Evaluation of a Progressive Treatment Program for Erectile Dysfunction in Patients with Diabetes Mellitus

S. Israilov; J. Shmuely; E. Niv; D. Engelstein; P. Livne; J. Boniel


Int J Impot Res. 2005;17(5):431-436. 

In This Article


Our team first applied a progressive treatment program for ED in diabetic patients in 1997. In 1998, the US Food and Drug Administration approved the use of sildenafil citrate (Viagra), which was then incorporated into our program, after its contraindications were clarified.[19]

In the present study, a progressive program for the treatment of ED in diabetic patients yielded a complete response for short-term and 91.2% rate of success at the end of 2 y follow-up. Sildenafil and ICI were the most common modalities.

The analysis of a group of 276 patients who received sildenafil shows that 147 (53.3%) responded positively, including nine of 37 (24.3%) receiving insulin. The rate of side effects was 9.1%. A review of the findings in the literature yielded a 62.9% positive response rate in 465 patients with DM evaluated by Carson et al,[21] and a 64.6% rate in the study of Boulton et al,[11] including 36.8% positivity among patients taking insulin. The discrepancy with our results may be explained by the high percentage of diabetic complications and comorbidities in our sample (61.1%), the older age of our sample (43.7% of the patients were in the 61-78 y age group), and the relatively high (13.4%) rate of insulin use. The rate of adverse effects in our study is in line with others.[8,9,20]

Our response rate for the VED (70.4%), as well as the percentage of patients[4,5] with pain, decreased rigidity and temperature are similar to the reports of others investigators.[17,22]

Color Doppler ultrasound in 17 patients with penile rigidity at 1-2 min after cylinder removal showed a significant difference in peak systolic and peak diastolic velocity from 5 min after ICI to 15 min after, similar to the findings of Sarteschi et al.[23]

In the present study, 143 patients received different doses of three vasoactive drugs. Using a dimix of papaverine 30 mg+phentolamine 1.5 mg in patients with DM, Bell et al[8] reported a success rate of 36.4%. Segenreich et al[9] achieved a success rate of 67.4% with papaverine+Regitine in 198 diabetic patients. The use of prostaglandin E1 for failures of the dimix yielded a 41.4% response rate. However, 30.6% of patients reported various grades of pain during erection. The remaining patients with a negative response were given all three drugs trimix, and 64.5% achieved successful coitus. Accordingly, our success rate with the ICI was 72%; after 2 y of follow-up, 39.8% of the patients were still responding to it. Our rate of pain was also high, however (46.2%). We reduced the dose of prostaglandin E1 in the patients with pain. (For this reason, the prostaglandin E1 dose is given throughout as mean±s.d.)

Sildenafil+the ICI, our phase 4, was used for the treatment of ED by McMahon et al[15] in patients who failed sildenafil alone; 47.5% had a positive response. Adverse effects of different severities occurred in 31%. Our success rate with this method was 67.5%; during follow-up, 10% of patients had adverse effects. Our higher positive response may be explained by the more effective dosage used in the present study, namely, papaverine 25 mg, phentolamine 2.0 mg, prostaglandin E1 15.4±5.6 µg. Our lower rate of adverse effects may be explained by lower mean dose of sildenafil.

Use of the ICI followed after 5-10 min by the VED was reported by Chen et al,[14] who noted a mean change in buckle pressure of 117.0±38.5 g after ICI and of 565.0±58.6 g after VED (P<0.0001). We also found the method to be highly effective, yielding a positive response in nine of 13 patients (69.2%). By the end of follow-up, however, this method was used only by two patients (22.2%), mainly because of the complexity of the method and its unsuitability for patients without a regular partner, decrease of temperature in penis especially in glands penis.

Penile implant surgery, which was successful in 15 patients in our study, including 12 (80%) in whom penile rigidity decreased after removal of the VED cylinder and three (20%) who stopped using the VED because their spouse found it uncomfortable, was also found by Carson et al[16] to yield a good response in diabetic patients. The penile prosthesis, however, is associated with a risk of infection, especially in patient receiving insulin,[24] as were six of our patients. Our high surgical success rate was probably attributable to our use of intraoperative antibiotic irrigation and extensive pre- and postoperative administration of antibiotics.

Interestingly, Grunwald et al[25] found no statistically significant change in the retinal vasculature in 15 otherwise healthy men aged 39±8 y using the highest dose (100 mg) of sildenafil citrate on a voluntary basis. Nevertheless, we did not want to risk giving the drug to our eight patients with retinopathy and hypertension. Two of them (25%) responded to the VED, and six to the ICI.

Of the 17 patients who reported spontaneous erections at follow-up, 11 (64.7%) patients had mild-moderate ED before the start of the treatment, and six had moderate ED. None had comorbidities, all were less than 60 y old, and all were married. In all, 12 of them (70.6%) had received the ICI and five (29.4%) sildenafil citrate during the treatment period.

In conclusion, the stepwise, progressive treatment program for ED in patients with mild-to-severe DM proved seems to be very effective yielding in a complete response for short-term and 91.2% rate of success at the end of 2 y follow-up. The more complex, invasive treatments (phases 3-6) were needed mainly by patients taking insulin or with comorbid diseases. Most of the patients who failed to respond on follow-up were older (aged 70-78 y) and had other diseases besides diabetes.

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