Daily Tadalafil: Benefits Beyond Erectile Dysfunction

(21) compared patients with vasculogenic ED and non-vasculogenic ED, both treated with tadalafil.

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The mean amplitude value in penile sensorial EMG sublingual tadalafil was 4.47±1.32 before treatment, whereas it increased to 5.07±1.60 after treatment (p<0.015). Additionally, the mean latency value was 2.14±0.42 before treatment, whereas it increased to 2.32±0.38after treatment (p<0.001). The latency and amplitude parameters in the penile sensorial EMG are used to calculate NCV. The increase in these values after treatment was interpreted as an improvement in penile sensation. As a result, it has been shown that the improvement in IIEF-5 provides an improvement in penile sensation (Figure 1).

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Currently, PDE-5 inhibitors are used as first-line therapy in patients presenting with ED. Our literature search did not find any studies reporting normal values of penile sensation during a normal erection. In our study, we performed sensorial measurements in patients with ED. Penile sensorial EMG can provide valuable additional information in the differential diagnosis of ED, particularly allowing the identification of different neurogenic lesion sites (16). (17) injected intracavernosal papaverine in 15 patients with ED and compared the results of penile EMG and biopsy examinations. They have demonstrated the therapeutic effects of tadalafil on non-vasculogenic ED. (22) showed that long-term tadalafil therapy in diabetic rats partially reduced penile oxidative stress lesions through a local antioxidative stress pathway.

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Accordingly, they reported that the initiation of long-term once-daily tadalafil therapy immediately after the diagnosis of DM may partially prevent the development of diabetic ED in rats.

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We included patients with a history of at least 6 months of ED who did not receive any treatment, patients with normal serum levels of testosterone and luteinizing hormones, and patients who were recommended to use tadalafil for 12 weeks. Patients with a history of hypogonadism, cryptorchidism, varicocele, peripheral neuropathy, uncontrolled diabetes mellitus (hemoglobin a1c >7%), and past and current illicit drug abuse were excluded from the study. The demographic and clinical characteristics of all patients were recorded. All patients participating in the study completed the International Index of Erectile Function (IIEF-5) form and underwent penile EMG examination before and after treatment. Patients were divided into two groups as over 50 years old and under 50 years old.

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A comparative evaluation was made on the effect of age on the outcomes of treatment and penile sensorial EMG. Electrophysiological studies were planned to be performed between 09:00 and 12:00, at a room temperature of 23 to 25 °C, in a quiet room with dim light, and with the relaxed and awake patient in the supine position. A two-channel electroneuromyography device (Nihon-Kohden-Neuropack, model MEB-2200) was used for recording. Penile sensorial tadalafil weekend pill EMG was examined using Clawson’s method. The penis was placed in the concavity of a specially designed Orthoplast penile traction device and stretched to reach its maximum length by pulling from the tip of the glans. In our study, we examined patients who received 12 weeks of tadalafil therapy regardless of the

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cause of ED and performed IIEF scoring and penile sensorial EMG examinations before and after treatment.

Parameter	Value	Description
Half-life	17.5 hours	Time for plasma concentration to reduce by half
Time to Peak	2 hours	When maximum plasma concentration occurs
Absorption Rate	Rapid	Absorbed quickly after oral intake
Metabolism	Liver (CYP3A4 enzyme)	Mainly metabolized in the liver

A significant correlation was observed between the IIEF score and penile sensorial EMG findings.

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A statistically significant improvement was observed in IIEF, NCV, and latency values in both age groups.

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This improvement was consistent with the literature. The mean nerve conduction velocities (NCV) in EMG was 35.5 m/sec (33.3-41.2) before treatment, and 38.05 m/sec (34.5-43.6) after treatment (p<0.001). The increase in NCV is the most important finding of penile sensorial EMG showing an increase in penile sensation. Thus, the increase in NCV has been interpreted as an improvement in penile sensation. The changes in latency and amplitude values used in the calculation of NCV are given in Table 2.

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The delta equation (Δ = the amount of change) was created for the IIEF-5 score and penile sensorial EMG findings as post-treatment value minus pre-treatment value. Factors that may be related to this change were evaluated. There was a significant correlation between age and IIEF-5 score and penile sensorial EMG findings. There was a significant correlation between the IIEF-5 score and NCV (r=0.663, p<0.001) and Amplitude (r=0.659, p<0.001). As improvement in IIEF-5 increases, so does improvement in NCV and Amplitude (Table 3). (p<0.001, p<0.001, p=0.010 for ≤50 years of age; and p<0.001, p=0.012, p=0.030 for >50 years of age, respectively).

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A Cunningham incontinence clamp was placed on the glans, and the penis was maintained in tension by holding from the glans. An electroencephalography paste was used for the placement of active and reference steel electrodes. The active recording electrode was placed as proximal as possible to the root of the penis. The reference electrode was placed 4 cm above the active electrode. The proximal part of the dorsal penile shaft was stimulated orthodromically with an active electrode and the dorsal glans with a reference electrode (15).

