Topical treatment of erectile dysfunction: randomised double blind placebo controlled trial of cream containing aminophylline, isosorbide dinitrate, and co-dergocrine mesylate

Gomaa, Adel A.; Shalaby, Mohamed; Osman, Mahmoud M.; Eissa, Mohamed Abdelaziz; Eizat, Alaa; Mahmoud, Mostafy; Mikhail, Nabiel

doi:10.1136/bmj.312.7045.1512

Cited by 33 publications

(12 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Of these, 21 reported full erection and satisfactory intercourse without major adverse effects. 71 However, this positive result was not confirmed by others. 72 …”

Section: Nitroglycerincontrasting

confidence: 40%

Current status of local penile therapy

et al. 2002

View full text Add to dashboard Cite

Guidelines for management of patients with erectile dysfunction indicate that intraurethral and intracavernosal injection therapies represent the second-line treatment available. Efficacy of intracavernosal injections seems superior to that of the intraurethral delivery of drugs, and this may explain the current larger diffusion of the former modality. Safety of these two therapeutic options is well established; however, the attrition rate with these approaches is significant and most patients eventually drop out of treatment. Newer agents with better efficacy-safety profiles and using user-friendly devices for drug administration may potentially increase the long-term satisfaction rate achieved with these therapies. Topical therapy has the potential to become a firstline treatment for erectile dysfunction because it acts locally and is easy to use. At this time, however, the crossing of the barrier caused by the penile skin and tunica albuginea has limited the efficacy of the drugs used.

show abstract

“…Of these, 21 reported full erection and satisfactory intercourse without major adverse effects. 71 However, this positive result was not confirmed by others. 72 …”

Section: Nitroglycerincontrasting

confidence: 40%

Current status of local penile therapy

et al. 2002

View full text Add to dashboard Cite

show abstract

“…16 Currently available treatments for ED have a number of disadvantages, including need for needles, rejection of external devices by younger patients and, in the case of available oral remedies, either lack of rigor in establishing effectiveness or limited efficacy. 17 While novel treatments currently being evaluated include topical vasodilators, 18 it is clear that an effective oral treatment for ED that works only during sexual stimulation would represent a convenient and attractive alternative therapy. Recent advances in the understanding of the mechanisms underlying the physiology of penile erection and pathophysiology of ED highlight the role of NO-induced cGMP production in corporal smooth muscle relaxation.…”

Section: Discussionmentioning

confidence: 99%

Sildenafil: study of a novel oral treatment for erectile dysfunction in diabetic men

et al. 1998

View full text Add to dashboard Cite

The efficacy and safety of oral sildenafil, a potent inhibitor of phosphodiesterase type 5, were evaluated in men with diabetes mellitus and erectile dysfunction (ED). Twenty-one men (aged 42-65 years) were enrolled in a double-blind, placebo-controlled, three-way crossover study conducted in two parts. In part I, the effect of a single dose (25 mg or 50 mg) of sildenafil or placebo on penile rigidity was assessed by penile plethysmography during visual sexual stimulation. In part II, daily diary records of erectile activity and a global efficacy question were used to evaluate once-daily dosing with 25 mg or 50 mg of sildenafil or placebo for 10 days. After a single 50 mg dose of sildenafil, the adjusted geometric mean duration (min) of penile rigidity >60% at the base of the penis during visual sexual stimulation was significantly increased (10.1 min) compared with placebo (2.8 min; p = 0.0053). In part II, sildenafil significantly increased the number of erections considered sufficiently hard for vaginal penetration compared with placebo (p = 0.0005). Improved erections were reported by 50% and 52% of patients treated with 25 mg and 50 mg of sildenafil, respectively, compared with 10% of those receiving placebo (p values < 0.05). Adverse events were mostly mild or moderate in nature and included muscular pains, headache, and dyspepsia. Sildenafil is a well-tolerated and potentially efficacious oral treatment for ED in men with diabetes mellitus.

show abstract

“…Organic nitrates, minoxidil, aminophyilline, co-dergocrine mesylate, and vasoactive intestinal polypeptide have been previously described as topical cavernosal smooth muscle relaxants with different degrees of success and side-effect rates. [16][17][18][19] Recently, McVary et al compared the systemic effects, local tolerance, and effectiveness of topical gel formulations of PGE 1 and SEPA applied to the penile shaft and glans of men with spinal cord injuries. They reported that PGE 1 gel generated an erectile response in 67-75% of men compared to 17% in controls.…”

Section: Discussionmentioning

confidence: 99%

Feline penile erection induced by topical glans penis application of combination alprostadil and SEPA (Topiglan)

2004

View full text Add to dashboard Cite

The objective of this study was to evaluate the efficacy of topically applied prostaglandin E1 (PGE 1 ) þ 5% SEPA (soft enhancement of percutaneous absorption) on the glans penis in a feline erection model. Erectile response after glans penis administration of PGE 1 þ 5% SEPA cream (Topiglan, MacroChem Co., Lexington, MA, USA) was compared to the erectile response after intracavernosal administration of the triple-drug combination (1.65 mg papaverine, 25 lg phentolamine, and 0.5 lg PGE 1 ). The placebo cream and increasing concentrations (0.25%, 2.5 mg/ml; 0.5%, 5 mg/ml; and 1%, 10 mg/ml) of PGE 1 þ 5% SEPA were applied in a total volume of 0.1 ml via a plastic needle-less syringe. The control triple-drug combination was administrated intracavernosally via a 30-gauge needle at the completion of each experiment to serve as a control reference. With each application of placebo, PGE 1 þ SEPA, and the triple-drug combination, changes in intracavernosal pressure and systemic blood pressure were continuously monitored. Topical application of PGE 1 þ SEPA induced increases in intracavernosal pressure in a dosedependent manner, with minimal effects on systemic blood pressure. The increases obtained with 1% PGE 1 Topiglan cream were similar to the intracavernosal pressure values elicited by the standard intracavernosal triple-drug combination. These data demonstrate that topical glans penis application of PGE 1 þ SEPA can induce an erectile response in cats with minimal systemic adverse effects. Oral pharmacological agents are the first-line treatment for male ED. Studies investigating the effectiveness of noninvasive modalities such as topical therapy should continue, because these agents have the potential to avoid the systemic effects commonly seen with oral therapies. Additionally, topical therapy may also benefit patients who are unresponsive to oral agents or have explicit contraindications. Topical PGE 1 application to the glans penis may become an important treatment option in selected patients suffering from erectile dysfunction.

show abstract

Topical treatment of erectile dysfunction: randomised double blind placebo controlled trial of cream containing aminophylline, isosorbide dinitrate, and co-dergocrine mesylate

Abstract: Topical treatment with a cream containing three different vasodilators might be considered before intracavernous injection of vasoactive agents, particularly in psychogenic impotence.

Cited by 33 publications

References 21 publications

Current status of local penile therapy

Current status of local penile therapy

Sildenafil: study of a novel oral treatment for erectile dysfunction in diabetic men

Feline penile erection induced by topical glans penis application of combination alprostadil and SEPA (Topiglan)

Contact Info

Product

Resources

About