Patients who were lost to follow-up
A statistical significance at P < 0.05 was required for the two co-primary endpoints (IIEF-5, IELF) to reject the null hypothesis, and a sample size of 160 patients (80 placebo and 80 tadalafil) was calculated to give 90% power to detect a significant treatment effect. Patients were subdivided into two equal groups and randomised using the secure envelope method. Group I included 80 patients treated with a daily 5-mg tadalafil oral tablet for 3 months, and Group II included 80 patients treated with a placebo for the same period. The tadalafil group were followed up for 2 years after cessation of tadalafil, but five patients were lost during follow-up, and so 75 patients were assessed at the end of 2 years. Full medical and sexual history was taken with the history of current medications, a complete physical and genital examination was performed, and all patients were evaluated using the IIEF-5 to evaluate ED and IELT for PE [16] before and after treatment and at the end of the 2-year follow up.
The IIEF is a multidimensional validated questionnaire including 15 questions in the five domains of sexual function (erectile and orgasmic functions, sexual desire, satisfaction with intercourse, and overall sexual satisfaction). More recently, to simplify the IIEF, an abridged five-items version the IIEF-5 has been used as a diagnostic tool for ED and evaluation of treatment. It consists of only five questions, and each IIEF-5 item is scored on a 5-point ordinal scale where lower values represent an impaired sexual function. According to this scale, ED is classified into three grades based on IIEF-5 scores: severe ED (score: 1–7), moderate ED (8–11), and mild ED (12–21) [17]. The IELT was defined as the time from intravaginal intromission to intravaginal ejaculation. were considered as a failure to treat.
| Medication Type | Specific Drugs | Interaction Effect |
|---|---|---|
| Nitrates | Nitroglycerin | Severe hypotension |
| Alpha-blockers | Doxazosin, Tamsulosin | Increase risk of hypotension |
| CYP3A4 inhibitors | Ketoconazole, Ritonavir | Increased plasma levels |
| Antifungals | Itraconazole, Clarithromycin | Possible increased side effects |
| Other PDE5 inhibitors | Sildenafil, Vardenafil | Increased risk of adverse effects |
The level of significance was
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Generic | 60mg | 90 + 6 Pills | 196.67€ 187.30€ | |
| Cialis Generic | 5mg | 270 + 10 Pills | 205.81€ 196.01€ | |
| Cialis Generic | 40mg | 180 + 10 Pills | 277.29€ 264.09€ | |
| Cialis Black | 80mg | 60 + 4 Pills | 150.98€ 143.79€ | |
| Cialis Professional | 20mg | 120 + 4 Pills | 291.68€ 277.79€ | |
| Cialis Black | 80mg | 180 + 10 Pills | 356.64€ 339.66€ | |
| Cialis Generic | 2.5mg | 60 + 4 Pills | 83.43€ 79.46€ | |
| Cialis Generic | 10mg | 120 + 6 Pills | 178.49€ 169.99€ | |
| Cialis Generic | 60mg | 10 Pills | 41.22€ 39.26€ | |
| Cialis Generic | 40mg | 120 + 8 Pills | 206.98€ 197.12€ |
accepted for P < 0.05.
Both groups were comparable for
At Georgia Urology, your options run the gamut – from pharmaceutical therapies and minimally invasive procedures that take just a few minutes to more extensive surgical interventions when appropriate. We’ve also recently opened a state-of-the-art IR center specializing in Prostatic Artery Embolization (PAE), one of the most promising non-surgical treatments for an enlarged prostate. The best way to make informed decisions is by consulting with a men’s health urologist who can tailor a plan to your specific needs. Modern urology has never been as advanced as it is today, with new procedures and options for virtually every man. Contact us and schedule an appointment to learn more.
To evaluate the safety and effectiveness of daily 5-mg tadalafil treatment for men who have erectile dysfunction (ED) and premature ejaculation (PE), and to assess the long-term follow-up for ED and PE improvement persistence years after the cessation of medication. A prospective, single-blind, randomised study included 160 patients with ED and PE. All were evaluated using the International Index of Erectile Function (IIEF-5) questionnaire to evaluate ED and intravaginal ejaculatory latency time (IELT) for PE. Patients were subdivided into two equal groups. Group I (80 patients) treated with daily 5-mg tadalafil for 3 months, and Group II (80 patients) treated with a placebo for the same period.
