Treatment satisfaction among men with concurrent benign prostatic hyperplasia and erectile dysfunction treated with tadalafil or other phosphodiesterase type-5 inhibitor combinations

Figures & data

Table 1 Patient demographics and characteristics

	Once-daily tadalafil only (n=113)		Tadalafil combination (n=184)		PDE5-I combination (n=210)		Total (N=507)
Age, years (mean, SD)	56.7*,#	9.00	60.5*	10.1	64.3	9.55	61.2	10.1
Ethnicity
White (%, n)	81.4%	92	85.3%	157	84.8%	178	84.2%	427
Black (%, n)	1.8%	2	1.1%	2	1.4%	3	1.4%	7
African-American (%, n)	0.9%	1	1.1%	2	4.3%	9	2.4%	12
Asian or Pacific Islander (%, n)	5.3%*	6	2.2%	4	1.4%	3	2.6%	13
Native American or Alaskan native (%, n)	0.0%‡	0	1.6%	3	1.9%	4	1.4%	7
Mixed racial background (%, n)	0.0%‡	0	1.1%	2	1.0%	2	0.8%	4
Other (%, n)	0.0%‡	0	0.0%‡	0	1.0%	2	0.4%	2
Declined to answer (%, n)	10.6%*	12	7.6%	14	4.3%	9	6.9%	35
Education
<4-year degree (%, n)	42.5%	48	37.5%	69	39.5%	83	39.4%	200
4-year college degree or higher (%, n)	57.5%	65	62.5%	115	60.5%	127	60.6%	307
Annual household income
<US$25,000 (%, n)	3.5%	4	6.5%	12	7.6%	16	6.3%	32
US$25,000 to <50,000 (%, n)	17.7%	20	16.3%	30	13.8%	29	15.6%	79
US$50,000 to <75,000 (%, n)	19.5%	22	20.7%	38	25.2%	53	22.3%	113
≥US$75,000 (%, n)	57.5%	65	52.2%	96	51.9%	109	53.3%	270
Declined to answer (%, n)	1.8%	2	4.3%	8	1.4%	3	2.6%	13
CCI score (mean, SD)	0.240*	0.909	0.410	0.883	0.600	1.170	0.454	1.03
BMI category
Underweight (%, n)	0.9%	1	0.0%‡	0	1.4%	3	0.8%	4
Normal weight (%, n)	21.2%	24	18.5%	34	26.2%	55	22.3%	113
Overweight (%, n)	37.2%	42	47.3%	87	42.9%	90	43.2%	219
Obese (%, n)	40.7%*	46	34.2%	63	29.5%	62	33.7%	171
Exercise 20+ minutes in past month
Exercise: 0–11 times (%, n)	57.5%	65	47.3%	87	52.9%	111	51.9%	263
Exercise: 12+ times (%, n)	42.5%	48	52.7%	97	47.1%	99	48.1%	244
Baseline bladder emptying severity (mean, SD)	1.86*,#	0.35	1.70	0.46	1.71	0.45	1.74	0.44
Baseline bladder storage severity (mean, SD)	1.82	0.38	1.82	0.39	1.76	0.43	1.79	0.41
Baseline ED severity (mean, SD)	1.96	0.21	1.92	0.27	1.92	0.27	1.93	0.26

Notes: Presented in each column are results from two-sample comparisons using binomial proportion tests or t-tests for categorical and continuous variables, respectively. Treatment groups: once-daily tadalafil only (tadalafil for BPH and ED), tadalafil combination (tadalafil for ED with 5-ARIs and/or alpha blockers for BPH), PDE5-I combination (non-tadalafil PDE5-I for ED with 5-ARIs and/or alpha blockers for BPH). Variables of conceptual interest are included in the table, as are a subset of all variables collected in the study.

* P<0.05 for differences between the value shown and the value in PDE5-I combination, within a given row.

# P<0.05 for differences between the value shown and the value in tadalafil combination, within a given row.

‡ This category was not analyzed in pair-wise comparisons because its value was equal to 0 or 1.

Abbreviations: SD, standard deviation; BMI, body mass index; BPH, benign prostatic hyperplasia; CCI, Charlson comorbidity index; ED, erectile dysfunction; PDE5-I, phosphodiesterase type-5 inhibitor.

