These findings indicate that Citalopram not only prolonged latency time objectively but also yielded the most favorable patient-reported outcomes, suggesting a greater overall benefit in the psychological and relational aspects of premature ejaculation management.
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Group B: Received Silodosin 4 mg, administered orally once daily. Group C: Received Dapoxetine hydrochloride 30 mg, taken 2 h before intercourse, on-demand, minimum of 8 times/month for 3 months. Group D: Received Dapoxetine hydrochloride 30 mg, administered daily. Comprehensive medical history, including comorbidities (e.g., diabetes, hypertension), medication review for drug interactions, erectile function and prostatitis. Physical examination focused on genitourinary abnormalities (e.g., prostatitis, hypospadias).
Ethics approval and consent to participate
Lab tests: including FSH, LH, free testosterone, cholesterol, and triglycerides. The assessors of the outcomes were blinded during the study procedures. Adherence was assessed at each visit by pill count and patient diaries. We assessed clinical meaningfulness using distribution-based MCID thresholds because there is currently no published literature which identifies a clinically significant threshold response to IVELT and PEPQ. Following established methodology, we prespecified 0.5 SD of baseline IVELT and PEPQ as the primary MCID. Pairwise analysis post treatment according to PEPQ (Table 4) showed that Citalopram was significantly more effective than Silodosin in all domains (P < 0.001), and superior to both Dapoxetine doses in most comparisons, including interpersonal difficulty (P < 0.01).
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Dapoxetine 30 mg (daily) outperformed 30 mg (on demand) in select categories (P = 0.01 for interpersonal difficulty), though not all comparisons reached statistical significance.
| User Profile | Number of Users | Reported Benefits | Common Complaints | Satisfaction Level |
|---|---|---|---|---|
| Young Men (20-30s) | 150 | Improved control during intimacy | Mild side effects, mood swings | 4.2/5 |
| Middle-aged Men (40-50s) | 200 | Less anxiety, increased confidence | Headache, nausea | 4.0/5 |
| Novice Users | 100 | Ease of purchase, quick effect | Dizziness, dry mouth | 3.8/5 |
All treatment arms exceeded the 0.5 SD MCID for IELT and PEPQ.
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The study protocol was approved by the Institutional Review Board (IRB) of the Faculty of Medicine, Beni-Suef University (Approval No. : FMBSUREC/07052024/Ahmed), and all participants provided written informed consent prior to enrollment. A priori power analysis was conducted using G*Power 3.1 to determine the appropriate sample size for detecting differences in IELT among the four treatment groups. Based on an ANOVA model accounting for four treatment groups and four covariates (age, baseline IELT, comorbidities, and medication adherence), we calculated the required sample size using a medium effect size (f = 0.25), α = 0.05, and 95% power. The numerator degrees of freedom (df = 7) comprised 3 df for between-group comparisons (4 groups − 1) plus 4 df for the covariates.
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With 400 total participants (100 per group), the denominator df was 392, yielding a noncentrality parameter (λ) of 25.00 and achieving the target power of 0.950. This approach ensured adequate power to detect clinically meaningful differences while controlling relevant covariates. The total sample size in the ANOVA/ANCOVA framework was determined using the noncentral F distribution according to the following relationship: The achieved power is then calculated as: Using f = 0.25, α = 0.05, and 95% power, with four treatment groups and four covariates, the required sample size was confirmed as 400 participants (100 per group). Diagnosis of PE according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-V-TR) [12]. ◦ Persistent or recurrent ejaculation within approximately 1 minute of vaginal penetration (confirmed by stopwatch-measured IELT ≤60 seconds at baseline) ◦ Inability to delay ejaculation during all or nearly all vaginal penetrations ◦ Negative personal consequences (distress, frustration, avoidance of sexual intimacy) Premature Ejaculation Diagnostic Tool (PEDT) score ≥11. Responder rates were correspondingly high and exceeding the MCID threshold largely (Table 5).
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Intravaginal Ejaculatory Latency tadalafil dapoxetine Time (IELT): Measured by the partner using a wristwatch (Casio®, Tokyo, Japan), defined as the interval between vaginal penetration and ejaculation. IELT was recorded pre- and post-intervention (after 3 months). Premature Ejaculation Profile Questionnaire (PEPQ) [13]: Evaluated perceived ejaculatory control, sexual satisfaction, personal distress, and interpersonal difficulty. Each domain was assessed via a single-item, 5-point Likert scale (0–4), with higher scores indicating improved functioning. Side effects: Adverse effects were evaluated in terms of occurrence of nausea, diarrhea, vomiting, headaches, decreased semen volume, retrograde ejaculation, anejaculation, constipation, dizziness, sleep disturbance, and dry mouth.
