Erectile dysfunction (ED) is defined as the persistent inability to attain and maintain an erection sufficient to permit satisfactory sexual performance.¹ The development of phosphodiesterase 5 inhibitors (PDE5i) has been a significant breakthrough in ED management.² Although this holds true, there is currently a scarcity of data from double- or triple-blind multicenter studies comparing the effectiveness and patient preferences regarding the most commonly used PDE5i (sildenafil, tadalafil, vardenafil, and avanafil).² Moreover, the selection of a suitable PDE5i relies on various factors, such as sexual activity frequency (intermittent or regular, 3-4 times per week) and personal experience. Treatment choices should be even more tailored for younger patients with ED, especially toward those with primary psychogenic ED.³ In this regard, research has shown that 1 out of 4 patients seeking initial medical help for new-onset ED are under 40 years old, with half of these men displaying symptoms indicative of severe ED, further emphasizing the need for proper treatment counselling for these individuals.⁴ Among all PDE5i, daily tadalafil provides a valuable alternative to on-demand PDE5i for couples who prefer spontaneous to scheduled sexual intercourse.⁵ To address the specific needs of this younger demographic and explore the potential benefits of daily tadalafil, our study focused on evaluating erectile function (EF) recovery, after treatment discontinuation in this specific population. More specifically, we aimed to assess the rate and the clinical factors associated with EF recovery after discontinuation of daily 5 mg tadalafil in a cohort of young men seeking first medical help for ED as their primary complaint.

The study involved the complete data analysis of 96 consecutive young patients (less than 50 years) seeking first medical help for ED and prescribed with daily 5 mg tadalafil at a single academic center. Health-significant comorbidities were scored using the Charlson Comorbidity Index (CCI). Patients completed the International Index of Erectile Function (IIEF) at baseline and were followed up with clinical assessment or phone interviews. EF recovery was defined as IIEF-EF >22 after discontinuation of daily 5 mg tadalafil. Patients without EF recovery were classified as tadalafil nonresponders. Descriptive statistics was used to compare clinical and sociodemographic characteristics between responders and nonresponders. Cox regression hazard models tested the association between patients’ baseline characteristics and the risk of EF recovery after discontinuing daily 5 mg tadalafil. Kaplan-Meier analyses estimated the probability of EF recovery over time.

Table 1 shows the baseline characteristics of the whole cohort and the differences between tadalafil nonresponders vs tadalafil responders after discontinuation of tadalafil 5 mg once daily (OaD). The median (IQR) age of the participants was 39 (32-45) years. Among the patients, 82 (85.4%) achieved EF recovery at the time of tadalafil discontinuation, while 14 (14.6%) were identified as nonresponders. The median (IQR) tadalafil usage time (from beginning to interruption) was 3 (2-11) months. The most common adverse effect reported was headache, affecting 9 (9.4%) patients. Nonresponders were older (43 vs 38, P = .03), had higher BMI (25.5 vs 23.6, P = .04), and reported lower baseline IIEF-EF scores (12 vs 15, P = .02) than tadalafil responders. There were no differences in baseline severe ED (IIEF-EF <11), comorbidities (CCI ≥1), or smoking and alcohol consumption between the 2 groups. According to the Cox regression analysis, younger age (HR: 0.95; 95% CI: 0.92-0.99, P = .01) was associated with EF recovery after adjusting for baseline severe EF, BMI, smoking, and CCI ≥1 (Table 2). The probability of EF recovery over time is displayed in the Figure. Lastly, Table 3 shows the Kaplan-Meier estimates of EF recovery after discontinuation of tadalafil 5 mg OaD estimates. More specifically, at 3, 6, and 12 months, 42 (43%), 57 (60%), and 70 (72%) patients achieved full EF recovery, respectively.

Table 1. Sociodemographic, Clinical and Hormonal Characteristics of the Whole Cohort of Patients and Those Who Were Tadalafil Responders vs Nonresponders After Discontinuation of Tadalafil 5 mg Once Daily

Table 2. Multivariate Cox Regression Analysis Predicting Erectile Function Recovery After Discontinuation of Tadalafil 5 Mg Once Daily

Table 3. Kaplan-Meier Estimates of Erectile Function Recovery After Discontinuation of Tadalafil 5 Mg Once Daily

The results of this study demonstrate that almost 1 out of 2 young ED patients prescribed with daily 5 mg tadalafil achieve full EF recovery within 3 months of treatment. Younger patients have a higher probability of EF recovery with daily 5 mg tadalafil therapy.

These findings suggest that age is a crucial factor affecting the success of tadalafil therapy in young men with ED. The study also reveals that nonresponders were older, had higher BMI, and reported lower baseline IIEF-EF scores than tadalafil responders. This information could be helpful for health care professionals in identifying which patients are more likely to benefit from daily tadalafil therapy and tailoring treatment plans accordingly. While the study provides valuable insights, it is important to note that it was limited to a relatively small sample size. Further research with larger sample sizes and diverse populations is needed to confirm and expand upon these findings.

In conclusion, this study found that nearly half of young ED patients prescribed daily 5 mg tadalafil experienced full EF recovery within 3 months of treatment. Younger patients were more likely to achieve EF recovery with this therapy. As a result, daily 5 mg tadalafil therapy could be a viable treatment option for young men experiencing ED. Health care professionals should consider age, BMI, and baseline IIEF-EF scores when prescribing tadalafil therapy to maximize its effectiveness and improve patients’ quality of life.