Combined on-demand sildenafil citrate and tramadol hydrochloride is an effective and safe treatment for premature ejaculation: A randomized placebo-controlled double-blind clinical trial

Figures & data

Table 1. The main pre-treatment group characteristics.

Variable	Group	Mean	SD	Minimum	Maximum	Range
Age	P	31.32	6.59	22	46	24
	S	32.13	7.15	22	48	26
	T	32.17	7	22	48	46
	S+T	32.55	7.16	23	48	25
Marriage duration	P	3.24	1.63	1	7	6
	S	3.49	1.97	1	8	7
	T	3.57	2.26	1	9	8
	S+T	3.48	2.21	1	9	8
Pre-treatment IELT	P	62.24	14.04	32	90
	S	65.08	16.59	32	102	70
	T	65	16.42	33	100	67
	S+T	64.98	17.04	32	100	68

Table 2. Kruskal Wallis test (SS = satisfaction score).

Variable	Mean rank (sum of all freq. of all pt.)				Kruskal–Wallis H
	P	S	T	S+T
Intercourse frequency/week	84.07	88.91	78.82	61.34	9.178
Pre-treatment SS	74.59	78.68	82.51	75.50	1.081
Age	73.65	77.95	78.71	81.00	0.511
Marriage duration in years	77.01	79.54	78.44	76.88	0.095

Table 3. Kruskal Wallis test (SS = satisfaction score).

Variable	Mean rank				Kruskal–Wallis H
	P	S	T	S+T
Post-treatment IELT	17.69	55.46	96.55	131.76	135.763
Post-treatment SS	21.38	53.95	108.64	117.40	1.081

Table 4. The difference between the mean pre-treatment and post-treatment IELT/satisfaction score results among treatment groups.

Wilcoxon signed ranks test
Variable	Group	Mean		p
		Pre-treatment	Post-treatment
IELT	P	62.24	66.44	0.0001
	S	65.08	146.33	0.0001
	T	65.00	300.57	0.0001
	S+T	64.98	519.45	0.0001
Satisfaction Score	P	0.59	0.59	1
	S	0.64	1.95	0.0001
	T	0.69	3.76	0.0001
	S+T	0.60	3.97	0.0001

Table 5. Treatment side-effects distribution among treatment groups.

Side effect	Group			Total (n = 155)
	Sildenafil citrate (n = 39)	Tramadol HCl (n = 42)	Combination (n = 40)
Difficult urination	-	4/42 (9.52%)	-	4/155 (2.58%)
Blurred vision	1/39 (2.56%)	3/42 (7.14%)	4/40 (10%)	8/155 (5.16%)
Dizziness	1/39 (2.56%)	3/42 (7.14%)	3/40 (7.5%)	7/155 (4.52%)
Constipation	-	3/42 (7.14%)	-	3/155 (1.94%)
Dyspepsia	3/39 (7.69%)	-	3/40 (7.5%)	6/155 (3.87%)
Nausea	1/39 (2.56%)	2/42 (4.76%)	3/40 (7.5%)	6/155 (3.87%)
Headache	4/39 (10.26%)	-	1/40 (2.5%)	5/155 (3.23%)
Flushing	4/39 (10.26%)	-	2/40 (5%)	6/155 (3.87%)
Nasal congestion	3/39 (7.69%)	-	2/40 (5%)	5/155 (3.23)
No. of Patients	7/39 (17.95%)	8/42 (19.05%)	8/40 (20%)	23/155 (14.84%)

Table 6. Different drugs used in previous studies.

Study	Used drugs	Satisfaction score	IELT/sec.	Side effects	P value
Salonia et al. [49]	Paroxetine with sildenafil	Improved to 9	-	Increased	<0.05
Gameel et al. [20]	Tramadol, Sildenafil, Paroxetine, and Local Anaesthetics	-	119, 111, 65 respectively	Minimal	<0.05
Hosseini et al. [44]	Fluoxetine with sildenafil	Improved to 9	-	Tolarable	<0.05
Our study	Tramadol with sildenafil	Improved to 9	519	Minimal	<0.0001

Salonia A, Maga T, Colombo R, et al. A prospective study comparing paroxetine alone versus paroxetine plus sildenafil in patients with premature ejaculation. J Urol. 2002;168(6):2486–2489. doi: 10.1016/S0022-5347(05)64174-2

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Gameel TA, Tawfik AM, Abou-Farha MO, et al. On-demand use of tramadol, sildenafil, paroxetine and local anaesthetics for the management of premature ejaculation: a randomised placebo-controlled clinical trial. Arab J Urol. 2013;11(4):392–397. doi: 10.1016/j.aju.2013.05.003

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Hosseini MM, Yarmohammadi H. Effect of fluoxetine alone and in combination with sildenafil in patients with premature ejaculation. Urol Int. 2007;79(1):28–32. doi: 10.1159/000102909

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