Therapeutic Categories
Statistical analysis was performed using SPSS version 26.0 (IBM Corp., Armonk, NY, USA). Continuous variables were expressed as mean ± SD; categorical variables as number and percentage. Between-group comparisons were analyzed using ANOVA with post-hoc Tukey tests. Within-group pre/post comparisons were analyzed using paired t-tests. Categorical variables were compared using χ² or Fisher’s exact test. Figure 2 shows that there was no statistically significant difference among studied groups regarding nausea, diarrhea, vomiting and headache, while there was statistically significant increase of incidence in Group B (Silodosin 4 mg) than other groups regarding decrease semen volume, retrograde ejaculation and anejaculation and statistically significant increase in Group D (Dapoxtine 30 mg (daily)) than other groups regarding constipation, dizziness, sleep disturbance and dry mouth.
Dapoxetine Efficacy
Significance was set at p < 0.05. A total of 400 participants were included. Figure 1 shows the CONSORT flow diagram of the study procedures (Table 1), show Baseline characteristics were comparable across the four groups, with no statistically significant differences in age, duration of the disorder, comorbidities (diabetes mellitus, hypertension, cardiac or hepatic/renal disease), or laboratory data including FSH, LH, free testosterone, cholesterol, and triglycerides. Age ranged from 33.91 ± 8.84 years to 36.21 ± 8.98 years. Comorbid conditions were distributed without significant group differences. This study aimed to evaluate the effects of citalopram, dapoxetine, and silodosin in the treatment of premature ejaculation (PE), with a focus on changes in intravaginal ejaculatory latency time (IELT) and the psychological aspects of sexual function, including perceived control, satisfaction, personal distress, and interpersonal difficulty.
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Baseline characteristics were comparable across all groups, with no statistically significant differences observed in age, duration of PE, comorbid conditions (diabetes mellitus, hypertension, cardiac disease, hepatic/renal disease), or laboratory parameters (FSH, LH, free testosterone, cholesterol, and triglycerides). These findings suggest that the observed changes in treatment outcomes were independent of these baseline characteristics.
Safety and tolerability
In (Table 2) All treatment groups demonstrated a significant increase in IELT following 3 months of therapy. The greatest improvement was observed in the Citalopram group, where IELT increased from 110.4 ± 31.5 s to 391.2 ± 45.9 s. Median percent change in IELT was highest in the Citalopram group at + 260% (IQR: 197.5–330.5), followed by Dapoxetine 30 mg (daily) at + 220%, Dapoxetine 30 mg (on demand) at + 197%, and Silodosin at + 149.5% All within-group comparisons were statistically significant (P < 0.001). In terms of subjective outcomes (Table dapoxetine 60 mg tablets 3), all treatment groups showed statistically significant improvements in PEPQ scores (P < 0.001), reflecting enhanced ejaculatory control, sexual satisfaction, and reduced personal distress and interpersonal difficulty. Among the groups, Citalopram resulted in the highest median percentage improvement (300%), followed by Dapoxetine 30 mg (daily) (225%), Dapoxetine 30 mg (on demand) (166.7%), and Silodosin (175%). This is consistent with other studies in this field, which also found no significant baseline differences across treatment groups [11, 12].
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◦ Persistent or recurrent ejaculation within approximately 1 minute of vaginal penetration (confirmed by stopwatch-measured IELT ≤60 seconds at baseline) ◦ Persistent or recurrent ejaculation within approximately 1 minute of vaginal penetration (confirmed by stopwatch-measured IELT ≤60 seconds at baseline) ◦ Inability to delay ejaculation during all or nearly all vaginal penetrations ◦ Inability to delay ejaculation during all or nearly all vaginal penetrations ◦ Negative personal consequences (distress, frustration, avoidance of sexual intimacy) ◦ Negative personal consequences (distress, frustration, avoidance of sexual intimacy) dapoxetine 5mg Premature Ejaculation Diagnostic Tool (PEDT) score ≥11. Premature Ejaculation Diagnostic Tool (PEDT) score ≥11. In a stable, monogamous, heterosexual relationship for at least 3 months. Signed informed consent indicating willingness to participate. Use of PE medications in the preceding 4 weeks.
Sample size calculation
Patients with erectile dysfunction through medical history. History of psychiatric or significant physical disorders (in either patient or partner). Use of antidepressants, local anesthetic sprays, intracavernosal injections, or psychotherapy within 4 weeks. Participants were randomly assigned to four equal groups (n = 100 each) using a computer-generated and centralized randomization: Group A: Received Citalopram hydrobromide, starting with 10 mg once daily for 1 week, followed by 20 mg once daily for 10 weeks, and 10 mg daily during the final week (tapered). Group A: Received Citalopram hydrobromide, starting with 10 mg once daily for 1 week, followed by 20 mg once daily for 10 weeks, and 10 mg daily during the final week (tapered). The results demonstrated significant increases in IELT across all treatment groups, with the most substantial improvement observed in the Citalopram group.
- Dapoxetine is designed specifically for men with PE.
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Increasing IELT represents a considerable improvement in ejaculation latency. These results corroborate previous studies indicating that SSRIs like citalopram are highly effective in prolonging ejaculation latency [13, 14].
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