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Categorical data were presented as number and percentages. Continuous data were evaluated by the Kolmogorov-Smirnov test to verify the normality of the distribution of variables. Normally distributed data were presented as mean + standard deviation, while non-normally distributed data were presented as median and IQR (25-75th). An independent simple t-test was used to compare two independent normally distributed data, while the Mann-Whitney U test was used for the comparison of non-normally distributed data. A paired sample t-test was used to compare two independent normally distributed data, while the Wilcoxon test was used for the comparison of non-normally distributed data. There was a comparable improvement in the IIEF score in both age groups (p=0.314), whereas there was

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a statistically higher improvement in NCV and latency values in the group aged ≤50 years (p<0.001, p=0.001, respectively).

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They demonstrated low -amplitude values in 5 patients with diabetes mellitus. Penile sensorial EMG is a less-invasive, valuable method for patients with ED, whereas penile biopsy examination did not reveal any specific results. Kayigil and Ergen (18) reported lower amplitude values in the EMG of the corpus cavernosum (CC-EMG) in 45%-65% of patients with ED. (19) included 24 patients, 16 with normal findings on neurological examination, and 8 with diabetic neuropathy. They investigated the sensory conduction velocity in the dorsal penile nerve at rest and after injection of prostaglandin E1.

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They tadalafil sale reported that the mean NCV values increased from 32.3+/-6.7 m/s to 47.4+/− 8.2 m/s after the injection of prostaglandin E1. They also reported an increase in NCV in patients with improvement in ED. We also showed an increase in NCV after 12 weeks of daily treatment with tadalafil compared with pre-treatment values. The mean NCV in EMG was 35.5 m/s (33.3-41.2) before treatment, and 38.05 m/s (34.5-43.6) after treatment (p<0.001). (20) showed a reduction in proinflammatory cytokines in rats with a 12-week high-dose tadalafil therapy. A significant correlation was observed between the IIEF score and EMG findings.

Condition	Approval Status	Notes
Erectile Dysfunction	Approved	Daily use approved by FDA
Benign Prostatic Hyperplasia (BPH)	Approved	Approved for BPH symptoms
Pulmonary Arterial Hypertension	Approved	In specific formulations
Diabetes-related ED	Experimental	Not officially approved for this use

There was a significant correlation between IIEF and NCV (r=0.663, p<0.001) and Amplitude (r=0.659, p<0.001).

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Recently, inhibitors of the phosphodiesterase-5 (PDE-5) enzyme have been the most widely used treatment for ED. Tadalafil is an effective and well-tolerated treatment for ED (13). Tadalafil at a dose of 5 mg once daily significantly improves ejaculation and orgasm, sexual intercourse and overall satisfaction, and erectile function (14). In this study, we showed the change in penile sensation in men after treatment with ED. Additionally, this topic has not yet been studied in the literature as far as we know.

Statistical analysis

The inclusion of patients using daily therapy for ED regularly was aimed at a clear assessment of outcomes. This research has a prospective and controlled study design. A signed consent form was obtained from all patients who volunteered to participate in the study. Ethics Committee approval for this study was obtained from the Ethics Committee of Health Sciences University, Antalya Training and Research Hospital (2020-352), and all steps were planned and conducted following the Declaration of Helsinki and its later amendments. Patients who started treatment for ED in the andrology outpatient clinic were referred to the study by the secretariat. Our study has some limitations, including the absence of data on normal values in penile sensorial EMG in individuals with normal erectile function.

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Spearman’s Correlation analysis was used to analyze the parameters related to changes in IIEF scores. A p-value of <0.05 was considered statistically significant. Analysis of the dataset was carried out using the IBM Statistical Package for Social Sciences version 23.0 (IBM SPSS Corp.; Armonk, NY, USA). One patient discontinued the treatment with the complaint of myalgia, and the study was continued with 28 patients since another patient did not come to the follow-up visit. The mean age of the patients was 53±9 years.

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The mean duration of ED was 6.8 months. There were 8 (29%) patients with diabetes and 7 (25%) patients with hypertension. The demographic characteristics and comorbidities of the patients are given in Table 1. We showed statistically significant changes in pre-treatment and post-treatment IIEF-5 scores and penile sensorial EMG findings. Pre-treatment IIEF-5 scores of 13±3 were measured as 19±3 after treatment with tadalafil at a daily dose for 12 weeks (p<0.001). The literature search did not show any studies reporting normal values on penile sensorial EMG in a healthy male.

• Tadalafil works by increasing blood flow to the penis.
• It is also used to treat pulmonary hypertension.
• Use daily tadalafil as part of a prescribed treatment plan.
• Possible interactions include nitrates and blood pressure medicines.
• Monitoring for side effects is important during therapy.

Additionally, another limitation is the absence of any data on the effects of socioeconomic status on penile sensation in our study.

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• It may take several days to see the full benefits.
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