MP35: Sexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy I
MP35-07: Comparison of Three Different Tadalafil Regimes for the Treatment of Erectile Dysfunction in Diabetes Mellitus Patients with Microvascular Complications
Introduction: We aimed to compare the efficacy and safety of daily, on-demand and daily plus optional tadalafil use in patients with microvascular complications due to diabetes mellitus (DM) and erectile dysfunction (ED).
Methods: Patients who came to our urology outpatient clinic with ED between May 2018 and March 2020, those with at least one microvascular complication due to DM (retinopathy, nephropathy, neuropathy or diabetic foot without macrovascular complications) were selected. Those with an international erectile function index score (IIEF-5) below 11 (severe and moderate) were included in the study. The patients were divided into three groups; the first group 5 mg tadalafil (Cialis™, Lilly, USA) daily, the second group 20 mg tadalafil (Cialis™, Lilly, USA) twice a week two hours before intercourse, and the third group 5 mg tadalafil daily and 2 hours before intercourse twice a week was formed to take an extra 15 mg (20 mg total on the intercourse day) tadalafil. The IIEF-5 form filled with at the first admission. The IIEF-5, SEP-2, SEP-3, GAQ-1 and GAQ-2 inquiry forms were filled 3 months after the treatment.
Results: A total of 60 patients, 20 in each group, were included in the study. The mean age, body mass index and baseline IIEF-5 scores of the patients were similar. In the post-treatment IIEF-5 scores, the third group (13+4.7) was significantly higher than the first (8.35+2.6) (p=0.001) and the second group (10+3.6) (p= 0.035); there was no significant difference between the first and second groups (p=0.345). Although the percentage of positive answers to SEP-2 and GAQ-1 questions was different between the groups, this difference was not statistically significant. However, the percentage of patients who answered positively to the questions SEP-3 (20%, 40% and 75%, respectively) (p=0.002) and GAQ-2 (20%, 45%, and 75%, respectively) (p=0.002) was significant higher in the third group. There was no difference in the incidence of side effects between the groups (p= 0.392).
Daily
On-Demand
Daily plus on-demand
P value
Patients number (n)
20
20
20
Mean age± sd (years)
60.2+6.4
59.4+6.1
60.9+7.5
0.781
Mean BMI± sd (kg/m²)
31.8+3.65
31.7+3.7
31.8+3.72
0.999
Mean pre-treatment IIEF± sd
6.15+1.18
6.45+1.28
6.35+1.27
0.74
Mean post-treatment IIEF± sd
8.35+2.6
10+3.6
13+4.7
0.001
Mean difference in IIEF± sd
2.2+2.1
3.5+2.6
6.65+3.78
<0.001
Positive answer to SEP-2 (%)
45
65
80
0.07
Positive answer to SEP-3 (%)
20
40
75
0.002
Positive answer to GAQ-1 (%)
45
55
80
0.067
Positive answer to GAQ-2 (%)
20
45
75
0.002
Adverse event (%)
2 (10)
5 (25)
4 (20)
0.392
Table: Patients’ details.
Conclusions: Treatment of ED with oral tadalafil in patients with DM-related microvascular complications is ineffective when given daily or before intercourse. In these patients, giving the combination in the first step can provide higher efficacy and patient satisfaction with the same safety.
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