All patients reported the medication intake in their files with no dropouts but the needed
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Premature ejaculation (PE) is a male sexual disorder characterized by a brief intra-vaginal ejaculatory latency time (IELT) and lack of ability to properly control ejaculation which has detrimental personal effects [Citation1]. There is no global definition for PE. PE is defined according to the International Society for Sexual Medicine (ISSM) guidelines as ejaculation that always happens in fewer than 1 minute following vaginal penetrating from the initial sexual encounter (lifelong PE), or a decrease in IELT, less than 3 min (acquired PE) with inability to delay ejaculation on all or nearly all vaginal penetrations and negative personal consequences, such as distress, frustration, bother and/or avoidance of sexual intimacy [Citation2]. Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) define PE as a persistent or recurrent ejaculation that occurs within approximately 1 minute after vaginal penetration and before the individual wishes it. The problem must present for at least 6 months and present on almost all (approximately 75–100%) or on all occasions of sexual attempts with clinically significant distress and cannot be explained by a nonsexual mental disorder or as a result of severe relationship distress and is not attributable to the effects of a substance/medication or other medical condition [Citation3,Citation4].
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A recent comprehensive novel classification of PE was reported by Raveendran A. In this classification, the grading of the severity of reduction of IELT was reported as mild or grade 1 (IELT of 2 to 3 minutes), moderate or grade 2 (IELT of 1 to less than 2 minutes), severe or grade 3 (IELT less than 1 minute), and extreme or grade 4 (ejaculation occurring prior to vaginal penetration) [Citation5]. Premature ejaculation is a frequent male sexual dysfunction, although the real incidence is unclear, 24% to 30% of males may be affected [Citation6,Citation7]. Several drugs as tricyclic antidepressants (e.g. clomipramine) and tramadol could be used for treatment of PE.
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Selective serotonin-reuptake-inhibitors (SSRIs), like escitalopram, fluoxetine, serteralin, paroxetine and dapoxetine are the most common medications used for management of PE [Citation8–10]. As SSRI, dapoxetine was the first licenced drug with FDA approval used for on-demand management of PE. Dapoxetin acts by neglecting the effect for the different G protein coupled and ligand gated channels for all 5-hydroxytryptamin (5-HT) receptor subtypes, it inhibits the 5-HT transporter and activate the 5-HT 2C receptor, an action which diminishes the operation of 5-HT 1A receptor, thus reattaining equilibrium between the actions of 5-HT 1A and 5-HT 2C receptors and this leads to increased 5-HT levels in the synaptic clefts which results in delayed ejaculation [Citation11]. Nitric oxide (NO) activates guanylate cyclase which increases the intracellular cGMP in the corpus cavernosum causing smooth muscle relaxation. PDE-5 inhibitors act through increasing nitric oxide which causes relaxation of the smooth muscles of corpus cavernosum and the vas deferens and seminal-vesicles, also they reduce anxiety from sexual performance which is commonly associated with PE [Citation12]. time for drug intake (two hours before sexual intercourse) was not regularly respected by the patients.
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No statistically substantial variations were found before treatment among the three groups as regard age, BMI, smoking, fasting blood sugar, FSH, LH, testosterone, E2, and prolactin levels ().
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The Cohen’s d effect size was approximately estimated to be 0.4. Therefore, with an alpha of 0.05 using the ANOVA test, the enrollment of a total of 84 patients in each group will provide 90% power. The sample size was increased to compensate for any attrition bias. We evaluated the eligibility of 385 patients for this research. After exclusions, 92 patients were included in group A and received tadalafil (5 mg) for 12-weeks period, 91 patients were included in Group B and received dapoxetine (30 mg) for 12-weeks period, and 89 patients were included in Group C and received tadalafil (5 mg) and dapoxetine (30 mg) together for 12-weeks period (). The mean of IELT in all the studied patients was 39.3 ± 10.5 seconds, median was 37 (31.25–46) seconds with minimum IELT of 25 seconds and maximum IELT of 65 seconds.
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The Kim and Paick scale, which ranges from 0 to 5, while 0 denoting severe dissatisfaction and 5 denoting extreme pleasure, was used to evaluate sexual satisfaction in all participants prior to and following therapy [Citation15]. Patients were also advised to note any side effects following medication delivery in their follow-up sheets both during medication intake and at the end of treatment. Patients were followed up every month for three months. The local Ethics Committee approved the best generic cialis the study. The ethical approval code is: SVU-MED-URO 016-1-21-4-183.
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The study was performed according to the ethical declaration of Helsinki. Every participant signed a written statement of permission. The Statistical Program for Social Science (SPSS) Version 24.0 was used for the statistical analysis. The mean and standard deviation (M ± SD) were used to represent quantitative data. The frequencies and percentages [n(%)] were used to convey qualitative data.
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Nonparametric data were compared using a Chi-squared (x2) test. When contrasting more than two means, a one-way analysis of variance (ANOVA) was utilized if the data was normally distributed and Kruskal Wallis (KW) test was utilized if the data was not normally distributed. P values were considered statistically significant at P < 0.05. To determine the sample size using the G*Power Version 3.1.9.4, we used the IELT to detect a 60-second (1-minute) variation among groups A, B, and C (based on the previous studies). A standard deviation of 150 seconds (2.5 minutes) was used for the sample size calculation. When comparing IELT before treatment and at the end of treatment (12 weeks posttreatment), there were highly statistically substantial variations in group A (39.4 ± 10 sec.