Table 2 Treatment duration

	Once-daily tadalafil only (n=113)		Tadalafil combination (n=184)		PDE5-I combination (n=210)		Total (N=507)
	Mean	SD	Mean	SD	Mean	SD	Mean	SD
Tadalafil for BPH	2.20	2.43	2.11	1.82	–	–	2.17	2.26
5-ARIs	–	–	0.58	0.36	0.68	0.40	0.64	0.38
Alpha blockers	–	–	4.25	4.17	5.91	5.97	5.10	5.23
PDE5-I	–	–	–	–	5.79	4.83	5.79	4.83
Tadalafil as needed for ED	–	–	5.07	5.75	–	–	5.07	5.75
Tadalafil daily for ED	2.11	1.76	2.33	1.76	–	–	2.21	1.76

Notes: Presented as mean years on treatment. “–” indicates there was no data.

Abbreviations: SD, standard deviation; PDE5-I, phosphodiesterase type-5 inhibitor; BPH, benign prostatic hyperplasia; 5-ARI, 5-alpha-reductase inhibitors; ED, erectile dysfunction.

Table 3 Treatment satisfaction

	Once-daily tadalafil only (n=113)		Tadalafil combination (n=184)		PDE5-I combination (n=210)		Total (N=507)
EDITS total score (mean, SD)	80.2*,#	16.8	70.0	23.3	66.3	22.5	70.8	22.3
TSQM-9 effectiveness: ED treatment (mean, SD)	70.0*,#	19.9	60.8	21.9	56.5	22.9	61.1	22.4
TSQM-9 convenience: ED treatment (mean, SD)	83.1*,#	16.8	74.7*	18.2	68.6	18.5	74.1	18.9
TSQM-9 global satisfaction: ED treatment (mean, SD)	71.1*,#	21.1	60.7*	23.0	54.4	25.5	60.4	24.5
TSQM-9 effectiveness: BPH treatment (mean, SD)	69.0*,#	19.2	60.7	19.7	58.0	22.1	61.5	21.0
TSQM-9 convenience: BPH treatment (mean, SD)	82.5*,#	16.8	78.1#	17.0	76.7	20.1	78.5	18.4
TSQM-9 global satisfaction: BPH treatment (mean, SD)	70.3*,#	21.2	61.8	22.3	57.6	25.5	61.9	23.9
How easy or difficult is it to plan when you will use the medication(s) (both BPH and ED) each time?
Extremely difficult (%, n)	0.0%‡	0	0.5%	1	0.0%‡	0	0.2%	1
Very difficult (%, n)	0.0%‡	0	0.0%‡	0	1.9%	4	0.8%	4
Difficult (%, n)	0.9%*	1	3.3%	6	6.7%	14	4.1%	21
Somewhat easy (%, n)	11.5%*	13	19.6%	36	25.2%	53	20.1%	102
Easy (%, n)	15.9%*	18	23.9%	44	28.6%	60	24.1%	122
Very easy (%, n)	33.6%*	38	28.8%	53	22.9%	48	27.4%	139
Extremely easy (%, n)	38.1%*,#	43	23.9%*	44	14.8%	31	23.3%	118
Mean (mean, SD)	6.00*,#	1.00	5.00*	1.00	5.00	1.00	5.00	1.00
How convenient or inconvenient is it to take the medication(s) (both BPH and ED) as instructed?
Extremely inconvenient (%, n)	0.0%‡	0	0.5%	1	0.5%	1	0.4%	2
Very inconvenient (%, n)	0.0%‡	0	0.0%‡	0	1.9%	4	0.8%	4
Inconvenient (%, n)	2.7%	3	1.6%	3	4.8%	10	3.2%	16
Somewhat convenient (%, n)	5.3%*,#	6	19.0%	35	22.4%	47	17.4%	88
Convenient (%, n)	22.1%	25	22.8%	42	27.1%	57	24.5%	124
Very convenient (%, n)	31.0%	35	30.4%	56	23.3%	49	27.6%	140
Extremely convenient (%, n)	38.9%*,#	44	25.5%	47	20.0%	42	26.2%	133
Mean (mean, SD)	6.00*,#	1.00	6.00*	1.00	5.00	1.00	6.00	1.00

Notes: Presented in each column are results from two-sample comparisons using binomial proportion tests or t-tests for categorical and continuous variables, respectively. Treatment groups: once-daily tadalafil only (tadalafil for BPH and ED), tadalafil combination (tadalafil for ED with 5-ARIs and/or alpha blockers for BPH), PDE5-I combination (non-tadalafil PDE5-I for ED with 5-ARIs and/or alpha blockers for BPH).

