madman
Super Moderator
ABSTRACT
Objective: 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.
Patients and Methods: A prospective, single-blind, randomized 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) was treated with daily 5-mg tadalafil for 3 months, and Group II (80 patients) was 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.
Results: The mean (SD) IELT and IIEF-5 scores 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]. 2 years after cessation of tadalafil, there was a statistically significant improvement in the IELT and IIEF-5 from baseline to endpoint.
Conclusion: 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.
Introduction
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 favor 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 intravaginal ELT (IELT) is used to evaluate ED and PE, respectively. The IELT has higher sensitivity and specificity for the evaluation of PE [9].
There are many modalities for PE treatment, the most commonly used are behavioral and pharmacological therapy, but behavioral 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 anesthesia 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 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.
In our present study, most of the side effects were mild and tolerable. No patient discontinued the medications due to these side effects in the form of headache, myalgia, and lower back pain, which agrees with Karabakan et al. [21] who reported mild symptoms that disappeared over time, including headache, muscle, low back pain, and flushing
To our knowledge, the present study is the first to assess the long-term effect of daily 5-mg tadalafil on ED and PE after 2 years of medication cessation and revealed the persistence of significant long-term improvement that proves the presence of a continuous circle and co-existence of ED and PE.
The limitation of our study is that it is a single-blind study with small sample size. A double-blinded randomized study based on subjective and objective evaluation tools for sexual functional outcomes and a larger population is recommended.
We conclude that a daily 5-mg tadalafil oral tablet is an effective, tolerable, and safe treatment option for patients with ED and PE. In addition, we noticed significant long-term improvement after the cessation of tadalafil.
Main points
(1) PE co-exists with ED in 30% of patients.
(2) The IIEF-5 and IELT can be used to evaluate ED and PE, respectively.
(3) IELT has higher sensitivity and specificity for the evaluation of PE.
(4) Daily 5-mg tadalafil for 3 months is an effective, tolerable, and safe treatment for patients with ED and PE, which is also still effective 2 years after cessation. So we advise, from the results of our present study, implementing daily 5-mg tadalafil for 3 months in patients with both ED and PE.
Objective: 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.
Patients and Methods: A prospective, single-blind, randomized 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) was treated with daily 5-mg tadalafil for 3 months, and Group II (80 patients) was 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.
Results: The mean (SD) IELT and IIEF-5 scores 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]. 2 years after cessation of tadalafil, there was a statistically significant improvement in the IELT and IIEF-5 from baseline to endpoint.
Conclusion: 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.
Introduction
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 favor 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 intravaginal ELT (IELT) is used to evaluate ED and PE, respectively. The IELT has higher sensitivity and specificity for the evaluation of PE [9].
There are many modalities for PE treatment, the most commonly used are behavioral and pharmacological therapy, but behavioral 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 anesthesia 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 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.
In our present study, most of the side effects were mild and tolerable. No patient discontinued the medications due to these side effects in the form of headache, myalgia, and lower back pain, which agrees with Karabakan et al. [21] who reported mild symptoms that disappeared over time, including headache, muscle, low back pain, and flushing
To our knowledge, the present study is the first to assess the long-term effect of daily 5-mg tadalafil on ED and PE after 2 years of medication cessation and revealed the persistence of significant long-term improvement that proves the presence of a continuous circle and co-existence of ED and PE.
The limitation of our study is that it is a single-blind study with small sample size. A double-blinded randomized study based on subjective and objective evaluation tools for sexual functional outcomes and a larger population is recommended.
We conclude that a daily 5-mg tadalafil oral tablet is an effective, tolerable, and safe treatment option for patients with ED and PE. In addition, we noticed significant long-term improvement after the cessation of tadalafil.
Main points
(1) PE co-exists with ED in 30% of patients.
(2) The IIEF-5 and IELT can be used to evaluate ED and PE, respectively.
(3) IELT has higher sensitivity and specificity for the evaluation of PE.
(4) Daily 5-mg tadalafil for 3 months is an effective, tolerable, and safe treatment for patients with ED and PE, which is also still effective 2 years after cessation. So we advise, from the results of our present study, implementing daily 5-mg tadalafil for 3 months in patients with both ED and PE.