| Contraindication | Explanation |
|---|---|
| Use with Nitrates | Can cause severe hypotension |
| Severe Liver Disease | Reduced drug metabolism, increased risk |
| Recent Stroke or Heart Attack | Risk of cardiovascular complications |
| Known Hypersensitivity | Allergic reactions possible |
When comparing group C with either group A and group B, no significant variation was found (P = 0.580) for the mean
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According to several researches, using SSRIs and PDE-5 inhibitors together enhances sexual pleasure and boosts IELT when compared with taking SSRIs alone. PDE-5 may suppress the central sympathetic tone, which causes better erection and increased the time interval for ejaculation [Citation13]. This study aimed to compare the pharmacological effect assessed by IELT in men suffering from PE by using either dapoxetine alone, tadalafil alone, or their combination as a primary outcome and to evaluate the possible side effects of drug therapy as a secondary outcome. This was a prospective, randomized work of patients who attended our andrology clinic with PE from May 2021 to September 2022. Patients were randomly allocated into three groups (using a block randomization strategy in Stata, version 13.1, Stata Corp, for Microsoft windows).
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Participants in group (A) received on- demand tadalafil 5 mg two hours before intercourse; Participants in group (B) received on- demand dapoxetin 30 mg two hours before intercourse; and Participants in group (C) received an on-demand combination of both tadalafil 5 mg and dapoxetin 30 mg two hours before intercourse. Each participant was instructed to engage in sexual activity 2–3 times per week. If an individual met the International Society for Sexual Medicine’s requirements which describes PE as ejaculation that always happens within a minute, following vaginal penetration during the initial sexual encounter (lifetime PE), or a substantial decline in IELT, often within less than 3 minutes (acquired PE), with detrimental personal effects, including anxiety, annoyance, and/or avoiding of sexual intimacy, PE was assumed to be present. All patients were cialis tadalafil 20mg evaluated by filling a detailed documented medical history including the International Index of Erectile Function (IIEF) 5- items questionnaires to exclude those with erectile-dysfunction [Citation14]. All patients were instructed to report in a written diary the correct medication intake in their files.
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Inclusion criteria were heterosexually active men aged more than 20 years with PE (patients with type 1 or lifelong PE were not discriminated from those with acquired type) with IIEF > 22 and at least a three-months period in a stable sexual relationship preceding the research. Exclusion criteria were individuals with diabetes mellitus, chronic prostatitis, erectile dysfunction (IIEF <22), neurological disorders, penile implants or deformities, homosexual men and those who were taking medications for neurological or psychiatric disorders and non-compliant patients. Each patient received a comprehensive pretreatment evaluation that include medical history, clinical assessment, fasting blood glucose level, and hormonal profile (blood glucose and testosterone were measured in the early morning while the patient was fasting). Each patient was assessed with measurements of IELT using a stopwatch (held by the partner) at baseline and after treatment. A full explanation about the measurement of the ILET (beginning with intromission and ending with ejaculation) was done. pretreatment IELT measurements (group A: 39.4 ± 10 sec; group B: 40.8 ± 11.2 sec; and group C: 37.9 ± 10.9 sec; ). When comparing group C with either group A and group B, highly statistically substantial variations were found in the mean IELT at 4, 8, and 12 months posttreatment in
| Side Effect | Frequency | Severity | Notes |
|---|---|---|---|
| Nausea | Common | Mild to Moderate | Usually resolves with time |
| Dizziness | Less common | Mild | Avoid operating machinery |
| Headache | Common | Mild | Often occurs in initial doses |
| Insomnia | Less common | Mild | May affect sleep patterns |
favor of group C (P = < 0.001), also highly statistically substantial variations were found in the mean Δ IELT in favor of group C (P < 0.001; ).
| Precaution | Rationale | Advice |
|---|---|---|
| Avoid alcohol while taking | Can enhance side effects | Limit intake during treatment |
| Use in dose as prescribed | To reduce side effect risk | Do not exceed 60 mg dose |
| Monitor for serotonin syndrome | Especially if combined with other medications | Seek immediate medical help if symptoms occur |
| Patients with cardiac issues | Risk of adverse effects | Consult cardiologist before use |
Post hoc tests at 4, 8, and 12 weeks posttreatment revealed no statistically substantial variations in the mean IELT (P
- Cialis Plus Priligy treatment success depends on adherence to recommended dosage and schedules.
- Monitor blood pressure regularly, as the medication can cause hypotension in sensitive individuals.
- Inform your doctor if you develop symptoms like prolonged erection lasting more than 4 hours.
- Cialis’s mechanism differs from other ED drugs by longer half-life allowing more spontaneity.
- Dapoxetine selectively inhibits serotonin reuptake, improving control over ejaculation reflex.
- Avoid use with other PDE-5 inhibitors or SSRIs without medical guidance.
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- The combination should be avoided in patients with certain inherited eye conditions.
- Cialis Plus Priligy does not increase sexual desire but improves performance and control.
- Discuss any existing psychiatric or neurological disorders before starting treatment.
= 0.346, P = 0.508, P = 0.442 respectively) or Δ IELT (P = 0.340) among group A and group B.
- Cialis Plus Priligy has been studied for safety in men with mild to moderate erectile dysfunction.
- Its dual action can reduce the need for multiple separate medications improving compliance.
- Tadalafil’s long window allows for less scheduled sexual activity compared to shorter acting drugs.
- Dapoxetine’s effect on ejaculation timing enhances sexual satisfaction for both partners.
- Some patients report improvement in mood and confidence during sexual activity with this drug.
- Regular medical assessment ensures you maintain safe and effective treatment.
- Avoid use if you have uncontrolled hypertension or recent stroke history.
- Cialis Plus Priligy should be avoided in combination with potent CYP3A4 inhibitors.
- The drug does not protect against HIV or other sexually transmitted infections.
- Psychological support remains important alongside pharmacological treatment.
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