* P<0.05 for differences between the value shown and the value in PDE5-I combination, within a given row.

# P<0.05 for differences between the value shown and the value in tadalafil combination, within a given row.

‡ This category was not analyzed in pair-wise comparisons because its value was equal to zero or one.

Abbreviations: SD, standard deviation; BPH, benign prostatic hyperplasia; ED, erectile dysfunction; EDITS, Erectile Dysfunction Inventory of Treatment Satisfaction; PDE5-I, phosphodiesterase type-5 inhibitor; TSQM-9, Treatment Satisfaction Questionnaire for Medication; 5-ARI, 5-alpha-reductase inhibitors.

Table 4 BPH and ED treatment satisfaction as a function of potential predictors

Predictors	TSQM-9 global: BPH b (95% LCI, UCI)	TSQM-9 global: ED b (95% LCI, UCI)	EDITS: ED b (95% LCI, UCI)	Ease of planning: BPH and ED b (95% LCI, UCI)	Convenience: BPH and ED b (95% LCI, UCI)
Once-daily tadalafil only	12.3* (6.88, 17.8)	15.0* (9.43, 20.5)	11.0* (6.10, 15.9)	0.991* (0.709, 1.27)	0.837* (0.552, 1.12)
Tadalafil combination	3.78 (−0.793, 8.35)	5.46* (0.835, 10.1)	2.25 (−1.88, 6.38)	0.457* (0.221, 0.694)	0.385* (0.146, 0.624)
Age	−0.353* (−0.580, −0.127)	−0.390* (−0.620, −0.161)	−0.544* (−0.748, −0.339)	0.010 (−0.002, 0.021)	0.008 (−0.004, 0.019)
CCI score	0.89 (−1.10, 2.87)	−0.432 (−2.44, 1.58)	−0.242 (−2.03, 1.55)	0.022 (−0.081, 0.125)	0.030 (−0.073, 0.134)
Education: <4-year degree	1.05 (−3.48, 5.59)	−2.87 (−7.46, 1.72)	−1.66 (−5.75, 2.44)	0.092 (−0.143, 0.327)	0.141 (−0.096, 0.378)
Exercise: 0–11 times a month	0.091 (−4.03, 4.21)	2.12 (−2.05, 6.29)	0.284 (−3.43, 4.00)	0.122 (−0.091, 0.335)	0.042 (−0.173, 0.257)
Ethnicity: Hispanic	−8.70 (−18.0, 0.631)	−6.91 (−16.4, 2.54)	−0.581 (−9.01, 7.85)	0.008 (−0.475, 0.492)	0.147 (−0.340, 0.635)
ED baseline severity	−4.46* (−6.91, −2.01)	−3.48* (−5.96, −0.992)	−4.61* (−6.82, −2.39)	−0.059 (−0.186, 0.068)	−0.065 (−0.193, 0.063)
BPH baseline severity	1.26 (−0.930, 3.45)	1.66 (−0.559, 3.88)	1.16 (−0.817, 3.14)	0.034 (−0.079, 0.148)	0.010 (−0.105, 0.124)
Income: <US$25,000	9.18* (0.555, 17.8)	5.90 (−2.83, 14.6)	5.23 (−2.55, 13.0)	0.345 (−0.101, 0.792)	0.084 (−0.366, 0.534)
Income: US$25,000 to <50,000	−2.85 (−8.94, 3.25)	0.333 (−5.84, 6.51)	0.411 (−5.09, 5.92)	−0.062 (−0.378, 0.254)	−0.217 (−0.536, 0.101)
Income: US$50,000 to <75,000	−1.42 (−6.51, 3.67)	−1.19 (−6.34, 3.97)	−0.730 (−5.33, 3.87)	−0.110 (−0.374, 0.153)	−0.157 (−0.423, 0.108)
Income: declined to answer	0.092 (−12.6, 12.7)	0.478 (−12.3, 13.3)	−5.34 (−16.8, 6.08)	0.091 (−0.564, 0.746)	−0.245 (−0.906, 0.415)
BMI: underweight	−20.4 (−43.1, 2.38)	−18.3 (−41.4, 4.68)	−8.95 (−29.5, 11.6)	−0.571 (1.75, 0.606)	−0.635 (−1.82, 0.552)
BMI: overweight	−6.00* (−11.2, −0.836)	−7.59* (−12.8, −2.36)	−5.30* (−9.97, −0.634)	−0.113 (−0.381, 0.154)	−0.093 (−0.363, 0.177)
BMI: obese	−9.98* (−15.5, −4.42)	−10.8* (−16.4, −5.14)	−9.74* (−14.8, −4.73)	−0.309* (−0.597, −0.021)	−0.358* (−0.648, −0.068)