After 3 months of treatment and 2 years later after cessation of tadalafil, all patients were assessed for ED and PE. The mean (SD) IELT and IIEF-5 score pre-treatment were 37 (11.24) s and 13.2 (4.2) for Group I, while in Group II they were 35.98 (10.8) s and 13.12 (4.11), respectively. After 3 months of treatment, the mean (SD) IELT in Group I showed a highly significant improvement from 37 (11.24) s to 120.5 (47.37) s (P < 0.001) but Group II showed no significant improvement from baseline to [39.43 (13.6) s; P > 0.05]. For the IIEF-5 score, there was a highly significant improvement from baseline to 20.45 (4.5) in Group I (P < 0.001), while there was no significant difference in Group II from baseline to [15 (4.84); P > 0.05]. At 2 years after cessation of tadalafil, there was statistically significant improvement in the IELT and IIEF-5 from baseline to endpoint . age, weight, and height (Table 1).
| Parameter | Value | Description |
|---|---|---|
| Absorption Time | About 2 hours | Time to reach peak plasma levels |
| Half-life | 17.5 hours | Duration of drug presence in blood |
| Bioavailability | 40% | Percentage absorbed into circulation |
| Metabolism | Liver (CYP3A4 enzyme) | Primary pathway |
| Excretion | Feces and urine | Elimination routes |
At the end of 3 months, the
mean (SD) IELT in Group I showed
a highly significant improvement from 37 (11.24)
There are many modalities for PE treatment, the most commonly used are behavioural and pharmacological therapy, but behavioural therapy is inefficient for many couples. Although many drugs are used for PE, serotonin reuptake inhibitors are the most common drugs used in PE. Other medications like topical anaesthesia or opioid agonists, like tramadol, are less commonly used [10]. Tadalafil with once-daily (OAD) and on-demand [pro re nata (PRN)] dose regimens is sufficient for treating ED. Other studies reported that the tadalafil OAD dose regimen is better, and more sexual satisfaction occurred than PRN [11,12].
Tadalafil, which is commonly used in the treatment of ED, has been recently investigated in some studies for treating PE, and most of these studies reported a significant improvement [13–15]. There were no data in the literature about long-term follow-up results of tadalafil on the improvement of PE. The present study evaluated the efficacy of daily 5-mg tadalafil treatment vs placebo for 3 months on the erectile function (assessed using the IIEF-5) and ejaculation time (IELT) in patients with ED and PE. In addition, we investigated whether there was a significant improvement in the IIEF-5 and IELT after the stoppage of tadalafil for a long time. A prospective, single-blind, randomised study comparing the safety and efficacy of 5-mg tadalafil continuous daily dosing for 3 months compared with placebo for ED with PE and assessment of persistence of improvement after 2 years from the cessation of tadalafil.
This study was conducted on 160 patients attending the urology outpatient clinic, Benha University Hospital, and Al-Azhar University Hospital from April 2018 to April 2019, including men aged 18–65 years who had ED and lifelong PE for the last 6 months of a continuous marriage relationship. We excluded from our study patients with a neurogenic disorder, parkinsonism, diabetes mellitus, active Urinary tract infection (UTI), chronic prostatitis, chronic renal failure, Peyronie’s disease, and endocrine disorders, including low testosterone, hyperprolactinaemia, and thyroid dysfunction, patients taking medications for PE and drugs affecting erectile function. Written informed consent was obtained from all patients enrolled in this study, which the local ethics committee approved. The sample size was calculated using the EPI info 2000 statistical package (Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA). The null hypothesis of the study was that tadalafil has no treatment effect relative to placebo. to 120.5 (47.37) s (P < 0.001).
Oral daily 5-mg tadalafil was effective, tolerable, and safe treatment for patients with ED and PE. Long-term follow-up at 2 years confirmed the persistence of a significant improvement for both ED and PE. Abbreviations: ED: erectile dysfunction; IIEF-5: five-item version of the International Index of Erectile Function questionnaire; IELT: intravaginal ejaculatory latency time; OAD: once-daily; PDE5i: phosphodiesterase-5 inhibitors; PE: premature ejaculation; PRN: pro re nata Erectile dysfunction (ED) and premature ejaculation (PE) are the most common sexual dysfunctions with a prevalence of ~30% and ~20%, respectively [1,2]. ED is a failure to accomplish and maintain an adequate erection to reach satisfaction with sexual intercourse for the last 6 months, while PE is defined as an early ejaculation within ~1 min with minimal sexual excitation just after intravaginal penetration with involuntary control that has occurred for ≥6 months in all or almost all sexual activities, leading to anxiety and depression [3]. Sexual dysfunction includes ejaculatory and orgasmic disorders, ejaculatory disorders include PE and retarded ejaculation (RE), but orgasmic disorders include anorgasmia and hypo-orgasmia.
PE is classified into primary or lifelong and secondary or acquired [3]. Organic factors are the commonest predictors for acquired PE, such as prostatitis [4] and endocrine disorders [5,6]. Still, routine hormonal testing should only be directed to the patient’s complaints and risk factors with specific findings from history or physical examination [7]. Every man with PE should be adequately screened for ED, and where present, this should be addressed first. Men with ED can have performance anxiety, which may also favour PE.
Accordingly, treating men with ED with ED medications improves erections and ejaculatory latency times (ELTs) [7,8]. PE co-exists with ED in ~30% of patients, mainly secondary PE. However, the specific phenotype of ED-PE men has never been systematically investigated. The five-item version of the International Index of Erectile Function (IIEF-5) questionnaire and pharmacy cialis uk intravaginal ELT (IELT) is used to evaluate ED and PE, respectively. The IELT has higher sensitivity and specificity for the evaluation of PE [9].