urol20105712313119825505

 PubMed Web of Science ®Google Scholar