Notes: Presented in each column are the results of a single regression model predicting the outcome as a function of all predictors listed in the rows. Treatment groups: once-daily tadalafil only (tadalafil for BPH and ED), tadalafil combination (tadalafil for ED with 5-ARIs and/or alpha blockers for BPH), PDE5-I combination (non-tadalafil PDE5-I for ED with 5-ARIs and/or alpha blockers for BPH). Treatment reference group: PDE5-I combination. Patient characteristics reference groups: ethnicity, non-Hispanic; education, 4-year or more degree; exercise, 12+ times a month; BMI, normal weight; income, ≥US$75,000.

* P<0.05, two-tailed.

Abbreviations: b, unstandardized beta coefficient; LCI, lower confidence interval; UCI, upper confidence interval; BMI, body mass index; CCI, Charlson comorbidity index; BPH, benign prostatic hyperplasia; ED, erectile dysfunction; EDITS, Erectile Dysfunction Inventory of Treatment Satisfaction; TSQM-9, Treatment Satisfaction Questionnaire for Medication; 5-ARI, 5-alpha-reductase inhibitors.

Table 5 Health-related quality of life by treatment group (as assessed at time of survey)

	Once-daily tadalafil only (n=113)		Tadalafil combination (n=184)		PDE5-I combination (n=210)		Total (N=507)
I-PSS total (higher scores, greater severity) (mean, SD)	16.0	8.59	16.8	8.18	15.3	7.98	16.0	8.20
SHIM total (lower scores, greater severity) (mean, SD)	14.7*	5.70	12.6	6.20	13.5	6.00	13.4	6.05
I-PSS QoL: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?
Delighted (%, n)	3.5%	4	0.5%	1	1.0%	2	1.4%	7
Pleased (%, n)	4.4%	5	4.9%	9	5.2%	11	4.9%	25
Mostly satisfied (%, n)	14.2%	16	13.6%	25	20.0%	42	16.4%	83
Mixed (%, n)	23.9%	27	26.6%	49	29.5%	62	27.2%	138
Mostly dissatisfied (%, n)	22.1%	25	20.7%	38	21.0%	44	21.1%	107
Unhappy (%, n)	19.5%	22	20.1%	37	15.7%	33	18.1%	92
Terrible (%, n)	12.4%	14	13.6%	25	7.6%	16	10.8%	55
Jenkins sleep questionnaire total (mean, SD)	13.6	5.41	13.7	4.93	13.2	5.00	13.5	5.06

Notes: Presented in each column are results from two-sample comparisons using binomial proportion tests or t-tests for categorical and continuous variables, respectively. Treatment groups: once-daily tadalafil only (tadalafil for BPH and ED), tadalafil combination (tadalafil for ED with 5-ARIs and/or alpha blockers for BPH), PDE5-I combination (non-tadalafil PDE5-I for ED with 5-ARIs and/or alpha blockers for BPH).

* P<0.05 for differences between the value shown and the value in tadalafil combination, within a given row.

Abbreviations: SD, standard deviation; PDE5-I, phosphodiesterase type-5 inhibitor; SHIM, Sexual Health Inventory for Men; BPH, benign prostatic hyperplasia; ED, erectile dysfunction; I-PSS, International Prostate Symptom Score; QoL, quality of life; 5-ARI, 5-alpha-reductase inhibitors.